Landing Page one
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.
The Design 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 requirements.
If you 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.
With new 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 securely.
With ‘Off 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.