Managing Data Integrity in GCP Environments

This week on Voices in Validation we invite Chris Wubbolt back to provide an overview on best practices for managing data integrity expectations in Good Clinical Practice environments. The discussion will include current guidelines that apply to Data Integrity, the most important data integrity issues, the need for original documents for investigations, what good SOP’s include and in detail for firms to manage data risks, specific regulations for eRecords and eSignatures, plus the use of electronic documents for data integrity. Also referenced are specific case studies and examples from an auditors perspective.

Documents referenced include:

• Investigations Operations Manual  2020 - https://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM607759.pdf
• Guide to Inspections of Pharmaceutical Quality Control Laboratories - https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/pharmaceutical-quality-control-labs-793
• Guidances and Manuals on Pharmaceutical Quality - https://www.fda.gov/drugs/pharmaceutical-quality-resources/guidances-and-manuals-pharmaceutical-quality
• MHRA Guidance - Good clinical practice for clinical trials - https://www.gov.uk/guidance/good-clinical-practice-for-clinical-trials
• MHRA Inspection Toolkit - http://www.ct-toolkit.ac.uk/routemap/mhra-inspection/
• MHRA Inspectorate Computer System Validation – GCP - https://mhrainspectorate.blog.gov.uk/2017/04/20/computer-system-validation-gcp/E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)
• FDA Guidance Docs - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r2-good-clinical-practice-integrated-addendum-ich-e6r1