Facility Monitoring Systems Validation: A Practical Approach 5

The supplier’s module tests and SQ tests can be quite informal. By this I mean that the tests don’t have to be proscriptive. This allows the engineers to really test the system without spending an excessive amount of time generating test documents. The purpose of the test, however, must be clear and there must be documented evidence that the test has been conducted. During IQ/OQ/PQ, the tests must be very proscriptive to enable the user to perform the tests. The test evidence should be more than just a mark in a check box: physical evidence of the test (printouts, screenshots, photos, etc.) should be supplied. It is primarily this test evidence that will be presented to an MCA or FDA inspector to show that the function performed as required. Suppliers are all responsible for ensuring that they provide the user with sufficient documented evidence to pass an inspection.
Tests within Installation Qualification (IQ) may vary. IQ tests should verify that all the items listed in the functional specification have been delivered and that they are of the correct type. The FS may have stated that a differential pressure transducer 0-100 Pa is to be used with 1% accuracy. Has it?

The IQ test should check and verify that:

• All hardware installed on site is as stated—or better.
• All support systems are in place (user manuals, technical manuals, system diagrams, etc.).
• All instruments have been calibrated and the calibration is still valid.
• All software system discs (CDs) are available and have been properly filed.
• A “footprint” (system files, dates and sizes) of the software has been taken at this point.

A system must be able to be re-validated at a later date. IQ tests to ensure that all inputs/outputs of a data collection unit are operational and that must be conducted to ensure that all switches, lights, transducers, and such are functional. These tests can be regarded as operational tests; some companies include such tests in the Operational Qualification (OQ) test document. Once it has been documented that the system has been supplied as detailed within the FS, OQ can begin. The purpose of OQ is to verify that the system functions (operates) as stated within the FS. There must be a test to show that each of the items listed within the FS have been tested, but the tests should go further than this, especially with FMSs—or for that matter, with any other data collection system. There must be clear tests that show data is being collected correctly and that manipulations are being correctly applied, and that data is being stored correctly and can be retrieved correctly.