Voices In Validation artwork

Top Five Data Integrity Issues

Voices In Validation

English - October 12, 2021 04:00 - 48 minutes - 38.6 MB - ★★★★★ - 8 ratings
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This week, Stacey and industry expert, Chris Wubbolt, count down the top five data integrity issues when complying with GMP guidance. Data Integrity is a critical element to GMP compliance, and all life science manufacturers need to develop and maintain processes for managing their data, reducing the risk to the integrity of that data, and stored properly. Of course, this is all part of the Regulatory Guidelines which have been in place for years. Still, nearly half of all warning letters contain data integrity components.


Resources for this Episode:


Data Integrity and Compliance with cGMP Guidance


Guideline on data integrity - WHO | World Health Organization


Part 11, Electronic Records; Electronic Signatures - Scope and Application


About Our Guest:


Chris Wubbolt, Principal, QACV Consulting


Chris has over 25 years of experience in the 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.


Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.