Topic: SQA org vs. QA org

Message

I used to work in the pharmaceutical sector for a couple of years and
we had one 'QA' department which was split for non-IT and IT work.
The
QA IT group was in effect more of a QC group maintaining Standard
Operating Procedures (SOPs) but also checking that all documents and
procedures for validating any software where according to the SOPs.
It
definetely wasn't Risk-based, it was a 'we test everything' approach as
the opinion was that the GLP guidelines asked for that. Obviously that
stifled development which is one of the reasons I left as we didn't
really get anywhere.
When we got a new piece of software it could
either be off the shelf or developed in-house. This would then be
tested following the SOPs by the IT department. The QA IT team would
then check thath the IT department followed all rules, created all
documents, signed off everything, etc.

Author	Message
Vivek98 Newbie Joined: 30Apr2007 Online Status: Offline Posts: 1	Topic: SQA org vs. QA org Posted: 30Apr2007 at 5:19am
	I used to work in the pharmaceutical sector for a couple of years and we had one 'QA' department which was split for non-IT and IT work. The QA IT group was in effect more of a QC group maintaining Standard Operating Procedures (SOPs) but also checking that all documents and procedures for validating any software where according to the SOPs. It definetely wasn't Risk-based, it was a 'we test everything' approach as the opinion was that the GLP guidelines asked for that. Obviously that stifled development which is one of the reasons I left as we didn't really get anywhere. When we got a new piece of software it could either be off the shelf or developed in-house. This would then be tested following the SOPs by the IT department. The QA IT team would then check thath the IT department followed all rules, created all documents, signed off everything, etc. Post Resume: Click here to Upload your Resume & Apply for Jobs

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