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    Understanding Document Comparison Software: A Key Tool for Regulatory Affairs in Crop Science

    September 27, 2024

    By: Marc Chaillou 4 minutes read

    Understanding Document Comparison Software: A Key Tool for Regulatory Affairs in Crop Science

    Much like in the pharmaceutical and medical device sectors, where the adoption of such software has proven to reduce workloads and the risk of errors that may cause recalls or stop-sales, the Crop Science industry is also beginning to recognize the value of integrating this technology.

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    Rising regulatory demands: are medical device suppliers ready?

    September 9, 2024

    By: Peter Muller 3 minutes read

    Rising regulatory demands: are medical device suppliers ready?

    The global medical devices market is set to reach $886.80 billion in value by 2032 . As devices become more critical to patient outcomes, regulators’ quality and safety expectations and associated controls are increasing.

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    FHIR: Transforming Product Labeling

    August 22, 2024

    By: Mike Baird 6 minutes read

    FHIR: Transforming Product Labeling

    The shift from paper-based to digital processes has opened enormous opportunities in the healthcare sector in terms of data sharing and content management. But data can only be shared efficiently and add value if systems can "talk" to each other. The term we use for how compatibly systems work together is "interoperability." Traditionally, the healthcare sector has suffered from a high lack of interoperability.

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    Empowering Pharma and Regulatory Frameworks with Structured Content

    August 15, 2024

    By: Mike Baird 5 minutes read

    Empowering Pharma and Regulatory Frameworks with Structured Content

    Structured content ensures compliance in the pharmaceutical industry. Discover how FDA’s SPL and Canada’s SPM formats promote patient safety and efficiency.

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    The Importance of Structured Content in Product Labeling

    August 9, 2024

    By: Mike Baird 4 minutes read

    The Importance of Structured Content in Product Labeling

    In the first of a three-part series on structured content and structured product labeling, we explore why structured content is important, its benefits, and best practices for implementation.

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    The Critical Impact of Labeling Errors in the Pharmaceutical Industry

    August 8, 2024

    By: Vineed Ravindranath 2 minutes read

    The Critical Impact of Labeling Errors in the Pharmaceutical Industry

    In the complex landscape of pharmaceutical manufacturing, every detail matters. From the formulation of the drug to its packaging and labeling, precision is vital. However, despite stringent regulations and quality control measures, labeling errors persist, posing significant risks to patient safety and public health.

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    Regulatory Tools: Revolutionizing Promo Review

    June 11, 2024

    By: Peter Muller 5 minutes read

    Regulatory Tools: Revolutionizing Promo Review

    Regulatory authorities are approaching AI with understandable caution, recognizing its obvious opportunities as well as its inherent challenges. Workshops, workplans, input and industry collaboration are high on the agenda.

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    How TVT helps the Top 5 Functions of Regulatory Professionals

    June 5, 2024

    By: Peter Muller 3 minutes read

    How TVT helps the Top 5 Functions of Regulatory Professionals

    The challenges faced by regulatory professionals are substantial. New products must be brought to market quickly and the pressure is on to turn projects around faster. Furthermore, regulations are constantly evolving, which means labeling and packaging must be updated.

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    Off Label Marketing: How to Avoid False Claims in Pharma

    May 17, 2024

    By: Peter Muller 4 minutes read

    Off Label Marketing: How to Avoid False Claims in Pharma

    The risk is high, whichever side of the coin you look at. Off-label marketing and other off-label promotion have led to some of the largest legal settlements in the pharmaceutical industry – up to $3 billion in one case

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    Navigating Medical Device Regulations: How to Meet Labeling Artwork Compliance Standards

    May 8, 2024

    By: Marc Chaillou 4 minutes read

    Navigating Medical Device Regulations: How to Meet Labeling Artwork Compliance Standards

    The medical devices regulations (MDRs) were introduced to take account of scientific and technological advances over the past two decades, but also due to problems interpreting previously existing regulations.

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    The Ripple Effect: Exploring the Extensive Costs Associated with Product Recalls

    April 24, 2024

    By: Vineed Ravindranath 4 minutes read

    The Ripple Effect: Exploring the Extensive Costs Associated with Product Recalls

    It takes endurance and the tools of skilled professionals to advance a new product from R&D through to market. The investment is enormous, and the competition is breathing down the innovator's neck. Can you afford the costs of a recall or product delay?

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    Sustainable Solutions: Enhancing Workflows through Paperless Document Reviews

    April 8, 2024

    By: Dr. Jutta Hohenhoerst 4 minutes read

    Sustainable Solutions: Enhancing Workflows through Paperless Document Reviews

    Earth Day is a commitment to safeguarding and enhancing our natural environment, with an anticipated mobilization of over 1 billion people in 2024. At Schlafender Hase, when we thought about how Earth Day affected us as individuals and a company, we unanimously agreed: it's especially about trees and minimizing use of paper.

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    Best Practices for your Promotional Review Process

    March 22, 2024

    By: Peter Muller 5 minutes read

    Best Practices for your Promotional Review Process

    The aim of a pharmaceutical promotional review process is to ensure the accuracy and compliance of promotional material with the relevant medical, legal, and regulatory aspects of a specific market.

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    Ensuring Patient Safety: Medical Device Recall Process and Prevention Strategies

    March 18, 2024

    By: Katarina Kresankova 4 minutes read

    Ensuring Patient Safety: Medical Device Recall Process and Prevention Strategies

    The costs of medical device recalls can run well into the millions of dollars. In terms of numbers of devices recalled, heading the unfortunate list of medical device recalls in recent times is a Class I recall of 38 million Vial2Bag fluid transfer systems by West Pharmaceuticals in 2019.

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    Proofreading Regulated Documents in Pharma

    February 15, 2024

    By: Dean Halliday 4 minutes read

    Proofreading Regulated Documents in Pharma

    Proofreading regulated documents in pharma presents unique challenges. Avoid the high risk of costly mistakes with best practices and by leveraging technology.

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    A Guide to Proofreading Medical Writing

    February 12, 2024

    By: Peter Muller 4 minutes read

    A Guide to Proofreading Medical Writing

    Medical writing describes a wide range of writing in the fields of medicine and healthcare. Discover more about medical writing and “a day in the life.”

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    Proofreading Software: 6 Savings in 2024

    January 16, 2024

    By: Marc Chaillou 4 minutes read

    Proofreading Software: 6 Savings in 2024

    Comparison software offers immense savings, especially in regulated industries. Ask some of the leading pharmaceutical companies. Here are 6 Ways You Save.

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    Best Practices for Labeling Readability

    January 15, 2024

    By: Dean Halliday 4 minutes read

    Best Practices for Labeling Readability

    We will explore what we mean by readability and what key principles can guide us through regulations to make labeling readable and legible.

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    Preparing for MoCRA – FDA’s Updated Cosmetics Framework

    December 8, 2023

    By: Peter Muller 5 minutes read

    Preparing for MoCRA – FDA’s Updated Cosmetics Framework

    The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant change to cosmetics regulation since 1938. Are you prepared?

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    Comparison Software to Verify Drug Promotional Material

    November 30, 2023

    By: Peter Muller 4 minutes read

    Comparison Software to Verify Drug Promotional Material

    Ten years and $1 billion later, close your eyes and imagine; your product has been approved in the US by the Food and Drug Administration (FDA).

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    8 Ways Barcodes Can Combat Counterfeit Medical Products

    November 30, 2023

    By: Vineed Ravindranath 3 minutes read

    8 Ways Barcodes Can Combat Counterfeit Medical Products

    Counterfeit medical products, including drugs and devices, pose a serious global threat to public health.

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    How To Ensure Your Labels Are Always Compliant

    October 16, 2023

    By: Philipp Thomas 4 minutes read

    How To Ensure Your Labels Are Always Compliant

    Labeling compliance is important. Find out why, and discover how you can ensure your product labeling is compliant with regulations for pharmaceutical and food products.

