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.

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.

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.

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

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.

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.

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.

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.

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

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.

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?

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.

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.

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.

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

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.”

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

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

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

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).

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

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.

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.

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

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.

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!

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

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.

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.

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

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

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.

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.

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.

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.

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.  

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.

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.

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

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.

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.

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.

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

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.

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.

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

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

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

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.

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.

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.

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.

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.”

Ready to put an end to repetitive correction cycles?

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®.

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.

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.

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.

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.

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

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

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

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

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

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

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.

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.

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.

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

by: Schlafender Hase

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

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

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

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.

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.

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

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.

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.

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.

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

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