What are the GMP Requirements for Data Integrity?

Data integrity for pharmaceutical GMP operations remains a focus for global regulators. Many agencies have released guidances and other documents covering GMP requirements concerning data integrity.

To help you stay on top of the latest regulatory thinking on data integrity, we have curated the following content:

• FDA Regulators Address Data Integrity and Lab Audit Trails
  During a panel at the 2021 PDA/FDA Joint Regulatory Conference, FDA regulators identified data integrity concerns involving analytical instruments.
• What Can Regulatory Data Tell Us About Data Integrity Trends?
  Redica Systems Senior GMP Quality Expert Jerry Chapman takes a deep dive into five years’ worth of FDA Warning Letters to find data integrity citations “hiding in plain sight.”
• Synergy at the Intersection of Data Integrity and Quality Culture
  Find out how companies can take a synergistic approach to improving both data integrity and quality culture.
• Data Integrity Concerns Discovered in Gene Therapy Product Submissions
  Check out three case studies involving FDA concerns about potential data integrity issues in drug applications.
• How to Identify Data Integrity (and Other) Trends
  Learn more about the specific data integrity issues data show FDA is most concerned about.
• Data Integrity 101: Why is it Important?
  Build your knowledge about data integrity, from the language FDA uses to the potential consequences of poor data integrity practices.

[Related: Data integrity is one of four topics explored in our latest FREE report, “The Current Pharmaceutical Quality Landscape.”]