Background

Data Integrity is a global problem and currently a major concern with FDA and European Regulatory Agencies.

As the regulators are tightening their inspection approaches it is important that managers, supervisors and users in regulated GMP laboratories understand the issues around data integrity and begin programs to ensure that their processes and systems are robust.

Objectives

• Understand the current FDA and EU GMP regulations and guidance impacting data integrity from paper records to hybrid and electronic systems.
• Understand the FDA requirements for data integrity, MHRA Data Integrity guidance July 2016 and WHO guidance from September 2015.
• Learn what is required for a data governance system from senior management through to staff in laboratories, manufacturing and quality assurance.
• Understand the data life cycle and how it is linked with the business process and where problems can occur for both paper records, hybrid systems and electronic systems.