Validation is an integral part of the computer system life cycle, from the planning stage to the stage of retirement. This is clearly stated in Annex 11 of the European GMP and the FDA’s 21 CFR Part 11.
Based on our experience in the Life Sciences industry, we understand that the validation of READY! is a fundamental requirement for our clients.
READY! is fit for the purpose from a regulatory and business perspective, including operational benefits.
The Nanokinetik Quality Management System (QMS) is based on our extensive industry experience and up-to-date with the latest regulatory developments and industry trends.
We have successfully passed all audits performed by our clients.
GAMP5 methodology followed:
Stage 1: Planning and Specification
Stage 2: Installation on the test and production environments