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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.


Now there 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 qualification.

A very 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 (VMP, VMP<computer>),
URS,VRA, IQ, OQ, PQ) document packages together, offering a discounted price for the documents bought as part of a package.


Complacency abounds 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>