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    9 Reasons Proofreading in Life Sciences Can Be a Nightmare

    October 2, 2023

    By: Marc Chaillou 3 minutes read

    9 Reasons Proofreading in Life Sciences Can Be a Nightmare

    Risks, stress and more – there’s a lot at stake when you proofread in regulated industries. Here are nine reasons why proofreading in life sciences can be a nightmare.

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    The Importance of Braille Inspection on Packaging

    September 22, 2023

    By: Dean Halliday 4 minutes read

    The Importance of Braille Inspection on Packaging

    Inspecting Braille on packaging is important for compliance in the pharmaceutical industry. Automated proofreading supports you with Braille inspection.

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    Top Medical Device use Document Comparison Software

    September 20, 2023

    By: Dean Halliday 4 minutes read

    Top Medical Device use Document Comparison Software

    When the subject of proofreading comes up, most think of correcting written text in a document such as a book or a school essay. In the Medical Device industry, however, proofreading is a whole lot more than that. Packaging and labeling can include many elements such as instructions for use, company logo, symbols and numerous other graphics, as well as a variety of different barcodes. Everything has a purpose and must be correct before a device goes to market.

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    5 Must-Do Activities in Montreal During RAPS Convergence 2023

    September 18, 2023

    By: Peter Muller 2 minutes read

    5 Must-Do Activities in Montreal During RAPS Convergence 2023

    Welcome, esteemed professionals attending RAPS Convergence in Montreal! To help you experience the best of what Montreal has to offer, we've compiled a list of five must-do activities during your visit. Get ready to explore the charm and excitement of this captivating Canadian metropolis!

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    Top Pharma use Document Comparison Software

    September 14, 2023

    By: Dean Halliday 4 minutes read

    Top Pharma use Document Comparison Software

    Top Pharma use document comparison software to proofread labeling. Why aren’t you? When the subject of proofreading comes up, most think of correcting written text in a document such as a book or a school essay. In the Pharma industry, however, proofreading is a whole lot more than that. Packaging and labeling include elements such ... Read more

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    A Short History of Regulatory Authorities

    August 17, 2023

    By: Mike Baird 4 minutes read

    A Short History of Regulatory Authorities

    Regulatory authorities are crucial for the safety and efficacy of medicines and medical devices. And yet, achieving the high level of regulation we have today has been a long road – with lives saved and lost along the way.

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    A Guide to Medical Device Labeling Requirements

    August 17, 2023

    By: Vineed Ravindranath 4 minutes read

    A Guide to Medical Device Labeling Requirements

    Navigating complex labeling requirements for medical devices. Your guide to the fundamentals of regulation and compliance and how automated proofreading can minimize your labeling risks.

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    Maximizing the benefits of e-labeling in Pharma and Med Device

    July 31, 2023

    By: Philipp Thomas 5 minutes read

    Maximizing the benefits of e-labeling in Pharma and Med Device

    With electronic labeling gaining momentum across healthcare markets, are you ready to maximize the benefits?

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    Artwork Approval Processes for Pharma & Med Device

    July 31, 2023

    By: Dean Halliday 5 minutes read

    Artwork Approval Processes for Pharma & Med Device

    Improving artwork design and artwork approval processes can save patient lives and enhance company viability.

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    5 Ways a Proofreading Software will Keep your Regulatory Affairs Team Happy

    June 28, 2023

    By: Vineed Ravindranath 2 minutes read

    5 Ways a Proofreading Software will Keep your Regulatory Affairs Team Happy

    Proofreading documents manually in regulatory affairs (RA) in the life sciences industry is stressful, high-risk and can lead to job dissatisfaction. The stakes are high – errors can harm patient health, result in product recalls, and damage brand and company reputations. Here’s how TVT, the proofreading software for regulatory affairs, can keep an RA team happy.

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    Why Spelling Errors Can Be Lethal in Medical Packaging

    June 21, 2023

    By: Katarina Kresankova 4 minutes read

    Why Spelling Errors Can Be Lethal in Medical Packaging

    Spelling errors, missing information and language mistakes can lead to medical errors that put patient health at risk. Additionally, such errors can result in misprints, CAPA’s and product recalls.

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    How to Reduce Drug Labeling Errors in Pharma

    May 26, 2023

    By: Katarina Kresankova 3 minutes read

    How to Reduce Drug Labeling Errors in Pharma

    FDA (US), EMA (EU), ANSM (France), CFDA (China), BfArM (Germany) – just to name a few of the national and international bodies that regulate the pharmaceutical industry. They share a common purpose: to ensure the patient safety and efficacy of medicines. And for this, they have regulatory procedures.

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    Regulatory Guidelines for Labeling in Pharma

    May 23, 2023

    By: Peter Muller 5 minutes read

    Regulatory Guidelines for Labeling in Pharma

    Pharmaceutical labeling is a critical element of healthcare products and services that are strictly regulated by health authorities. This includes the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe. The FDA oversees the safety and efficacy of pharmaceutical drugs, biopharmaceuticals, and other healthcare products. As a result, pharmaceutical labeling is a complex and meticulous process, with even minor errors resulting in significant consequences.

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    Regulatory Affairs – Partnering for Knowledge

    May 8, 2023

    By: Peter Muller 2 minutes read

    Regulatory Affairs – Partnering for Knowledge

    As a company that was built around a specific need for Regulatory Affairs (RA), we must also remain on top of regulatory developments. Ensuring our software continues to meet the needs of RA professionals. Our top resource is RAPS, the Regulatory Affairs Professionals Society and in this article we look at our partnership with RAPS and the importance of this organization.  

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    Why is labeling important in the pharmaceutical industry?

    May 3, 2023

    By: Dean Halliday 4 minutes read

    Why is labeling important in the pharmaceutical industry?

    Bringing a new drug to market demands a large investment on the part of a pharmaceutical company – often, $ 1 billion or more. Ensuring compliance with complex labeling regulations is part of that investment. In the following we look at why pharmaceutical labeling is so important and the different types of labeling.

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    What is Document Comparison Software For Regulatory Affairs?

    March 15, 2023

    By: Philipp Thomas 5 minutes read

    What is Document Comparison Software For Regulatory Affairs?

    The major players in the Pharma and Medical Devices industries have either adopted or are in the process of adopting a software for document comparison. Like other technologies, this too has been a slow adoption despite it’s proven time, money, and stress savings. The goal of this article is to explain how document comparison software can help and why it is an essential part of any Regulatory Affairs tech stack.

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    E-Labelling: Practical Next Steps for Medical Device Manufacturers

    March 6, 2023

    4 minutes read

    E-Labelling: Practical Next Steps for Medical Device Manufacturers

    Practical next steps for medical device manufacturers & distributors as regulators demand the digital delivery of customer-facing product information in place of paper inserts.

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    8 Ways RA can help get Products to Market Faster

    March 2, 2023

    By: Philipp Thomas 5 minutes read

    8 Ways RA can help get Products to Market Faster

    Bringing a new drug to market is time-consuming and costly, and generally takes 10 years and costs over $1 billion. The smallest lapse in labeling and packaging can jeopardize even the most well-planned submission. A proofreading and comparison software can help you get there faster, safer.

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    5 Ways You’re Wasting Time & Money in Regulatory Affairs

    March 1, 2023

    By: Dean Halliday 5 minutes read

    5 Ways You’re Wasting Time & Money in Regulatory Affairs

    If you are proofreading manually, you are aware of how time-consuming it is. We have all heard the saying “time is money”, and this is very true for Regulatory Affairs professionals. In this article, we'll be exploring proofreading in Regulatory Affairs, and 5 ways that RA depts. are wasting money by relying on manual proofreading.

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    13 Questions to Ask When Choosing Comparison Software

    February 2, 2023

    By: Peter Muller 4 minutes read

    13 Questions to Ask When Choosing Comparison Software

    Settling on a text comparison solution that does not require you to change your existing processes can be a daunting task, but we are here to help! We’ve outlined 13 questions for you to ask before making your final choice.

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    11 Ways Proofreading Is Easier with TVT 11

    November 10, 2022

    By: Mike Baird 3 minutes read

    11 Ways Proofreading Is Easier with TVT 11

    Using a proofreading software like TVT®, takes the stress out of proofreading by automating tasks.

