Signature Policies and regulated environments (including validation)

Technical Questions and Answers
1

Dear Senaite Community,
is it possible in Senaite to have 1 author, 1 verifier and 1 release signature? This is a requirement in GMP regulated Labs.
Does someone have experience with LIMS in GMP regulated Labs (or propably GLP as well)?

Thanks,
Andreas

2

Hi Andreas,

do you mean 1 author, 1 verifier and 1 release signature in the final results report (aka. “Werkszeugnis” based on DIN EN 10204)? If so, then this would be possible with senaite.impress (https://github.com/senaite/senaite.impress), but with some customizations regarding the release process and probably versioning of some test-plans/profiles to get this “author” signature in place.

Not sure if this answers your question, maybe you can provide more details.

Thanks and best regards
Ramon

3

Well, thanks for your input.
Definitely, the impress Plugin would be nice AS it would allow creating custom reports (CoA templates).
Our workflow would be like this:

  • sample (drug product) comes in
  • reference standard comes in
  • distinct analysis are made (ph, Osmolality, Water Content, Assay (HPLC))
  • I get back the results from all instruments / methods
  • for each of those, i need the performing analyst written somewhere
  • a second analyst will verify the results of each assay (Signaturen by password entry)
  • a head of quality control will review all results of that drug product and release the results (Signaturen by password Entry)
  • for each results I need to be able to show who signed for what part in the End
  • then, make a CoA oft all results for one drug product
  • the CoA is released by head of QC
  • at that point the CoA Kay be sent to the customer
    I think Senaite would be up to the task. Just wondering how to get the Signaturen right.
4

Hi,

for each results I need to be able to show who signed for what part in the End

All this information is logged by senaite in every single analysis service:

  • Analysts submit results.
  • Verifiers verify those results. (In your case you need 2 verifications, it’s configurable)
  • Managers publish the CoA

On demand the full audit trail is viewable.
If you don’t need to show this bunch of logs on the CoA it will be easy.

Stefan

1 Like
5

Ok, thanks grulisco, this sounds really good!
Another point very relevant for me is the validation of the LIMS:

  • is there any kind of validation been done of Senaite LIMS? For example acc. 21 CFR Part 11 “Electronic Records and Electronic Signatures” or acc. EU GMP Guide Annex 11 and Annex 15?
    • I mean: Tests, that all functions work as expected, by design
  • is there any guidance as how to validate if Senaite has been isntalled properly and is functioning as designed (after isntallation and according previous validation)
    • I mean: what tests to perform, to show that it was installed properly

Thanks guys for your support!

Andreas

6

I don’t think that senaite is validated by third parties.
We plan to test and validate senaite ourselves.

Here’s an example of the analysis log:

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Stefan

7

The log looks OK.

Do you habe a plan in validation already?
Is there any guidance specific to Senaite Validation?

Thanks,
Andreas

8

Hi Andreas,

as our lab is not regulated but accredited by german DAkkS we have to follow this guide:
https://www.dakks.de/content/leitfaden-zum-einsatz-von-computersystemen-akkreditierten-laboratorien

We plan to test, introduce senaite LIMS while auditing it by those guidelines. (…and keep records about this process)
If some topics will not be sufficient in technical sense we have to complement our processes with organisational measures.

Stefan

9

See also 21 CFR Part 11 Compliance GAP Analysis