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Converting documents

April 22, 2021

Schlafender Hase Team

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.

Converting documents
  • 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.

EMA uses TVT

March 16, 2021

Schlafender Hase Team

The EMA and TVT

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

EMA uses 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!

Regulatory Submissions

February 16, 2021

Schlafender Hase Team

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.

Regulatory Submissions
  • 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.

December 15, 2020

Schlafender Hase Team

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.

  • 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.

TVT Connect and my Information Management System

November 17, 2020

Schlafender Hase Team

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:

TVT Connect and my 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:

How to Compare Excel Files

October 8, 2020

Schlafender Hase Team

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.

How to Compare Excel Files
  • 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.

The TVT Rabbit

October 1, 2019

Schlafender Hase Team

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.

The TVT Rabbit
  • 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.

Medical Device Manufacturer

July 25, 2019

Schlafender Hase Team

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.

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.

Medical Device Recalls

June 13, 2018

Schlafender Hase Team

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.

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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