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    How to Attract and Retain Regulatory Affairs Professionals

    September 20, 2022

    By: Katarina Kresankova 4 minutes read

    How to Attract and Retain Regulatory Affairs Professionals

    As we move through 2022, Human Resource (HR) departments and recruiters are looking at the impact of the Great Resignation on regulatory affairs. The current trend to job switching, the “Great Resignation”, may be flattening out in some professions in mid-2022, but the difficulty of attracting and retaining top talent in regulatory affairs remains an ongoing challenge for pharmaceutical companies, and the stakes are high.

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    10  Automated Proofreading Benefits that Make Your Life Easier

    September 8, 2022

    By: Philipp Thomas 4 minutes read

    10 Automated Proofreading Benefits that Make Your Life Easier

    Whether you proofread labeling and packaging full-time, or proofreading is just one of your many tasks in your working day, automated proofreading with TVT, the Text Verification Tool©, will make your life easier.

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    Barocde Compliance: 3 Rules for Barcodes in Life Sciences

    August 10, 2022

    By: Mike Baird 2 minutes read

    Barocde Compliance: 3 Rules for Barcodes in Life Sciences

    Optimize barcode scanning precision in pharmaceutical, artwork, quality control, packaging, and printing industries with these indispensable tips. Avoid delays and errors for smooth workflow.

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    Top Pharma Companies Automate Proofreading

    July 15, 2022

    By: Dean Halliday 3 minutes read

    Top Pharma Companies Automate Proofreading

    Top pharma companies automate proofreading with TVT. Read all top 10 reasons.

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    Are You Struggling to Proofread Foreign Languages or Braille?

    June 21, 2022

    By: Philipp Thomas 4 minutes read

    Are You Struggling to Proofread Foreign Languages or Braille?

    “A different language is a different vision of life,” said the Italian film director, Federico Fellini.

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    Manual vs Automated Proofreading

    June 10, 2022

    By: Philipp Thomas 3 minutes read

    Manual vs Automated Proofreading

    When was the last time you flew in a passenger jet? Would you have felt as safe if the jet didn’t have automated controls? These relieve pilots of repetitive actions, reducing the risk of error and allowing pilots to focus on broader tasks related to safety and operation.

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    Why Data Integrity is Important in Pharma

    May 20, 2022

    By: Dr. Jutta Hohenhoerst 3 minutes read

    Why Data Integrity is Important in Pharma

    Learn about Data Integrity and its crucial role in maintaining valuable data for various stakeholders, including patients, communities, and companies, through ALCOA and ALCOA+ principles.

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    The True Cost of Manual Proofreading in Regulated Industries

    May 17, 2022

    By: Katarina Kresankova 3 minutes read

    The True Cost of Manual Proofreading in Regulated Industries

    Looking for more information on how you can improve your team’s proofreading practices? Learn how Lohmann & Rauscher reduced the number of correction cycles and gained significant time back by implementing TVT in their proofreading process.

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    8 Secrets Proofreaders Don’t Want to Reveal

    March 25, 2022

    By: Marc Chaillou 3 minutes read

    8 Secrets Proofreaders Don’t Want to Reveal

    First, by proofreading, we mean text comparison of 2 files, like a manuscript versus a laid-out artwork of what should be the same text, not content correction of a single text. Over the years, many proofreaders have shared with us what manual text comparison really means for them. When they try to convince their boss to invest in electronic text comparison software, they usually present the business reasons, discussing ROI, risk avoidance, improved quality, time savings and so on.

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    The Story Behind the Name | Schlafender Hase

    March 9, 2022

    By: Schlafender Hase 2 minutes read

    The Story Behind the Name | Schlafender Hase

    Ask Frank Hessler, founding CEO of Schlafender Hase, how the company name “Sleeping Rabbit” came about and a wry smile crosses his face. "We're sometimes asked this by customers, and to be honest, it's a simple story. It dates back to the early 2000s when we used a code name to talk about the company. I know it's usual to have a generic code name like "New Company", but we were different. The inspiration was a fluffy toy hanging on a rear vision mirror of a friend's car. We found this amusing, and somehow this fluffy rabbit just established itself. We used it so often that the name stuck.”

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    What Bill Murray and Text Comparison Have in Common

    February 21, 2022

    By: Marc Chaillou 2 minutes read

    What Bill Murray and Text Comparison Have in Common

    Ready to put an end to repetitive correction cycles?

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    Laser-focused on Digital Workflows in the Era of Pharma 4.0

    January 4, 2022

    By: Mike Baird 4 minutes read

    Laser-focused on Digital Workflows in the Era of Pharma 4.0

    Pharma 4.0 is changing the landscape of the pharmaceutical industry, with a similar quiet revolution also taking place in proofreading through automation and transparency. This is illustrated by the enhancements in the new Version 10.2 of TVT®.

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    Reduce Labeling Errors in Your Artwork

    December 21, 2021

    By: Mike Baird 12 minutes read

    Reduce Labeling Errors in Your Artwork

    Over the years, as we’ve worked to help make proofreading easier and more accurate for our customers, we’ve witnessed many different types of potential issues with labeling artwork design proofs. Most of these issues are visible to the human eye when reading through the document, but a few of them are invisible and require special techniques.

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    Understanding Unicode for Proofreaders

    November 17, 2021

    By: Marc Chaillou 4 minutes read

    Understanding Unicode for Proofreaders

    Unicode is a computer and software industry standard for handling text. While it is possible to geek-out on the technical aspects of Unicode (and if you’re so inclined you can check out the Wikipedia page on Unicode and the Unicode Consortium website), in this article we’re going to focus more on understanding the fundamentals, and discuss why this basic knowledge is critical for anyone who is part of a document creation / editing / review / correction workflow in a highly regulated industry.

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    10 Historically Expensive Recalls in Pharma

    November 12, 2021

    By: Vineed Ravindranath 3 minutes read

    10 Historically Expensive Recalls in Pharma

    Curious about the history of pharmaceutical recalls and the billions of dollars lost?  Please see below for 10 pricey issues and the health risks associated behind the reason for the recalls.

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    Live vs. Rasterized vs. Vectorized Text

    October 20, 2021

    By: Marc Chaillou 4 minutes read

    Live vs. Rasterized vs. Vectorized Text

    In a previous post, we covered the basics of Unicode and why it’s so important for proofreaders (or anyone involved in the document creation, review and correction workflow) to understand the differences between the way humans and computers read language. Today, we’ll build on that knowledge as we examine different ways design and print proofs can be exported to PDF and the risks associated with removing live text from your organization’s documents.

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    Common Labeling Errors That  Lead to Pharmaceutical Recalls

    October 12, 2021

    By: Marc Chaillou 4 minutes read

    Common Labeling Errors That Lead to Pharmaceutical Recalls

    Explore the impact of labeling errors on pharmaceutical recalls. Find out how to avoid these mistakes and maintain compliance with industry regulations.

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    MDR e-Labeling

    October 6, 2021

    By: Marc Chaillou 2 minutes read

    MDR e-Labeling

    The EU Medical Device Regulations (MDR) states any device manufacturer with a website must publish user information in electronic form.

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    MDR Graphic Symbols

    October 6, 2021

    By: Marc Chaillou 2 minutes read

    MDR Graphic Symbols

    Over the last few posts, we have been touching upon different labelling requirements set by the MDR.

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    Medical Devices Regulation EU 2017/745

    September 30, 2021

    By: Mike Baird 2 minutes read

    Medical Devices Regulation EU 2017/745

    Medical Devices Regulation (MDR) updates represent a step towards higher labeling standards.

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    MDR UDI and Device Registration

    September 22, 2021

    By: Marc Chaillou 2 minutes read

    MDR UDI and Device Registration

    The new European Database on Medical Devices, known as EUDAMED, was originally scheduled to launch in May 2020,

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    Top 3 reasons to encourage your employees to participate in e-Learning

    September 6, 2021

    By: Dr. Jutta Hohenhoerst 3 minutes read

    Top 3 reasons to encourage your employees to participate in e-Learning

    As part of our TVT e-Learning portal we are offering a free trial to anyone interested in getting a feel for the system.

