Managing data integrity in GCP environment

Stacey Bruzzese welcomes back Chris Wubbolt, Principal of QACV Consulting, to the show. Today, Stacey and Chris will be discussing how to manage data integrity expectations in GCP environment.

Current guidelines that apply to Data Integrity
What are the most important data integrity issues?
The need for original documents for investigations
What should SOP’s entail for firms to manage data risks?
Specific regulations for eRecords and eSignatures
Use of electronic documents for data integrity
What have companies gone through during an audit of this type?

 

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) - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r2-good-clinical-practice-integrated-addendum-ich-e6r1

 

Chris has over 25 years’ experience in regulated industry and has provided compliance, quality assurance and computer validation consulting services. He remains current in industry trends and requirements and frequently speaks or provides workshops at leading industry conferences and programs. Chris has a master’s Degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering, along with a Six Sigma Black Belt Certification.

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