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.
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!
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.
