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We have had
a large number of queries regarding the use of the Design Qualification, and we
have been amazed at the number of these queries that try to justify not using a
DQ at all.
Qualification (DS) is executed as the final verification that the Design
Specification (DS) if followed, will deliver the requirements that the end
user has detailed in the User Requirement Specifications (URS), and that the
design is compliant with all applicable regulatory, company, health and safety
visualise the standard V validation chart where you descend the left leg of the
V with the URS – FS – DS – (bottom of V) and ascend the right leg of the V, with
IQ – OQ – PQ. Then your DQ fits in
at the bottom of the V.
build equipment it must be authored and executed prior to build authority being
given. With new build of
facilities, it is extremely important since its execution verifies that the
facility as proposed in the DS does what the end user wants, legally, safely and
the Shelf’ equipment or software, it must be used to verify that the proposed
purchase can fulfil all the end user requirements as detailed in the URS.
It cannot be
over-emphasizes just how important the DQ is. There are many horrendous blunders perpetuated by some really clever dedicated individuals, which would have been caught at DQ level, if there had been one.
Validation Risk Assessment (Issue10.) -- $125.00
This popular Validation Risk Assessment (VRA) has now been edited and enlarged to include Part 11 assessment tables for you to use in classifying which of your predicate records require to be stored in compliance with 21 Part 11, and which do not. It also includes an Excel spreadsheet to allow you to establish a permanent record of all such judgements, as is now mandated by the regulatory authorities.