Validation documentation & pharma co's

[David Handy <davidh -at- automsoft -dot- com>]

Has anyone written validation documentation e.g. for software applications
installed in pharmaceutical plants? Can they share any of the pros and cons
of doing so? 

I documenting plant data mgmt software, and I'll probably have to write some
documents that validate the operational behavior of the software for the
purposes of compliance with FDA regulations, specifically 21 CFR Pt 11. 

I don't expect any cheat sheets on this task, I hasten to add. I'm
interested in general observations on issues such as: 

* how long a project took; 
* whether it was doable in-house; 
* whether or not specific training was required; 
* whether internal quality systems or ISO certification 
   overlap with the project; 
* whether document security was an issue, 
   and if so, did an e-signature solution like Acrobat 5 fit the bill. 

Or any other observations anyone might have. 

For this relief much thanks,
DH
davidh -at- automsoft -dot- com

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