Chris Clark

TenTenTen Consulting Limited
Director
Chris is Director and Consultant of TenTenTen Consulting Limited, providing advice and direct support to overcome the business and regulatory challenges to patient safety, product quality and data integrity. With over 40 years’ experience of Quality Control / Quality Assurance covering various GxP pharmaceutical fields, he has specialized experience in ensuring compliance of a wide range of computerized systems (Laboratory systems, MRP systems, Documentation Management systems, Clinical systems). As Chair of the GAMP® Editorial Board and a member of both the ISPE GAMP® Global Steering Committee and GAMP® Europe Steering Committee, he has contributed and supported the publication of several GAMP® Guidance documents, most notably the original and second edition of ISPE’s GAMP® 5 Guide A Risk-Based Approach to Compliant GxP Computerized Systems. Additionally, Chris is currently Interim Co-Chair of the ISPE Guidance Documents Committee. He has been an ISPE member since 1997.

Related Articles

What You Need to Know About GAMP® 5 Guide, 2nd Edition
Features
What You Need to Know About GAMP® 5 Guide, 2nd Edition

ISPE’s GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) (GAMP® 5 Guide, 2nd Edition) maintains the principles and framework of the first edition and updates their application in the modern world, including the increased importance of service providers, evolving approaches to software development, and expanded use of software tools and...

GAMP® 5 Second Edition is Here!
iSpeak Blog
GAMP® 5 Second Edition is Here!

GAMP® 5 Second Edition is here! Since its publication, GAMP® 5 has been far and away the leading international guidance on GxP computerized systems validation and compliance, and it was time to update our guidance to...

Why ISPE GAMP® Supports the FDA CDRH: Case for Quality Program
Features
Why ISPE GAMP® Supports the FDA CDRH: Case for Quality Program

The US FDA Center for Devices and Radiological Health (CDRH) Case for Quality program promotes a risk-based, product quality–focused, and patient-centric approach to computerized systems. This approach encourages critical thinking based on product and process knowledge and quality risk management over prescriptive documentation-driven approaches.