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    Top 8 Reasons for Mistakes in Your PDF Artwork

    August 25, 2021

    By: Philipp Thomas 3 minutes read

    Top 8 Reasons for Mistakes in Your PDF Artwork

    As you can see, the way in which the graphic designer / typesetter works as well as the tools and processes they use will influence the quality and content of the PDF Artwork.

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    Make Sure Your Barcode Makes the Grade

    August 11, 2021

    By: Mike Baird 4 minutes read

    Make Sure Your Barcode Makes the Grade

    In this interview, Mike Baird talks about TVT Barcode and what TVT customers can expect from this new module and the newly released version 10.2 of TVT, the Text Verification Tool.

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    Four Tips for Regulatory Affairs to Proofread Braille

    July 15, 2021

    By: Marc Chaillou 3 minutes read

    Four Tips for Regulatory Affairs to Proofread Braille

    If you are part of a Labelling, Packaging, Graphics or Regulatory Affairs Department, these four tips will save time, and reduce risk and stress due to a missed error – even if you don’t have access to software capable of reading Braille. Since some European regulatory bodies mandate important information such as product name and dosage be written in Braille on packaging, knowing how to ensure Braille accuracy will be an asset for you and your specific life sciences company.

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    Enhancing Your Workflow with Mike Baird

    June 17, 2021

    By: Mike Baird 4 minutes read

    Enhancing Your Workflow with Mike Baird

    Mike Baird, Director of Product Management at Schlafender Hase responds to user questions.

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    TVT Critical Word List Finds Common Proofreading Mistakes in Original Documents

    June 2, 2021

    By: Dr. Jutta Hohenhoerst 2 minutes read

    TVT Critical Word List Finds Common Proofreading Mistakes in Original Documents

    by: Schlafender Hase

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    O.K., So You Must Do a Manual Proofread?

    May 3, 2021

    By: Marc Chaillou 2 minutes read

    O.K., So You Must Do a Manual Proofread?

    The meaning of O.K. stems from the words “all correct”, spelled incorrectly.

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    Risks of Converting Documents in the Pharmaceutical Industry

    April 22, 2021

    By: Marc Chaillou 2 minutes read

    Risks of Converting Documents in the Pharmaceutical Industry

    Discover the dangers involved in converting documents within the pharmaceutical sector. Find valuable insights and strategies to address these risks in our article.

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    The EMA and TVT

    March 16, 2021

    By: Marc Chaillou 2 minutes read

    The EMA and TVT

    Hey! Regulatory affairs professionals! The European Medicines Agency (EMA) has been using TVT, the Text Verification Tool® since 2004!

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    Future-Proof Your Regulatory Submissions – Increasing Efficiency and Quality With Information Management Systems

    February 16, 2021

    By: Peter Muller 3 minutes read

    Future-Proof Your Regulatory Submissions – Increasing Efficiency and Quality With Information Management Systems

    Information and data management is an integral part of regulatory compliance across the globe, particularly in the highly regulated pharmaceuticals and medical device industries. These systems support industry by providing highly specialized as well as essential services. Companies benefit from these by being able to develop harmonious strategies and systems that evolve as regulations change. Whether you are currently using information management systems or just setting out, there are some key aspects you need to consider if you want to get it right. This will also be the topic of an upcoming webinar on 23 February 2021.

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    The Art of Listening

    December 15, 2020

    By: Katarina Kresankova 4 minutes read

    The Art of Listening

    The year ends, even a year as difficult as 2020. At the end you look back, you look ahead. In comparison, making a Christmas list is easy.

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    TVT Connect works with Your Information Management System

    November 17, 2020

    By: Mike Baird 3 minutes read

    TVT Connect works with Your Information Management System

    If you would like to know more about TVT Connect and integration with information management systems, contact us:

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    How to Compare Excel Files: To Improve your Proofreading Workflow

    October 8, 2020

    By: Marc Chaillou 3 minutes read

    How to Compare Excel Files: To Improve your Proofreading Workflow

    Yes, this can be a common situation: a Brand Owner submits the packaging or labeling brief in multiple file formats using an Excel spreadsheet combined with a Word document. Critical, legally required table information such as nutrition facts and allergens arrive in Excel templates. These Excel files are used to generate label revisions which comply with FDA regulations.

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    The Rabbit Rebrand

    October 1, 2019

    By: Schlafender Hase 5 minutes read

    The Rabbit Rebrand

    Schlafender Hase’s proofreading software, TVT®, the Text Verification Tool®, has been catching errors on packaging and labels of life sciences products for 15 years now. CEO Frank Hessler and Head of Marketing, Kindrie Eaton take a look at the company’s past with a view toward its future and their rebrand.

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    Are You a Medical Device Manufacturer?

    July 25, 2019

    By: Dr. Jutta Hohenhoerst 4 minutes read

    Are You a Medical Device Manufacturer?

    The regulation on medical devices 2017/745, widely known as the EU MDR, was released in May 2017 with regulation 2017/746 on in vitro diagnostics. EU MDR and regulation 2017/746 replaced Council Directive 93/42/EEC, also known as the Medical Device Directive (MDD), and Directive 98/79/EC on in vitro diagnostic medical devices.

    Read More!
    Medical Device Recalls

    June 13, 2018

    By: Peter Muller < 1 minute read

    Medical Device Recalls

    The majority of medical device recalls are due to labeling or software - HMI issues. TVT can help keep you from becoming a statistic.

    Read More!
    2 Biggest Myths in Electronic Proofreading

    August 17, 2015

    By: Marc Chaillou < 1 minute read

    2 Biggest Myths in Electronic Proofreading

    Below are what I consider as the top 2 biggest misunderstandings regarding electronic proofreading.

    Read More!

Blogs

    Understanding Document Comparison Software: A Key Tool for Regulatory Affairs in Crop Science

    September 27, 2024

    By: Marc Chaillou 4 minutes read

    Understanding Document Comparison Software: A Key Tool for Regulatory Affairs in Crop Science

    Much like in the pharmaceutical and medical device sectors, where the adoption of such software has proven to reduce workloads and the risk of errors that may cause recalls or stop-sales, the Crop Science industry is also beginning to recognize the value of integrating this technology.

    Read More!
    Rising regulatory demands: are medical device suppliers ready?

    September 9, 2024

    By: Peter Muller 3 minutes read

    Rising regulatory demands: are medical device suppliers ready?

    The global medical devices market is set to reach $886.80 billion in value by 2032 . As devices become more critical to patient outcomes, regulators’ quality and safety expectations and associated controls are increasing.

    Read More!
    FHIR: Transforming Product Labeling

    August 22, 2024

    By: Mike Baird 6 minutes read

    FHIR: Transforming Product Labeling

    The shift from paper-based to digital processes has opened enormous opportunities in the healthcare sector in terms of data sharing and content management. But data can only be shared efficiently and add value if systems can "talk" to each other. The term we use for how compatibly systems work together is "interoperability." Traditionally, the healthcare sector has suffered from a high lack of interoperability.

    Read More!
    Empowering Pharma and Regulatory Frameworks with Structured Content

    August 15, 2024

    By: Mike Baird 5 minutes read

    Empowering Pharma and Regulatory Frameworks with Structured Content

    Structured content ensures compliance in the pharmaceutical industry. Discover how FDA’s SPL and Canada’s SPM formats promote patient safety and efficiency.

    Read More!
    The Importance of Structured Content in Product Labeling

    August 9, 2024

    By: Mike Baird 4 minutes read

    The Importance of Structured Content in Product Labeling

    In the first of a three-part series on structured content and structured product labeling, we explore why structured content is important, its benefits, and best practices for implementation.

