Validation of Computerized Laboratory Instruments and Equipment

In modem practice, which is so heavily dependent on instrumentation controlled by computers, vahdation and change control of the computer equipment and software are essential for demonstrating that data are processed accurately and consistently. When reviewing data it should be possible to determine from the documentation which computer equipment and software were used to process the data and generate the final results. The computer and software should be vahdated prior to use and documentation of all vahdation tests conducted should 

An excellent overview of the problem, particularly as it affects bioanalytical data and information submitted to the US FDA, was published by the Society for Quality Assurance (SQA 2000). The relevant regulatory documents on electronic documents and signatures are found as Part 11 of the US Code of Federal Regulations (CFR21 2003) and an FDA Guidance document is available (FDA 2003a). (Note that the FDA interprets the word equipment to include hardware and software as well as instrumentation.) The review of qualification of anal54ical instrumentation (Bansal 2004) includes a section on software validation and the same phases (DQ, IQ, OQ and PQ, see Section 9.5.1a) apply. 

All regulatory agencies adopt what amounts to a life cycle approach to developmental and operational control of computerized equipment, with emphasis on documentation of software development and quahty management especially in GLP environments. The life cycle for analytical instruments from the user s perspective includes the purchasing phase (including system/vendor qualification), the IQ, OQ and PQ phases of AIQ (Section 9.5.1a), the maintenance phase and, fmaEy, the retirement phase, which probably occurs more frequently with respect to computers and software than the analytical instruments 

As emphasized previously (Bansal 2004), software for instrument control, data acquisition and processing is nowadays usually all loaded on a computer connected to the instrument. Thus the functions of both hardware and software in providing analytical data are inextricably intertwined and the DQ should be performed by the manufacturer, who should also validate this software and provide users with a summary of the validation. However, in the installation phase, qualification of the entire instrument and software system is more efficient and indeed meaningful than modular vahdation of the software and hardware separately. Thus, the user qualifies the instrument control, data acquisition and processing software by testing the instrument according to the AIQ process described in Section 9.5.1a. 

Many analytical laboratories also use a laboratory information management system (LIMS), an example of stand-alone software. Vahdation of such software is administered by the software developer but user-site testing is also an essential part of the software development and vahdation cycle. The FDA requirements for these systems are described in a guidance document (FDA 2002). 

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