In a world where some of us are trying to encourage a common sense
approach to validation- and believing that the FDA supports such
thinking- why would the FDA issue a Warning Letter yesterday
containing this little gem?
"2. Failure to assure that when computers or automated data
processing systems are used as part of the production or quality
system the manufacturer shall validate computer software for its
intended use according to an established protocol, as required by 21
CFR 820.70(i). For example, electronic records are used, but there
was no software validation. No procedures are established to
validate for its intended purpose the Microsoft Word or Microsoft
Excel software used in creating and maintaining nonconformance
records, product return records, internal audit corrective action
records, or preventive action records.
We have reviewed your response and have concluded that it is
inadequate because off-the-shelf software must be validated for its
intended purpose. You have stated that a review will be conducted of
the existing forms and an implementation of a new record control
system to meet FDA requirements will be pursued. A new system may
not be necessary; however, no procedures have been submitted for
review and no timetable for corrective action and response was
Now- maybe it is just poorly worded. Maybe the device manufacturer
had lots of complex macros that had not been validated. Maybe they
had not recorded the installation details for these apps…
but, anyone could be forgiven for thinking that the FDA want
legions of consultants sitting about at every company (i.e. multiple
repetitions of testing) verifying that B1+B2=B3, that Word is able
to print accurately and other redundant nonsense.
Word and Excel are probably the most tested software applications in
history. If the cliche “risk-based validation” means anything- it
has to mean that we accept these platform applications as being of
negligible risk in 99.9% of situations.
Perhaps the agency meant something more subtle than I am
interpreting, but if so- they missed a golden opportunity to either
be explicit or to say nothing.
Money diverted towards such non-productive activity, is money
diverted away from addressing real concerns. Such statements from
the FDA encourage cynicism that this validation stuff IS a waste of
time. Does the agency management not realize the extent to which
Warning Letters are examined to predict future enforcement behavior?
Are they deliberately trying to undo 4 years of effort to try to
encourage risk-averse companies/individuals to embrace pragmatism?