Anyone in the Pharmaceutical or other regulated industry have passed through the validation of a mayor SAP Upgrade?

May I know what do you mean by "validation" of SAP upgrade? I thought valiadtion is done by SAP and user acceptance by clients.

In the pharmaceutical industry we are required from goverment agencies (FDA in my case) to comply with certain regulations like the 21 CFR 211 "Good Manufacturing Practices (GMP)". One of these GMP is to validate processes, equipment, and systems that have impact to the pharmaceutical products.

Validation can be defined as "establishing documented evidence which provides a high degree of assurance, that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes".

Similarily, Computer System Validation can be defined as "establishing documented evidence which provides a high degree of assurance, that a computer system will consistently function in accordance with its predetermined specifications and quality attributes".

Suppliers offers "validation documentation packages", but frequently pharmaceutical companies understand that this documentation is not enough to cover all requirements from the FDA and follow our own protocols (IQ/OQ/PQ) alone or complemented with the suppliers validation package.

Once a computer system (i.e. SAP) is validated, a change control system must be implemented. Among other things, future changes (custom programmimng, service packs from the supplier, complete version upgrade) to the software must be validated before "go live" or the "validated status" of the computer system is lost.

That GMP's validation statement sounds to similar to that os ISO9000.

I expect any major software upgrade to be Qa/Qc by the programmer company. There is ISO9000 for software development process.

On the user' side, what I have done so far is to do user acceptance test for any changes made in the testing region before transporting to the production region (Go Live). There is a form to initiate the change process & a sign off form to accept the change made in the system. By doing this, I guess we maintain the validation of our system.

[QUOTE]Originally posted by Josh:
That GMP's validation statement sounds to similar to that os ISO9000. [QUOTE]

It is very similar, any pharmaceutical company complying with all GMP requirements could pass the ISO9000 certification.

I read one advert for a cmms biz consultant & one of the reqts is to do regression analysis & UAT. I haven't done the regression before.

Regression Analysis to validate, me neither. User Acceptance Testing, yes, and very, very detailed.