Computer System Validation in pharma

General discussion of Mantis.

Moderators: Developer, Contributor

Post Reply
Matteo.Z
Posts: 2
Joined: 28 Jul 2021, 02:19

Computer System Validation in pharma

Post by Matteo.Z »

Hello everyone,
I wonder whether anyone has already had the experience of trying to perform the Computer System Validation in pharmaceutical GMP environment of MantisBT.
Being an excellent tracker, I think it could be easily used to manage Change Controls, Deviations, OOS, OOT, etc.
Opinions? Please share your experience!
rabbit
Posts: 6
Joined: 12 Jun 2021, 06:32

Re: Computer System Validation in pharma

Post by rabbit »

Hi Matteo.
I'm currently working in the medical device industry, so we do have similar topics.

Yes, mantis is working great as deviation tracking from audits, internal deviation reports, or changes etc.
Most important thing is to configure it correctly, e.g. renaming many fields, remove unnecessary fields (e.g. software version etc), define the projects properly, creating custom fields, renaming/recreate permission levels etc.
Once you've done that, it's just great.

We currently use it as CRM-Tool as well (ok, I would say that's off label use, however, with a bit of imagination it works well too. At least my marketing manager is excited!).

A very quick trick:
Just rename "Clone"-Button to "CAPA-Button" and set the standard relationship to "child of" and your ready to go with CAPAs of deviations, OOS, OOTs ...
Matteo.Z
Posts: 2
Joined: 28 Jul 2021, 02:19

Re: Computer System Validation in pharma

Post by Matteo.Z »

Thank you rabbit! I really appreciate your feedback.
We have already done some fine tuning and personalization on fields.
The most difficult part is still to convince old-style IT and upper management.
Post Reply