    Read More!
    The Critical Impact of Labeling Errors in the Pharmaceutical Industry

    August 8, 2024

    By: Vineed Ravindranath 2 minutes read

    The Critical Impact of Labeling Errors in the Pharmaceutical Industry

    In the complex landscape of pharmaceutical manufacturing, every detail matters. From the formulation of the drug to its packaging and labeling, precision is vital. However, despite stringent regulations and quality control measures, labeling errors persist, posing significant risks to patient safety and public health.

    Read More!
    Regulatory Tools: Revolutionizing Promo Review

    June 11, 2024

    By: Peter Muller 5 minutes read

    Regulatory Tools: Revolutionizing Promo Review

    Regulatory authorities are approaching AI with understandable caution, recognizing its obvious opportunities as well as its inherent challenges. Workshops, workplans, input and industry collaboration are high on the agenda.

    Read More!
    How TVT helps the Top 5 Functions of Regulatory Professionals

    June 5, 2024

    By: Peter Muller 3 minutes read

    How TVT helps the Top 5 Functions of Regulatory Professionals

    The challenges faced by regulatory professionals are substantial. New products must be brought to market quickly and the pressure is on to turn projects around faster. Furthermore, regulations are constantly evolving, which means labeling and packaging must be updated.

    Read More!
    Off Label Marketing: How to Avoid False Claims in Pharma

    May 17, 2024

    By: Peter Muller 4 minutes read

    Off Label Marketing: How to Avoid False Claims in Pharma

    The risk is high, whichever side of the coin you look at. Off-label marketing and other off-label promotion have led to some of the largest legal settlements in the pharmaceutical industry – up to $3 billion in one case

    Read More!
    Navigating Medical Device Regulations: How to Meet Labeling Artwork Compliance Standards

    May 8, 2024

    By: Marc Chaillou 4 minutes read

    Navigating Medical Device Regulations: How to Meet Labeling Artwork Compliance Standards

    The medical devices regulations (MDRs) were introduced to take account of scientific and technological advances over the past two decades, but also due to problems interpreting previously existing regulations.

    Read More!
    The Ripple Effect: Exploring the Extensive Costs Associated with Product Recalls

    April 24, 2024

    By: Vineed Ravindranath 4 minutes read

    The Ripple Effect: Exploring the Extensive Costs Associated with Product Recalls

    It takes endurance and the tools of skilled professionals to advance a new product from R&D through to market. The investment is enormous, and the competition is breathing down the innovator's neck. Can you afford the costs of a recall or product delay?

    Read More!
    Sustainable Solutions: Enhancing Workflows through Paperless Document Reviews

    April 8, 2024

    By: Dr. Jutta Hohenhoerst 4 minutes read

    Sustainable Solutions: Enhancing Workflows through Paperless Document Reviews

    Earth Day is a commitment to safeguarding and enhancing our natural environment, with an anticipated mobilization of over 1 billion people in 2024. At Schlafender Hase, when we thought about how Earth Day affected us as individuals and a company, we unanimously agreed: it's especially about trees and minimizing use of paper.

    Read More!
    Best Practices for your Promotional Review Process

    March 22, 2024

    By: Peter Muller 5 minutes read

    Best Practices for your Promotional Review Process

    The aim of a pharmaceutical promotional review process is to ensure the accuracy and compliance of promotional material with the relevant medical, legal, and regulatory aspects of a specific market.

    Read More!
    Ensuring Patient Safety: Medical Device Recall Process and Prevention Strategies

    March 18, 2024

    By: Katarina Kresankova 4 minutes read

    Ensuring Patient Safety: Medical Device Recall Process and Prevention Strategies

    The costs of medical device recalls can run well into the millions of dollars. In terms of numbers of devices recalled, heading the unfortunate list of medical device recalls in recent times is a Class I recall of 38 million Vial2Bag fluid transfer systems by West Pharmaceuticals in 2019.

    Read More!
    Proofreading Regulated Documents in Pharma

    February 15, 2024

    By: Dean Halliday 4 minutes read

    Proofreading Regulated Documents in Pharma

    Proofreading regulated documents in pharma presents unique challenges. Avoid the high risk of costly mistakes with best practices and by leveraging technology.

    Read More!
    A Guide to Proofreading Medical Writing

    February 12, 2024

    By: Peter Muller 4 minutes read

    A Guide to Proofreading Medical Writing

    Medical writing describes a wide range of writing in the fields of medicine and healthcare. Discover more about medical writing and “a day in the life.”

    Read More!
    Proofreading Software: 6 Savings in 2024

    January 16, 2024

    By: Marc Chaillou 4 minutes read

    Proofreading Software: 6 Savings in 2024

    Comparison software offers immense savings, especially in regulated industries. Ask some of the leading pharmaceutical companies. Here are 6 Ways You Save.

    Read More!
    Best Practices for Labeling Readability

    January 15, 2024

    By: Dean Halliday 4 minutes read

    Best Practices for Labeling Readability

    We will explore what we mean by readability and what key principles can guide us through regulations to make labeling readable and legible.

    Read More!
    Preparing for MoCRA – FDA’s Updated Cosmetics Framework

    December 8, 2023

    By: Peter Muller 5 minutes read

    Preparing for MoCRA – FDA’s Updated Cosmetics Framework

    The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant change to cosmetics regulation since 1938. Are you prepared?

    Read More!
    Comparison Software to Verify Drug Promotional Material

    November 30, 2023

    By: Peter Muller 4 minutes read

    Comparison Software to Verify Drug Promotional Material

    Ten years and $1 billion later, close your eyes and imagine; your product has been approved in the US by the Food and Drug Administration (FDA).

    Read More!
    8 Ways Barcodes Can Combat Counterfeit Medical Products

    November 30, 2023

    By: Vineed Ravindranath 3 minutes read

    8 Ways Barcodes Can Combat Counterfeit Medical Products

    Counterfeit medical products, including drugs and devices, pose a serious global threat to public health.

    Read More!
    How To Ensure Your Labels Are Always Compliant

    October 16, 2023

    By: Philipp Thomas 4 minutes read

    How To Ensure Your Labels Are Always Compliant

    Labeling compliance is important. Find out why, and discover how you can ensure your product labeling is compliant with regulations for pharmaceutical and food products.

    Read More!
    9 Reasons Proofreading in Life Sciences Can Be a Nightmare

    October 2, 2023

    By: Marc Chaillou 3 minutes read

    9 Reasons Proofreading in Life Sciences Can Be a Nightmare

    Risks, stress and more – there’s a lot at stake when you proofread in regulated industries. Here are nine reasons why proofreading in life sciences can be a nightmare.

    Read More!
    The Importance of Braille Inspection on Packaging

    September 22, 2023

    By: Dean Halliday 4 minutes read

    The Importance of Braille Inspection on Packaging

    Inspecting Braille on packaging is important for compliance in the pharmaceutical industry. Automated proofreading supports you with Braille inspection.

    Read More!
    Top Medical Device use Document Comparison Software

    September 20, 2023

    By: Dean Halliday 4 minutes read

    Top Medical Device use Document Comparison Software

    When the subject of proofreading comes up, most think of correcting written text in a document such as a book or a school essay. In the Medical Device industry, however, proofreading is a whole lot more than that. Packaging and labeling can include many elements such as instructions for use, company logo, symbols and numerous other graphics, as well as a variety of different barcodes. Everything has a purpose and must be correct before a device goes to market.

    Read More!
    5 Must-Do Activities in Montreal During RAPS Convergence 2023

    September 18, 2023

    By: Peter Muller 2 minutes read

    5 Must-Do Activities in Montreal During RAPS Convergence 2023

    Welcome, esteemed professionals attending RAPS Convergence in Montreal! To help you experience the best of what Montreal has to offer, we've compiled a list of five must-do activities during your visit. Get ready to explore the charm and excitement of this captivating Canadian metropolis!

    Read More!
    Top Pharma use Document Comparison Software

    September 14, 2023

    By: Dean Halliday 4 minutes read

    Top Pharma use Document Comparison Software

    Top Pharma use document comparison software to proofread labeling. Why aren’t you? When the subject of proofreading comes up, most think of correcting written text in a document such as a book or a school essay. In the Pharma industry, however, proofreading is a whole lot more than that. Packaging and labeling include elements such ... Read more

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    A Short History of Regulatory Authorities

    August 17, 2023

    By: Mike Baird 4 minutes read

    A Short History of Regulatory Authorities

    Regulatory authorities are crucial for the safety and efficacy of medicines and medical devices. And yet, achieving the high level of regulation we have today has been a long road – with lives saved and lost along the way.

