Implementing a validated system is a process/journey and Momentum Systems can help you implement the system with our proven and systematic approach.
The deliverables of such a project shall include a Validation Plan, IQ/OQ/PQ, FRS and Designs etc.
The system also includes features such as Audit Logs and Electronic Signatures to comply with regulatory requirements (such as 21 CFR Part 11).
More details regarding Part 11 can be provided on request.