Data Integrity has become one of the most frequently observed GMP deviations at FDA and EU Inspections. This is why the topic is currently in the centre of attention of both regulators and industry. And for that reason the ECA Foundation decided to set up a Task Force on Data Integrity in December 2015 - with the goal to provide Guidance for the implementation in practice.
The ECA Task Force will be comprised of members from both the IT Compliance Group and the Analytical QC Group. Current Members are:
- Dr. Wolfgang Schumacher, Hoffmann-La Roche, Switzerland
- Dr. Chris Burgess, Qualified Person and Consultant, UK
- Dr. Bob McDowall, Consultant, UK
- Ms. Margarita Sabater, ALK-Abelló A/S, Denmark
The Task Force decided to develop a Guidance entitled: "Data Governance and Data Integrity for GMP Regulated Facilities". The ECA Guidance Document will cover - among others - the Roles and Responsibilities of Corporate and Senior Management in Data Governance as well as the necessary Policies, Procedures and Processes. Further information is provided on establishing criteria for Data Integrity and security of records based on ALCOA+Principles and on Auditing for Data Integrity and security of records.
The Guide will contain a Glossary as well as some illustrative appendices for further information.
Margarita Sabater, Member of the ECA Task Force, will present the Draft Version of the ECA Data Integrity Guidance Document during the Lab Data Integrity Conference on 20-21 October 2016 in Vienna, Austria. Every participant will receive a copy of the Draft Document - and is also invited to provide feedback to the Guidance Document.