    Read More!
    A Guide to Medical Device Labeling Requirements

    August 17, 2023

    By: Vineed Ravindranath 4 minutes read

    A Guide to Medical Device Labeling Requirements

    Navigating complex labeling requirements for medical devices. Your guide to the fundamentals of regulation and compliance and how automated proofreading can minimize your labeling risks.

    Read More!
    Maximizing the benefits of e-labeling in Pharma and Med Device

    July 31, 2023

    By: Philipp Thomas 5 minutes read

    Maximizing the benefits of e-labeling in Pharma and Med Device

    With electronic labeling gaining momentum across healthcare markets, are you ready to maximize the benefits?

    Read More!
    Artwork Approval Processes for Pharma & Med Device

    July 31, 2023

    By: Dean Halliday 5 minutes read

    Artwork Approval Processes for Pharma & Med Device

    Improving artwork design and artwork approval processes can save patient lives and enhance company viability.

    Read More!
    5 Ways a Proofreading Software will Keep your Regulatory Affairs Team Happy

    June 28, 2023

    By: Vineed Ravindranath 2 minutes read

    5 Ways a Proofreading Software will Keep your Regulatory Affairs Team Happy

    Proofreading documents manually in regulatory affairs (RA) in the life sciences industry is stressful, high-risk and can lead to job dissatisfaction. The stakes are high – errors can harm patient health, result in product recalls, and damage brand and company reputations. Here’s how TVT, the proofreading software for regulatory affairs, can keep an RA team happy.

    Read More!
    Why Spelling Errors Can Be Lethal in Medical Packaging

    June 21, 2023

    By: Katarina Kresankova 4 minutes read

    Why Spelling Errors Can Be Lethal in Medical Packaging

    Spelling errors, missing information and language mistakes can lead to medical errors that put patient health at risk. Additionally, such errors can result in misprints, CAPA’s and product recalls.

    Read More!
    How to Reduce Drug Labeling Errors in Pharma

    May 26, 2023

    By: Katarina Kresankova 3 minutes read

    How to Reduce Drug Labeling Errors in Pharma

    FDA (US), EMA (EU), ANSM (France), CFDA (China), BfArM (Germany) – just to name a few of the national and international bodies that regulate the pharmaceutical industry. They share a common purpose: to ensure the patient safety and efficacy of medicines. And for this, they have regulatory procedures.

    Read More!
    Regulatory Guidelines for Labeling in Pharma

    May 23, 2023

    By: Peter Muller 5 minutes read

    Regulatory Guidelines for Labeling in Pharma

    Pharmaceutical labeling is a critical element of healthcare products and services that are strictly regulated by health authorities. This includes the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe. The FDA oversees the safety and efficacy of pharmaceutical drugs, biopharmaceuticals, and other healthcare products. As a result, pharmaceutical labeling is a complex and meticulous process, with even minor errors resulting in significant consequences.

    Read More!
    Regulatory Affairs – Partnering for Knowledge

    May 8, 2023

    By: Peter Muller 2 minutes read

    Regulatory Affairs – Partnering for Knowledge

    As a company that was built around a specific need for Regulatory Affairs (RA), we must also remain on top of regulatory developments. Ensuring our software continues to meet the needs of RA professionals. Our top resource is RAPS, the Regulatory Affairs Professionals Society and in this article we look at our partnership with RAPS and the importance of this organization.  

    Read More!
    Why is labeling important in the pharmaceutical industry?

    May 3, 2023

    By: Dean Halliday 4 minutes read

    Why is labeling important in the pharmaceutical industry?

    Bringing a new drug to market demands a large investment on the part of a pharmaceutical company – often, $ 1 billion or more. Ensuring compliance with complex labeling regulations is part of that investment. In the following we look at why pharmaceutical labeling is so important and the different types of labeling.

    Read More!
    What is Document Comparison Software For Regulatory Affairs?

    March 15, 2023

    By: Philipp Thomas 5 minutes read

    What is Document Comparison Software For Regulatory Affairs?

    The major players in the Pharma and Medical Devices industries have either adopted or are in the process of adopting a software for document comparison. Like other technologies, this too has been a slow adoption despite it’s proven time, money, and stress savings. The goal of this article is to explain how document comparison software can help and why it is an essential part of any Regulatory Affairs tech stack.

    Read More!
    E-Labelling: Practical Next Steps for Medical Device Manufacturers

    March 6, 2023

    4 minutes read

    E-Labelling: Practical Next Steps for Medical Device Manufacturers

    Practical next steps for medical device manufacturers & distributors as regulators demand the digital delivery of customer-facing product information in place of paper inserts.

    Read More!
    8 Ways RA can help get Products to Market Faster

    March 2, 2023

    By: Philipp Thomas 5 minutes read

    8 Ways RA can help get Products to Market Faster

    Bringing a new drug to market is time-consuming and costly, and generally takes 10 years and costs over $1 billion. The smallest lapse in labeling and packaging can jeopardize even the most well-planned submission. A proofreading and comparison software can help you get there faster, safer.

    Read More!
    5 Ways You’re Wasting Time & Money in Regulatory Affairs

    March 1, 2023

    By: Dean Halliday 5 minutes read

    5 Ways You’re Wasting Time & Money in Regulatory Affairs

    If you are proofreading manually, you are aware of how time-consuming it is. We have all heard the saying “time is money”, and this is very true for Regulatory Affairs professionals. In this article, we'll be exploring proofreading in Regulatory Affairs, and 5 ways that RA depts. are wasting money by relying on manual proofreading.

    Read More!
    13 Questions to Ask When Choosing Comparison Software

    February 2, 2023

    By: Peter Muller 4 minutes read

    13 Questions to Ask When Choosing Comparison Software

    Settling on a text comparison solution that does not require you to change your existing processes can be a daunting task, but we are here to help! We’ve outlined 13 questions for you to ask before making your final choice.

    Read More!
    11 Ways Proofreading Is Easier with TVT 11

    November 10, 2022

    By: Mike Baird 3 minutes read

    11 Ways Proofreading Is Easier with TVT 11

    Using a proofreading software like TVT®, takes the stress out of proofreading by automating tasks.

    Read More!
    How to Attract and Retain Regulatory Affairs Professionals

    September 20, 2022

    By: Katarina Kresankova 4 minutes read

    How to Attract and Retain Regulatory Affairs Professionals

    As we move through 2022, Human Resource (HR) departments and recruiters are looking at the impact of the Great Resignation on regulatory affairs. The current trend to job switching, the “Great Resignation”, may be flattening out in some professions in mid-2022, but the difficulty of attracting and retaining top talent in regulatory affairs remains an ongoing challenge for pharmaceutical companies, and the stakes are high.

    Read More!
    10  Automated Proofreading Benefits that Make Your Life Easier

    September 8, 2022

    By: Philipp Thomas 4 minutes read

    10 Automated Proofreading Benefits that Make Your Life Easier

    Whether you proofread labeling and packaging full-time, or proofreading is just one of your many tasks in your working day, automated proofreading with TVT, the Text Verification Tool©, will make your life easier.

    Read More!
    Barocde Compliance: 3 Rules for Barcodes in Life Sciences

    August 10, 2022

    By: Mike Baird 2 minutes read

    Barocde Compliance: 3 Rules for Barcodes in Life Sciences

    Optimize barcode scanning precision in pharmaceutical, artwork, quality control, packaging, and printing industries with these indispensable tips. Avoid delays and errors for smooth workflow.

    Read More!
    Top Pharma Companies Automate Proofreading

    July 15, 2022

    By: Dean Halliday 3 minutes read

    Top Pharma Companies Automate Proofreading

    Top pharma companies automate proofreading with TVT. Read all top 10 reasons.

