Data Integrity Final Guidance


FDA has issued the Data Integrity and Compliance with Drug cGMP final guidance on December 13, 2018.  The final guidance is available at the following link.

As stated in the Introduction section of the guidance:

FDA expects that all data be reliable and accurate (see the “Background” section). CGMP regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. Firms should implement meaningful and effective strategies to manage their data
integrity risks based on their process understanding and knowledge management of technologies and business models.

A review of warning letters has identified a number of inspectional findings on Data Integrity.  As stated in the Background section – In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, and of FDA’s ability to protect the public health.  These data integrity-related CGMP violations have led to numerous regulatory actions, including
warning letters, import alerts, and consent decrees.

As identified in the Federal Register, the final guidance has been revised based on industry comments provided on the 2016 draft, and includes clarifying language and additional examples on current best practices and additional examples.

Performance Validation has performed several data integrity projects, and has posted a recently completed project project summary which is available for your review.  Have questions on data integrity?  Please feel free to use our Contact Us form for additional information.

Rick