Biographical Information
Colin Jones is a highly experienced and respected expert consultant in computer system validation, compliance, and 21 CFR Part 11. He has worked in the field of computer systems validation and compliance for over 20 years. He is an acknowledged specialist in the areas of Quality Management Systems and auditing.
He was member of the editorial team and heavily involved in the development and update of ISPE’s GAMP5 Guide - A Risk-Based Approach to Compliant GxP Computerized Systems.
He was a major contributor to, and editor of, theGAMP® Special Interest Group Guide - Complying with 21 CFR Part 11, Electronic Records and Electronic Signatures.
He also played a lead role in the development of GAMP® guidance on supplier audits.
He has detailed and extensive experience of all aspects of computer systems validation and compliance, covering ERP, MRPII, Manufacturing Execution, Electronic Document Management, EBRS, process control and monitoring, environmental monitoring, manufacturing equipment, and clinical trials.
He has been a consultant to many major pharmaceutical and healthcare companies advising on compliance and validation of computer systems:
• Advising clients on Current Good Manufacturing Practice as applied to computer systems, and advising on preparation for FDA and MCA inspection
• Advising clients on GLP and GCP requirements for computer systems
• Advising clients on meeting the requirements of US 21 CFR Part 11
• Production of Standard Operating Procedures covering the validation life-cycle, system operation, maintenance and control, and software purchase and development
• Advising and developing plans for company, site, and department compliance with US and EU regulations
• Supplier audits, assessments, and management
• Site compliance audits
• Management of teams involved in prospective and retrospective validation activities
• Preparation of reports for presentation to senior management and regulatory authorities
• Production of Validation Plans for GxP critical systems
• Developing and implementing client Quality Management Systems
He is a Director of Conformity, who provide strategic computer systems compliance, validation, and 21 CFR Part 11 consultancy and services to the pharmaceutical industry. He is a qualified ISO 9001 and TickIT auditor.
Colin Jones
Director
Conformity Ltd
PO Box 7
LLANRWST
LL26 0ZF
UK
Tel: +44 (0) 1492 642622
Fax: +44 (0) 870 458 1672
colin jones@conform-it.com
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