Facility Monitoring Systems Validation: A Practical Approach 6

Tests to check that colors and font sizes on a system are correct can be performed, but they add little to building assurance.
The final part of testing is Performance Qualification (PQ). Normally PQ tests are designed to ensure that the machine operates at the correct rates with the users’ product. With facility monitoring systems, however, this does not apply and in many cases PQ is not performed. With sites where manual methods were previously used to monitor the facility (with portable particle counters, for example, and other instruments), a comparison of the portable particle counters and the FMS particle counters is performed. This can quite often cause test failures due to differences between particle counter optics, electronics, and testing methods. When this happens, I recommend that the manufactures of the particle counters be contacted for guidance.
Other documents should also be generated for a full validation. The main one is a Project Completion Report (PCR) or Validation Review Report (VRR). A summary of the validation of the project, the VRR should list all the documents that have been generated along with the outcome of the tests and should include a clear statement of the system’s suitability for use.
Supplier audits are also common for user to perform. These should be conducted prior to order placement to ensure the supplier has good quality systems and is capable of supplying the required system.

21 CFR, Part 11 Regulation
21 CFR, Part 11 regulation by the FDA relates to electronic signatures and electronic records. Most facility monitoring software systems do not use electronic signatures to approve batch release information. But all facility monitoring software systems hold electronic data, so the regulation applies. In general, facility monitoring systems are closed systems, with access to the system and system data restricted by a control method. In this case, although providing electronic signatures is not applicable, Subpart B, Paragraph 11.10 is applicable.

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