Q&A from a recent one of my VMP (Validation Master Plan[ing]) Webinars

Ques:  Using vendor developed/administered tests as part of a company's qualification for vendor-supplied production / test equipment.

Many times vendor templates are not meeting internal documentation requirements. For example all tests are not signed/checked individually; one signed at the end of page or document.

How to handle this when vendor documentation is not fulfilling internal requirements?

Ans:  As mentioned, you would have to "fill in the blanks" with supplemental verifications/testing, so the vendor's documentation and the additional verifications complete your company's SOP requirements for the validation.

 

Ques:  Risk based validation.

Is validation really risk based if it is based just on URS requirements. A Validation is checking just URS requirements and maybe some internal documents. Should there be a formal risk assessment on which validation is based?

 

Ans:  Risk, i.e., patient safety (ISO 14971, ICH Q9)-based Risk Management Reports/Files addressing the subject being validated, are used to direct the test cases focus, depth, size, sampling, design, et al - not just the URS.  The higher the risk based on the Risk Management File / ISO 14971:2019, the more detail, et al, included in the V&V Report's test cases as per an example test case in the webinar (the test case introduction / narrative ties that test case to specific references / line items on a Risk File document, e.g., FMECA) to define the patient risk associated with that test case.     

 

Ques:  Documentation practices.

Test should be signed individually and at right time (in real time).

In some cases multiple tests are on same page and only one signature at the end of the page. Is this really fulfilling the requirement of right time?

 

Ans:  It depends.  FDA's Guidance Document on Data Integrity on test data does not agree with different test's data being combined under one signature  (in my opinion).  However, if one signature is used  to certify the accuracy of the report, with supporting information and signatures for the individual reports readily available elsewhere, that may be allowable, depending...  And would have to be clearly stated how it can be viewed as allowable in an SOP which is then followed!

 

Ques:  Document templates. During the webinar  specific example test templates weren’t available. Are they now?

 

Ans:  No,  That would be a specific consulting project. Complete validation templates are very specialized / unique and I don't supply them in an "all-purpose" webinar.  I do develop them as part of a dedicated consulting project.  However, the basic /generic format / outline was provided a couple of times on the slides, as well as an example of an IQ check list, an OQ test case and a PQ multiple sample (n=10, n=30 ...) test case, which all also can vary.  A list of product tests / verifications was also included in the slides:

E.g., Basic Test Report Format:

• Control Number, Title
• Scope, Purpose
• Pre-Approval
• Test description, lay-out, drawings / pix...
• Pre-determined test acceptance criteria
• Test materials (P/N, Lot No., description, Qty...)
• Test equipment (asset no., S/N, Model, Description...)
• DQ, IQ, OQ, PQs -list or test cases
• Software 10 elements (see Blog, elsewhere) if applicable, Pt 11 (OQ), Cybersecurity (OQ, if applicable
• Results:  Filled-in test cases. data sheets
• Conclusions:  Compare test case results to pre-determined acceptance criteria
• Appendix:  Training Record copies, calibration ccs,  red-lined SOPs, etc.

-- jel@jelincoln.com