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FDA Observation on Validation of Computerized System

Updated: Dec 19, 2022


Failure to maintain a written record and appropriate validation data of computer or other automated processes used to perform calculations in connection with laboratory analysis [21 CFR 211.68(b)]. Refer to FDA 483, Observation 12. For example, the accuracy of calculations performed by the [(b)(4)] Spectrophotometer has not been verified.


This is a typical failing within the validation of standard laboratory instrumentation, the failure to provide documented evidence that the software performs within specification.

Industry should ensure the testing of critical calculation as part of Operational Qualification. they can leveraged the supplier testing documents in case supplier has already validated and tested the software functionalities.

Whenever possible the supplier, as the Subject Matter Experts (SME) should be employed to provide this documented evidence, either at the factory or during the on site qualification.

An alternative method of ensuring quality could include a Supplier Quality Audit, with verification over the suppliers design, source code review process and testing. While this does not provide direct testing it provides sufficient relative quality assurance that the laboratory instrument is fit for purpose.

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