I am a functional consultant who is currently a member of the OQ testing team of my client. I am new to this forum (and to the field of validation per se). I have 2 questions
If there are 10 tests to be done for the function/module “material management” as per the test protocol and if the test protocol has not said specifically that beyond those 10 tests no other test should be done, then is it permitted to do some new tests or repeat a test with new data set ? It is not required to document those new tests or repeat tests, but they only need to be executed simply to see whether some undocumented URS can be met with.
Is it permitted for a tester in module “material management” to execute a test for the module “production” if the “material management tester” is capable of executing that test with the same level of accuracy as the "production tester " ?
First, keep in mind that the objective of validation is to ensure the equipment performs to your specifications AND needs. If there’s a chance that additional testing will reveal a potential flaw, why wouldn’t you do it? Protocols are (at best) a snapshot of what is considered sufficient and reasonable. We often budget in “exploratory” or “ad hoc” testing just to provide some freedom for evaluation beyond that which is documented (protocols). These results may or may not go into the validation report (often they do).
Second, you mention “undocumented URS.” Depending on the severity, that could be quite an issue. I realize you can’t document everything so maybe you’re talking just about some general assumptions. Again, if the tester believes there’s a potential flaw that could be revealed through such testing, it should be encouraged.
As far as who performs testing goes, there is no prescribed individual or function that must execute the protocols. If the individual is qualified and unbiased, I don’t see a reason why they couldn’t perform the test. In fact, when you get someone outside the normal function to perform testing, you eliminate assumptions which sometimes reveals surprising results.
You can make an addendum to the main protocol before executing new test & reports can be summarized together with main report only.
Note that from cGMP perspective all the test / events performed intended / un-intended need to be recorded.
One who is qualified & trained on the subject matter can perform the qualification. Qualified & Trained means…subject expertization well documented trainings.
Thank you for the reply. My 2nd question was adequately answered, regarding the first one i have some further qureies. To start with, you are absolutely correct in assuming that by "undocumented URS" i mean some general assumptions made while preparing the URS.
My queries are
We often budget in “exploratory” or “ad hoc” testing just to provide some freedom for evaluation beyond that which is documented (protocols).
Where is the scope to mention that in black and white, can it be mentioned as part of the protocol that for example, in addition to the 10 tests further tests may be performed ?
These results may or may not go into the validation report (often they do).
On what basis should we decide whether they should go or shouldn’t ?