ECA Data Integrity Task Force issues Version 2.0 of Data Integrity Guide

With data integrity issues increasingly moving into the centre of attention of international authorities, the ECA's Analytical Quality Control Working Group and the IT Compliance Interest Group joined forces in a Task Force in 2016 to work on a new guide on data governance and data integrity. Version 1.0 was issued later that year.

Now the Task Force completed its revision of the Guide and issued version 2.0. This new version is a comprehensive rework of the Guide. It comprises many examples for implementing data integrity practically and covers the following scope:

1. Definition of data governance in the GMP area as a set of policies and procedures within a Pharmaceutical Quality Management System which leads to ensuring data integrity and data security within an ethical corporate culture
2. Providing a single source of clear and concise harmonised high level guidance document covering data governance and data integrity with regard to corporate, laboratory, production and IT activities within the framework of a Pharmaceutical Quality Management System
3. Review and evaluation of regulatory requirements and guidelines to work towards global harmonisation and compliance
4. Providing a model framework to achieve objectives 1 through 3
5. Providing more detailed appendices for specific data integrity topics

The new version takes into account the requirements of the latest regulatory initiatives - like the

  • UK MHRA GMP Data Integrity Initiatives
  • Draft MHRA GxP Data Integrity Guidance for Industry
  • WHO Guidance on Good Data and Records Management Practices
  • FDA Draft Guidance on Data Integrity and Compliance with CGMP, and the
  • PIC/S PI-041 Data Integrity Guidance

Members of the Task Force are Dr Bob McDowall, Dr Wolfgang Schumacher and Dr Chris Burgess as well as Stefan Schöttle, Margarita Sabater and Dr Markus Dathe.

The new Guide will be distributed free of charge to all participants of ECA courses and conferences on data integrity.