Problems of validation of computerised instruments for accredited chemical laboratories |
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Authors: | Z Dobkowski |
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Institution: | (1) Industrial Chemistry Research Institute (ICRI) Rydygiera 8, PL-01-793 Warsaw, Poland Tel.: +48-22-633-82-98; Fax: +48-22-633-82-95; e-mail: zbigdo@aquila.ichp.waw.pl, PL |
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Abstract: | Some problems of validation of computerised instruments are reviewed briefly, taking essential standards and guides into
account. The significant role of certified standard reference materials is underlined. An attitude of suppliers towards the
validation of instruments is presented, and producers' responsibilities and obligations are discussed. The "black-box" concept
is recommended as a preliminary step for the validation of computerised instruments. Two examples for gel permeation chromatography
are given that illustrate a bad manufacturer's practice (BMP) and good manufacturer's practice (GMP). In the case of BMP,
a need is expressed for a guide and for regulations that should be implemented into the quality assurance system. It has been
proposed that the EURACHEM/VAM draft of guidance for qualification/validation of instruments should be amended by incorporating
the "black-box" approach as a preliminary procedure for validation of computerised instruments, a retrospective validation
procedure if the need for current validation was not foreseen or not specified, and a procedure (or selection rules) for qualification
of the supplier. Moreover, the mechanisms of inspection to control the observance of the standardised rules and commonly recognised
recommendations should also be considered by international quality organisations.
Received: 19 November 1996 · Accepted: 20 March 1997 |
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Keywords: | Validation of computerised instruments Black-box concept for validation |
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