    Read More!
    Are You Struggling to Proofread Foreign Languages or Braille?

    June 21, 2022

    By: Philipp Thomas 4 minutes read

    Are You Struggling to Proofread Foreign Languages or Braille?

    “A different language is a different vision of life,” said the Italian film director, Federico Fellini.

    Read More!
    Manual vs Automated Proofreading

    June 10, 2022

    By: Philipp Thomas 3 minutes read

    Manual vs Automated Proofreading

    When was the last time you flew in a passenger jet? Would you have felt as safe if the jet didn’t have automated controls? These relieve pilots of repetitive actions, reducing the risk of error and allowing pilots to focus on broader tasks related to safety and operation.

    Read More!
    Why Data Integrity is Important in Pharma

    May 20, 2022

    By: Dr. Jutta Hohenhoerst 3 minutes read

    Why Data Integrity is Important in Pharma

    Learn about Data Integrity and its crucial role in maintaining valuable data for various stakeholders, including patients, communities, and companies, through ALCOA and ALCOA+ principles.

    Read More!
    The True Cost of Manual Proofreading in Regulated Industries

    May 17, 2022

    By: Katarina Kresankova 3 minutes read

    The True Cost of Manual Proofreading in Regulated Industries

    Looking for more information on how you can improve your team’s proofreading practices? Learn how Lohmann & Rauscher reduced the number of correction cycles and gained significant time back by implementing TVT in their proofreading process.

    Read More!
    8 Secrets Proofreaders Don’t Want to Reveal

    March 25, 2022

    By: Marc Chaillou 3 minutes read

    8 Secrets Proofreaders Don’t Want to Reveal

    First, by proofreading, we mean text comparison of 2 files, like a manuscript versus a laid-out artwork of what should be the same text, not content correction of a single text. Over the years, many proofreaders have shared with us what manual text comparison really means for them. When they try to convince their boss to invest in electronic text comparison software, they usually present the business reasons, discussing ROI, risk avoidance, improved quality, time savings and so on.

    Read More!
    The Story Behind the Name | Schlafender Hase

    March 9, 2022

    By: Schlafender Hase 2 minutes read

    The Story Behind the Name | Schlafender Hase

    Ask Frank Hessler, founding CEO of Schlafender Hase, how the company name “Sleeping Rabbit” came about and a wry smile crosses his face. "We're sometimes asked this by customers, and to be honest, it's a simple story. It dates back to the early 2000s when we used a code name to talk about the company. I know it's usual to have a generic code name like "New Company", but we were different. The inspiration was a fluffy toy hanging on a rear vision mirror of a friend's car. We found this amusing, and somehow this fluffy rabbit just established itself. We used it so often that the name stuck.”

    Read More!
    What Bill Murray and Text Comparison Have in Common

    February 21, 2022

    By: Marc Chaillou 2 minutes read

    What Bill Murray and Text Comparison Have in Common

    Ready to put an end to repetitive correction cycles?

    Read More!
    Laser-focused on Digital Workflows in the Era of Pharma 4.0

    January 4, 2022

    By: Mike Baird 4 minutes read

    Laser-focused on Digital Workflows in the Era of Pharma 4.0

    Pharma 4.0 is changing the landscape of the pharmaceutical industry, with a similar quiet revolution also taking place in proofreading through automation and transparency. This is illustrated by the enhancements in the new Version 10.2 of TVT®.

    Read More!
    Reduce Labeling Errors in Your Artwork

    December 21, 2021

    By: Mike Baird 12 minutes read

    Reduce Labeling Errors in Your Artwork

    Over the years, as we’ve worked to help make proofreading easier and more accurate for our customers, we’ve witnessed many different types of potential issues with labeling artwork design proofs. Most of these issues are visible to the human eye when reading through the document, but a few of them are invisible and require special techniques.

    Read More!
    Understanding Unicode for Proofreaders

    November 17, 2021

    By: Marc Chaillou 4 minutes read

    Understanding Unicode for Proofreaders

    Unicode is a computer and software industry standard for handling text. While it is possible to geek-out on the technical aspects of Unicode (and if you’re so inclined you can check out the Wikipedia page on Unicode and the Unicode Consortium website), in this article we’re going to focus more on understanding the fundamentals, and discuss why this basic knowledge is critical for anyone who is part of a document creation / editing / review / correction workflow in a highly regulated industry.

    Read More!
    10 Historically Expensive Recalls in Pharma

    November 12, 2021

    By: Vineed Ravindranath 3 minutes read

    10 Historically Expensive Recalls in Pharma

    Curious about the history of pharmaceutical recalls and the billions of dollars lost?  Please see below for 10 pricey issues and the health risks associated behind the reason for the recalls.

    Read More!
    Live vs. Rasterized vs. Vectorized Text

    October 20, 2021

    By: Marc Chaillou 4 minutes read

    Live vs. Rasterized vs. Vectorized Text

    In a previous post, we covered the basics of Unicode and why it’s so important for proofreaders (or anyone involved in the document creation, review and correction workflow) to understand the differences between the way humans and computers read language. Today, we’ll build on that knowledge as we examine different ways design and print proofs can be exported to PDF and the risks associated with removing live text from your organization’s documents.

    Read More!
    Common Labeling Errors That  Lead to Pharmaceutical Recalls

    October 12, 2021

    By: Marc Chaillou 4 minutes read

    Common Labeling Errors That Lead to Pharmaceutical Recalls

    Explore the impact of labeling errors on pharmaceutical recalls. Find out how to avoid these mistakes and maintain compliance with industry regulations.

    Read More!
    MDR e-Labeling

    October 6, 2021

    By: Marc Chaillou 2 minutes read

    MDR e-Labeling

    The EU Medical Device Regulations (MDR) states any device manufacturer with a website must publish user information in electronic form.

    Read More!
    MDR Graphic Symbols

    October 6, 2021

    By: Marc Chaillou 2 minutes read

    MDR Graphic Symbols

    Over the last few posts, we have been touching upon different labelling requirements set by the MDR.

    Read More!
    Medical Devices Regulation EU 2017/745

    September 30, 2021

    By: Mike Baird 2 minutes read

    Medical Devices Regulation EU 2017/745

    Medical Devices Regulation (MDR) updates represent a step towards higher labeling standards.

    Read More!
    MDR UDI and Device Registration

    September 22, 2021

    By: Marc Chaillou 2 minutes read

    MDR UDI and Device Registration

    The new European Database on Medical Devices, known as EUDAMED, was originally scheduled to launch in May 2020,

    Read More!
    Top 3 reasons to encourage your employees to participate in e-Learning

    September 6, 2021

    By: Dr. Jutta Hohenhoerst 3 minutes read

    Top 3 reasons to encourage your employees to participate in e-Learning

    As part of our TVT e-Learning portal we are offering a free trial to anyone interested in getting a feel for the system.

    Read More!
    Top 8 Reasons for Mistakes in Your PDF Artwork

    August 25, 2021

    By: Philipp Thomas 3 minutes read

    Top 8 Reasons for Mistakes in Your PDF Artwork

    As you can see, the way in which the graphic designer / typesetter works as well as the tools and processes they use will influence the quality and content of the PDF Artwork.

    Read More!
    Make Sure Your Barcode Makes the Grade

    August 11, 2021

    By: Mike Baird 4 minutes read

    Make Sure Your Barcode Makes the Grade

    In this interview, Mike Baird talks about TVT Barcode and what TVT customers can expect from this new module and the newly released version 10.2 of TVT, the Text Verification Tool.

    Read More!
    Four Tips for Regulatory Affairs to Proofread Braille

    July 15, 2021

    By: Marc Chaillou 3 minutes read

    Four Tips for Regulatory Affairs to Proofread Braille

    If you are part of a Labelling, Packaging, Graphics or Regulatory Affairs Department, these four tips will save time, and reduce risk and stress due to a missed error – even if you don’t have access to software capable of reading Braille. Since some European regulatory bodies mandate important information such as product name and dosage be written in Braille on packaging, knowing how to ensure Braille accuracy will be an asset for you and your specific life sciences company.

