Mr. Chris Clark

Chris Clark, Director, TenTenTen Consulting Limited, providing advice and direct support to overcome the business and regulatory challenges to patient safety, product quality and data integrity, encountered when implementing and operating computerized systems within the pharmaceutical and life sciences industries. He has 40 years+ experience of Quality Control / Quality Assurance within the pharmaceutical and other regulated life sciences industries covering non-sterile / sterile manufacturing, clinical and computerized systems. He is an experienced leader of teams responsible for ensuring compliance to international GxP’s. Chris has specialized experience in ensuring compliance of a wide range of computerized systems (Laboratory systems, MRP systems, Documentation Management systems, Clinical systems) and has assisted an IT service provider to develop a quality management system to support IT Service Management (ITIL®). He has a proven track record of IT Vendor and services audits. Chris is a contributor of ISPE’s GAMP® 5 Guide A Risk-Based Approach to Compliant GxP Computerized System Second Edition and is the current Chair of the GAMP® Editorial Board and a member of the GAMP® Global Steering Committee.