For laboratory computerized systems our procedures and practices are
informed primarily by the “GAMP Good Practice Guide: Validation of
Laboratory Computerized Systems”, however I have a particular
question concerning systems we purchase for which we have no methods
developed. Our proposal is that after we have assessed, selected,
and purchased a new laboratory instrument (typically falling
somewhere in categories D-G per the GAMP guide for purposes of my
question), we will do the following:
(1) Tag it “not in service” per procedures
(2) Approve and perform vendor protocols to test basic instrument
(3) Have QC explore the instrument functionality, learn the system,
develop a method, and perform method validation.
(4) Submit to FDA for approval to use new method.
(5) Permission to use new method granted.
(6) Open a change control to initiate a validation project (DQ, IQ,
OQ, and PQ) of the instrument for the method developed.
(7) QA will remove “not in service” tag once change is approved to
implement per change control and system will be released for GMP use
My question is it necessary in terms of data integrity/security to
conduct/repeat method validation after DQ,IQ, and OQ, such that it is
part of or constitutes the PQ and then submit it to the agency? Or
is acceptable to submit it to the agency with the vendor protocols
alone supporting legitimacy of the instrument being sufficient, prior
to embarking on validation of the system for its intended use?