FW: Document Control/Quality Management

["Dan Goldstein" <DGoldstein -at- riverainmedical -dot- com>]

> -----Original Message-----
> From: Barry Campbell
> Sent: Monday, November 20, 2006 7:11 AM
> To: Amanda
> Cc: TECHWR-L
> Subject: Re: Document Control/Quality Management
> 
> On 11/19/06, Amanda wrote:
> 
> > I was recently charged with the task of locating "something 
> > that will help us do this" - referring to software for the 
> > control of documents in an ISO/FDA/CE regulated 
> > environment...
> 
> ...Or, since you mention FDA regulations, you're almost certainly
> required to comply with 21 CFR Part 11, and probably others.  (Does
> your firm make medical devices?  See ISO 13485:2003...)...
> 

... and for medical devices, see also FDA's 21 CFR 800 series
(http://tinyurl.com/y7xcxk), especially 21 CFR 820.

Document control software for regulatory environments can cost many
thousands of dollars. Given your inexperience, vendors might try to sell
you more software capabilities than you need, as well as more of their
own consulting time than you need (that's where their big bucks come
from). If you spend a day with a neutral consultant, who can honestly
rate various software products against your true needs, it's probably
worth the investment. Look for a firm with former FDA personnel on their
staff.

-- Dan Goldstein

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