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At last some common sense is prevailing, and Part 11 has been
tamed. No longer the infamous, “You
can only use a PC as a typewriter”, how much did that little lot cost the
industry? Now it is clear, if it is
data produced in accordance with a predicate rule, and you store it
electronically, then Part 11 applies.
In line with this we have just brought out the Compendium of Predicate
Rules. We have had endless
enquiries about the possibility of producing this document.
appears to be a growing interest in the link between the User Requirements
Specification (URS) and the Design Specification (DS).
Design Qualification is both an emerging
regulatory requirement and a tool for project success. If structured and executed properly, it
can help assure the design is robust and complete, giving the project team and
QA reviewers a high degree of confidence that every requirement has been
factored into the design. Finally,
DQ cannot be performed without first formally defining requirements. Meeting requirements is the ultimate
objective of the project; verifying requirements have been met is the role of
concise statement, neatly states the obvious, but take us away from the standard
definition of validation (which we all know refers to “documented evidence of
consistent performance”). Does this
indicate a change in approach by the regulators, taking the emphasis away from
the (documented consistent performance) style and realigning it to the
”satisfying defined requirements” style.
Subtle, yet during reviews and audits, I have come across literally
hundreds of IQ’s and OQ’s, with no reference to a URS, because the URS was
considered not to be required. If
this is a change in expectations from the regulators, then it is in line with
our own document structure. From
the very start we have always emphasised the importance of the URS to DS links,
and the verification of these links with the execution of the DQ. To ensure this traceability we produced
our now popular three level URS.
We have had
many enquiries about validation packages, so we have now put three, (IQ, OQ, PQ), five (VP, URS, IQ, OQ, PQ), and seven
URS,VRA, IQ, OQ, PQ) document
packages together, offering a discounted price for the documents bought as part
of a package.
in the industry, and as someone who spent 18 years in the aviation industry,
prior to the last 18 in the pharmaceutical and medical device industries,
I cannot understand where the complacency comes from. The quality standards at times, are
abysmal. The engineering standards
at times are just awful, and can some enlightened person tell me what a NO BLAME
CULTURE is. How can you have a
no-blame-culture in a regulated industry, especially while the industry
standards are so poor. The FDA is
constantly increasing the compliance pressure, with CAPA issues cited in up to
50% of 483 warning letters.
Recently high profile FDA citations to pharmaceutical, biotech and
medical device companies have run into hundreds of millions of dollars. This
does not include class action lawsuits brought by consumers, which are becoming
more commonplace in today’s litigious society, and yet complacency and
no-blame-cultures, rule. I wonder if
the company chairmen know. <br>