Has anyone tried to validate PBI in a GMP environment?

[Jim_]

Hi All,

I work in Bio-Pharma and some of the data that we would like to process through PBI would be used for GMP decision making.  Has anyone validated an installation/report in this environment?

Thanks!!!

Jim

[Greg_Deckler]

Good Manufacturing Process? Green Mountain Power? 

[Jim_]

Good Manufacturing Process-Of course if you can't connect GMP and Bio-Pharma, the answer tomy question is likely no 😉

[Greg_Deckler]

OK, my understanding of GMP in that context kind of entails these high-level sorts of things:

• Manufacturing facilities must maintain a clean and hygienic manufacturing area.
• Controlled environmental conditions in order to prevent cross contamination of food or drug product from adulterants that may render the product unsafe for human consumption.
• Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
• Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that affect the quality of the drug are validated as necessary.
• Instructions and procedures are written in clear and unambiguous language (good documentation practices).
• Operators are trained to carry out and document procedures.
• Cross contamination with unlabelled major allergens is prevented.
• Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the food or drug was as expected. Deviations are investigated and documented.
• Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
• The distribution of the food or drugs minimizes any risk to their quality.
• A system is available for recalling any batch from sale or supply.
• Complaints about marketed products are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective products and to prevent recurrence.

So, are you worried about cross-contamination of food that Power BI might cause? I can't understand exactly what your're going for here.

[Jim_]

No offense intended, but if you do not understand what it means for something to be validated in a GMP environment this is probably just not the thread for you to comment on.

[Simi02]

Hi @Jim_ not sure if you got any response on this?
Would be great if you could share how you managed the validatate Bi , did you end up validating the tool?
I would think that its a out of the box widely used in market tool , so wouldnt require extensive validation.
Would just need to document the configuration and management of the tool and have a procedure in place to create,review,test  and publish Reports .

Regards

[Anonymous]

Hi all,

I know this is an old thread, but I am currently doing this and so I thought I could add some value.

We have created a distinction between the centrally managed Power BI service (e.g. Admin Portal settings, Licensing, Monitoring/Governance, etc) and the individual GxP report owners.  We've put the right documentation (validation plan, risk assesssments etc) and controls in for the Power BI service (E.g. full documentation and approval of admin setting changes) and we've written clear guidance for report owners on what they must do.  The quality team then have to support the indvidual report owners on their validation work.

For report owners, we've included responsibilities such as:

- GxP reports must use a deployment pipeline (with appropriate management of the Production workspace to ensure only approved content ends up there).

- A code review is performed in the Dev workspace and documented

- A business testing phase happens in the Test workspace and is documented

Hopefully this helps to illustrate an approach which might help others.

[Anonymous]

I have a question for the author. I also work in GMP and am considering validating a Power BI report. Did you follow through and validate your Power Bi report?

Thank you.

zach