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Validation Initiation.
Validation starts at the VMP stage and flows through a series of documents that define the scope and tasks required to successfully qualify the equipment.
The VMP will dictate the actions that all persons involved in validation projects must comply with. The individual equipment VP’s will define the scope of the validation actions along with detailing individual responsibilities for completing the qualification process, successfully.

Document Sequence.
VP - URS - DQ - VRA - IQ - OQ - P1Q - P2Q.

The first document (VMP) is not mandated, but is always asked for in regulatory reviews. (URS - DQ - VRA) are mandated and self explanatory. (IQ - OQ - P1Q - P2Q) Installation Qualification - Operational Qualification – Performance Qualification - Process Qualification. Regulators are expert at memorising dates, with this document cascade, dates are extremely important. Do the dates of all the signatures on a document precede the date on the next document in the sequence? Are all the instrument calibrations dated, prior to a document execution date?

Document Content.
There is some flexibility about the content of these documents. Do you wait for power on to do IQ, perhaps - perhaps not? It can be argued that when power is on you are operating the equipment. This is where the VP becomes a vital document. Senior persons with a good understanding of the overall project, decide the content and scope of each of these documents, obviously within cGMP constraints. They can derive a unique sequence of validation tasks for a number of reasons (to reduce repetitive testing – to ease access problems and on), providing that their reasoning is documented in the VP and fully justified, it is normally acceptable with the regulators. The VP is then used by the writers as the official mandate for protocol content.

What Is Validation.
We all have heard the diatribe about documented evidence etc. Now validation is being referred to as;

Verification that the Users Requirements have been fully satisfied.
By implication, no URS renders an item impossible to validate. So none of these documents can stand on their own.

Finally in response to requests for demonstration documents we have included (ONLY in this letter) a half price Installation Qualification, to allow people to sample the document. This offer is not available from our website, only from this letter. The offer will lapse in 7 days.

Alex Kennedy
Principle Engineer