I work for a company that has developed a system that electronically captures and stores clinical study trial data. We use Starteam as our document manager (source code, documentation, etc). Since we are involved in the storage of this study information we subject to FDA audits so we need to validate Starteam. To say the information from the FDA regarding 'off the shelf' software validation is on the light side would be a gross understatement. Does anyone have any experience or input regarding the testing of document managers/project data repositories? I'm fairly new to SQA; and I'm really not to sure where to begin. Any input would be appreciated.
The FDA is Federal Drug Agency.
Probably start taking a look at some of these terms,
Change Control Document,
Computer Software validation,
It has everything do about 21CFR part11.Dig deep into google dungeons.I am sure you will be richily rewarded.
Where to start - I am in and have been in SQA in an FDA environment since 1997. There are many places to look.
Documentum is used by many such companies - a search on that tool would help.
Many of the Rational products are used by FDA regulated companies. They would be an excellent source.
The CMM at SEI deals with the concept of COTS software and also with regulated environments.
I am not aware of part 11 dealing directly with all COTS unless the software is the only source of information. Many places use paper and a database for tracking. Part 11 only hits in a major way if everything is being tracked electronically. Many systems already have a fair amount of the Part 11 requirements built into them.
Part 11 just was just recently altered by the FDA. They pulled the reg and replaced it with something milder pending further work on their part.
I would be glad to dialogue directly with you if that would help.