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valentine.gumyvalentine.gumy 

Validation of protocol/scipt

Dear all,

I'm currently looking for some information about how to validate a protocol created in Pipeline Pilot? The idea is to be able to use this protocol in a GMP environment.

Do you have any suggestions? Process?

Thank you in advance for your answers

Kind regards
 

Valentine

dana.honeycutt1dana.honeycutt1
On the Administration portal, see the Validation Rules page under Setup. This allows you to specify validation rules for all protocols and optionally to require protocols to pass validation before they can be saved or exported. The rule checking is done by a protocol which by default is Protocols/Utilities/Validation/Protocol Validation Rules (Default), but you can override this by providing your own validation protocol. (The default set of rules checks for non-empty password parameters, valid file paths, valid protocol links, etc.)

In the Pipeline Pilot client, you can select "Validate Protocol' from the Tools menu to validate the currently open protocol. This allows users to see if there are any issues with their protocols before they attempt to save them.
Matthew BrownMatthew Brown
If I understand your post, you are looking to validate a Pipeline Pilot Protocol for 21 CFR Part 11 / Annex 11 compliance; is that correct? If so, then I don’t think the internal Pipeline Pilot “Validation Rules” are what you are looking for. As I understand it, “Validation Rules” are for ensuring the protocols meet certain criteria established by the administrators; Part 11 compliance is about testing and documenting that a computer system works as intended as part of a GxP process (think patient safety).

We have also considered the feasibility of validating a Pipeline Pilot Protocol, but never actually done it. The problem is the level of effort required to ensure high confidence in the results. Because Pipeline Pilot is a platform (as opposed to an application), it needs to be tested like a custom coded application, with code review, regression testing, limit testing, etc. Also, change management is difficult since it is relatively easy to update protocols. That means you will need good SOPs and training in place to ensure that your production protocols don’t get modified without extensive testing and approvals.

That said, if you can evaluate, document, and effectively mitigate risks, it may be possible.