    Read More!
    Enhancing Your Workflow with Mike Baird

    June 17, 2021

    By: Mike Baird 4 minutes read

    Enhancing Your Workflow with Mike Baird

    Mike Baird, Director of Product Management at Schlafender Hase responds to user questions.

    Read More!
    TVT Critical Word List Finds Common Proofreading Mistakes in Original Documents

    June 2, 2021

    By: Dr. Jutta Hohenhoerst 2 minutes read

    TVT Critical Word List Finds Common Proofreading Mistakes in Original Documents

    by: Schlafender Hase

    Read More!
    O.K., So You Must Do a Manual Proofread?

    May 3, 2021

    By: Marc Chaillou 2 minutes read

    O.K., So You Must Do a Manual Proofread?

    The meaning of O.K. stems from the words “all correct”, spelled incorrectly.

    Read More!
    Risks of Converting Documents in the Pharmaceutical Industry

    April 22, 2021

    By: Marc Chaillou 2 minutes read

    Risks of Converting Documents in the Pharmaceutical Industry

    Discover the dangers involved in converting documents within the pharmaceutical sector. Find valuable insights and strategies to address these risks in our article.

    Read More!
    The EMA and TVT

    March 16, 2021

    By: Marc Chaillou 2 minutes read

    The EMA and TVT

    Hey! Regulatory affairs professionals! The European Medicines Agency (EMA) has been using TVT, the Text Verification Tool® since 2004!

    Read More!
    Future-Proof Your Regulatory Submissions – Increasing Efficiency and Quality With Information Management Systems

    February 16, 2021

    By: Peter Muller 3 minutes read

    Future-Proof Your Regulatory Submissions – Increasing Efficiency and Quality With Information Management Systems

    Information and data management is an integral part of regulatory compliance across the globe, particularly in the highly regulated pharmaceuticals and medical device industries. These systems support industry by providing highly specialized as well as essential services. Companies benefit from these by being able to develop harmonious strategies and systems that evolve as regulations change. Whether you are currently using information management systems or just setting out, there are some key aspects you need to consider if you want to get it right. This will also be the topic of an upcoming webinar on 23 February 2021.

    Read More!
    The Art of Listening

    December 15, 2020

    By: Katarina Kresankova 4 minutes read

    The Art of Listening

    The year ends, even a year as difficult as 2020. At the end you look back, you look ahead. In comparison, making a Christmas list is easy.

    Read More!
    TVT Connect works with Your Information Management System

    November 17, 2020

    By: Mike Baird 3 minutes read

    TVT Connect works with Your Information Management System

    If you would like to know more about TVT Connect and integration with information management systems, contact us:

    Read More!
    How to Compare Excel Files: To Improve your Proofreading Workflow

    October 8, 2020

    By: Marc Chaillou 3 minutes read

    How to Compare Excel Files: To Improve your Proofreading Workflow

    Yes, this can be a common situation: a Brand Owner submits the packaging or labeling brief in multiple file formats using an Excel spreadsheet combined with a Word document. Critical, legally required table information such as nutrition facts and allergens arrive in Excel templates. These Excel files are used to generate label revisions which comply with FDA regulations.

    Read More!
    The Rabbit Rebrand

    October 1, 2019

    By: Schlafender Hase 5 minutes read

    The Rabbit Rebrand

    Schlafender Hase’s proofreading software, TVT®, the Text Verification Tool®, has been catching errors on packaging and labels of life sciences products for 15 years now. CEO Frank Hessler and Head of Marketing, Kindrie Eaton take a look at the company’s past with a view toward its future and their rebrand.

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    Are You a Medical Device Manufacturer?

    July 25, 2019

    By: Dr. Jutta Hohenhoerst 4 minutes read

    Are You a Medical Device Manufacturer?

    The regulation on medical devices 2017/745, widely known as the EU MDR, was released in May 2017 with regulation 2017/746 on in vitro diagnostics. EU MDR and regulation 2017/746 replaced Council Directive 93/42/EEC, also known as the Medical Device Directive (MDD), and Directive 98/79/EC on in vitro diagnostic medical devices.

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    Medical Device Recalls

    June 13, 2018

    By: Peter Muller < 1 minute read

    Medical Device Recalls

    The majority of medical device recalls are due to labeling or software - HMI issues. TVT can help keep you from becoming a statistic.

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    2 Biggest Myths in Electronic Proofreading

    August 17, 2015

    By: Marc Chaillou < 1 minute read

    2 Biggest Myths in Electronic Proofreading

    Below are what I consider as the top 2 biggest misunderstandings regarding electronic proofreading.

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September 27, 2024

Schlafender Hase Team

Understanding Document Comparison Software: A Key Tool for Regulatory Affairs in Crop Science

Much like in the pharmaceutical and medical device sectors, where the adoption of such software has proven to reduce workloads and the risk of errors that may cause recalls or stop-sales, the Crop Science industry is also beginning to recognize the value of integrating this technology.

4 minutes read

Understanding Document Comparison Software: A Key Tool for Regulatory Affairs in Crop Science

Much like in the pharmaceutical and medical device sectors, where the adoption of such software has proven to reduce workloads and the risk of errors that may cause recalls or stop-sales, the Crop Science industry is also beginning to recognize the value of integrating this technology.

September 9, 2024

Schlafender Hase Team

Rising regulatory demands: are medical device suppliers ready?

The global medical devices market is set to reach $886.80 billion in value by 2032 . As devices become more critical to patient outcomes, regulators’ quality and safety expectations and associated controls are increasing.

3 minutes read

Rising regulatory demands: are medical device suppliers ready?

The global medical devices market is set to reach $886.80 billion in value by 2032 . As devices become more critical to patient outcomes, regulators’ quality and safety expectations and associated controls are increasing.

August 22, 2024

Schlafender Hase Team

FHIR: Transforming Product Labeling

The shift from paper-based to digital processes has opened enormous opportunities in the healthcare sector in terms of data sharing and content management. But data can only be shared efficiently and add value if systems can "talk" to each other. The term we use for how compatibly systems work together is "interoperability." Traditionally, the healthcare sector has suffered from a high lack of interoperability.

6 minutes read

FHIR: Transforming Product Labeling

The shift from paper-based to digital processes has opened enormous opportunities in the healthcare sector in terms of data sharing and content management. But data can only be shared efficiently and add value if systems can "talk" to each other. The term we use for how compatibly systems work together is "interoperability." Traditionally, the healthcare sector has suffered from a high lack of interoperability.

August 15, 2024

Schlafender Hase Team

Empowering Pharma and Regulatory Frameworks with Structured Content

Structured content ensures compliance in the pharmaceutical industry. Discover how FDA’s SPL and Canada’s SPM formats promote patient safety and efficiency.

5 minutes read

Empowering Pharma and Regulatory Frameworks with Structured Content

Structured content ensures compliance in the pharmaceutical industry. Discover how FDA’s SPL and Canada’s SPM formats promote patient safety and efficiency.

August 9, 2024

Schlafender Hase Team

The Importance of Structured Content in Product Labeling

In the first of a three-part series on structured content and structured product labeling, we explore why structured content is important, its benefits, and best practices for implementation.

4 minutes read

The Importance of Structured Content in Product Labeling

In the first of a three-part series on structured content and structured product labeling, we explore why structured content is important, its benefits, and best practices for implementation.

August 8, 2024

Schlafender Hase Team

The Critical Impact of Labeling Errors in the Pharmaceutical Industry

In the complex landscape of pharmaceutical manufacturing, every detail matters. From the formulation of the drug to its packaging and labeling, precision is vital. However, despite stringent regulations and quality control measures, labeling errors persist, posing significant risks to patient safety and public health.

2 minutes read

The Critical Impact of Labeling Errors in the Pharmaceutical Industry

In the complex landscape of pharmaceutical manufacturing, every detail matters. From the formulation of the drug to its packaging and labeling, precision is vital. However, despite stringent regulations and quality control measures, labeling errors persist, posing significant risks to patient safety and public health.

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