Have you qualified the software for your analytical instruments?

Before you can start validating a method for analytical testing on your instrument, you first must make sure that the instrument you are using is suitable for its intended use.  To do that you must perform a qualification of your instrument (USP General Chapter <1058> Analytical Instrument Qualification).  If you have an instrument that also has a computerized component, you must also qualify software for the computer component. (21 CFR 211.68(b))

A company recently received the following observation:

….. Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

Specifically, your data acquisition software and workstations, including the systems used for your chromatography instruments, have not been suitably qualified to ensure that the data generated for release and stability sample testing of drug products, including … and …, are reviewed, complete, and attributable. For example:

Your firm uses stand-alone workstations connected to analytical instrumentation, including your ICP-MS instrument, which uses partially or non-validated data acquisition and processing software where audit trails are not enabled. According to procedure SOP…, “Analytical Method Performance”, these instruments follow your film’s “two-man- rule … to fulfill the requirement for not having an electronic audit trail” and requires the second analyst to “witness a print-out of the file names and dates created as soon as practical after they are created”. However, your Associate Manager stated that the two- man-rule is used for review of the …, and … information prior to data acquisition. The two-man-rule is not used for raw data review of post-acquisition activities including the processing of the raw data or any potentially unreported data, to ensure all the data generated for a particular project is complete. In addition, laboratory personnel do not have unique usernames and passwords to the stand-alone workstations to ensure that all data generated within the software is attributable.

For more information on implementing controls for electronic systems, refer to the FDA Guidance Document, Guidance for Industry: Part 11, Electronic Records; Electronic Signatures – Scope and Application August 2003.

To view more observations pertaining to software qualification, refer to the following GMP Trends® Issues: 1114, 1095, 1061, and 1044. 

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