September 18, 2023
Schlafender Hase Team
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!
August 17, 2023
Schlafender Hase Team
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.
August 17, 2023
Schlafender Hase Team
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.
July 31, 2023
Schlafender Hase Team
With electronic labeling gaining momentum across healthcare markets, are you ready to maximize the benefits?
July 31, 2023
Schlafender Hase Team
Improving artwork design and artwork approval processes can save patient lives and enhance company viability.
June 28, 2023
Schlafender Hase Team
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.
June 21, 2023
Schlafender Hase Team
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.
May 26, 2023
Schlafender Hase Team
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.
May 23, 2023
Schlafender Hase Team
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.
May 8, 2023
Schlafender Hase Team
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.
May 3, 2023
Schlafender Hase Team
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.
March 15, 2023
Schlafender Hase Team
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.
March 2, 2023
Schlafender Hase Team
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.
March 1, 2023
Schlafender Hase Team
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.
February 2, 2023
Schlafender Hase Team
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.
January 6, 2023
Schlafender Hase Team
Operationally and reputationally, creators and suppliers of medical devices have much to gain by embracing electronic labelling (e-labelling) at their earliest opportunity. The potential benefits will span the whole business.
November 10, 2022
Schlafender Hase Team
Using a proofreading software like TVT®, takes the stress out of proofreading by automating tasks.
September 20, 2022
Schlafender Hase Team
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.
September 8, 2022
Schlafender Hase Team
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.
August 10, 2022
Schlafender Hase Team
They are almost everywhere in our lives today, roaming far and wide, and yet as consumers we hardly notice them. We know them best in retail but we also find them in transport and logistics to track deliveries, in healthcare for labelling and packaging, and virtually everywhere else in our world.
July 15, 2022
Schlafender Hase Team
Top pharma companies automate proofreading with TVT. Read all top 10 reasons.
June 21, 2022
Schlafender Hase Team
“A different language is a different vision of life,” said the Italian film director, Federico Fellini.
June 10, 2022
Schlafender Hase Team
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.
May 20, 2022
Schlafender Hase Team
It is important that these fundamental ALCOA+ principles be implemented across a company and throughout the whole lifecycle of a product.
May 17, 2022
Schlafender Hase Team
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.
March 25, 2022
Schlafender Hase Team
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.
March 9, 2022
Schlafender Hase Team
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.”
February 21, 2022
Schlafender Hase Team
Ready to put an end to repetitive correction cycles?
January 4, 2022
Schlafender Hase Team
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®.
December 21, 2021
Schlafender Hase Team
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.
November 17, 2021
Schlafender Hase Team
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.
November 12, 2021
Schlafender Hase Team
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.
October 20, 2021
Schlafender Hase Team
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.
October 12, 2021
Schlafender Hase Team
Proofreaders are “the air traffic controllers of pharmaceutical labeling and packaging,” says Dr. Jutta Hohenhoerst, Regional Sales Director, Schlafender Hase. “They have to get it right, because the consequences can be far-reaching.”
October 6, 2021
Schlafender Hase Team
The EU Medical Device Regulations (MDR) states any device manufacturer with a website must publish user information in electronic form.
October 6, 2021
Schlafender Hase Team
Over the last few posts, we have been touching upon different labelling requirements set by the MDR.
September 30, 2021
Schlafender Hase Team
Medical Devices Regulation (MDR) updates represent a step towards higher labeling standards.
September 22, 2021
Schlafender Hase Team
The new European Database on Medical Devices, known as EUDAMED, was originally scheduled to launch in May 2020,
September 6, 2021
Schlafender Hase Team
As part of our TVT e-Learning portal we are offering a free trial to anyone interested in getting a feel for the system.
August 25, 2021
Schlafender Hase Team
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.
August 11, 2021
Schlafender Hase Team
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.
July 15, 2021
Schlafender Hase Team
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.
June 17, 2021
Schlafender Hase Team
Mike Baird, Director of Product Management at Schlafender Hase responds to user questions.
June 2, 2021
Schlafender Hase Team
by: Schlafender Hase
May 3, 2021
Schlafender Hase Team
The meaning of O.K. stems from the words “all correct”, spelled incorrectly.
April 22, 2021
Schlafender Hase Team
Data integrity. These are two words that are not easily confused or misinterpreted. In any context, across continents, data integrity holds one meaning. That meaning lies in what the finalized document or work communicates and if this communication remains in an unaltered form over time.
March 16, 2021
Schlafender Hase Team
This may come as a surprise to regulatory affairs professionals of the pharmaceutical industry, but the European Medicines Agency (EMA) has been using TVT, the Text Verification Tool® since 2004!
February 16, 2021
Schlafender Hase Team
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.
December 15, 2020
Schlafender Hase Team
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.
November 17, 2020
Schlafender Hase Team
If you would like to know more about TVT Connect and integration with information management systems, contact us:
October 8, 2020
Schlafender Hase Team
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.
October 1, 2019
Schlafender Hase Team
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.
July 25, 2019
Schlafender Hase Team
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.
June 13, 2018
Schlafender Hase Team
The majority of medical device recalls are due to labeling or software - HMI issues. TVT can help keep you from becoming a statistic.
August 17, 2015
Schlafender Hase Team
Below are what I consider as the top 2 biggest misunderstandings regarding electronic proofreading.
