Part11 Computer Validation Services
Achieving and maintaining compliance with applicable GxP regulations such as FDA 21 CFR Part 11, GAMP5 and fitness for intended use by:
• the adoption of principles, approaches and life cycle activities within the framework of validation plans and reports
• The application of appropriate operational controls throughout the life of the system
We will produce a report and present our findings back to you. The next step is your decision. You may be able to justify the decision not to validate. The report will clearly outline what aspects of the system need computer systems validation or if a procedure would suffice. If may not need to be validated at all. If so, the decisions are justified and documented.
If validation of the computer systems is necessary, a phase 2 is executed. We can do computer system validation for you or direct your software validation engineers as to what needs to be done. We can supply you with the templates you need. Read More...
Contact us for further information on what we can do for your organisation.
Phone: +353 (0)21 240 6250