Computer System Validation Expert ( 21 CFR 11.10(a) and Annex 11)

I am an Expert in Regulatory Compliance Solutions and a well-rounded professional with solid experience in the life sciences industry regulatory audits such as 21 CFR Part 11, Part 211 and Part 820.

I am dedicated to helping companies address the requirements in 21 CFR Part 11 Electronic Records and Electronic Signatures and Annex 11, Computerized Systems. I view validation as an opportunity for a business to add value to their computer systems.

If you are implementing new systems or trying to bring older systems into compliance, i can validate all of your software, databases, spreadsheets, and computer systems, and develop the appropriate documentation for all phases of the software life cycle. I have written (and executed) commercially available validation packages. I can provide any level of service required, from executing test scripts generated from your existing specifications to writing the entire validation package. I can follow your existing validation procedures or provide your company with validation standards. My validation methodology ensures validation deliverables that exceed your highest standards, focus resources towards the most critical system functions, and complete the validation projects in less time (and money).