GoogleIt Mail IT Print IT PermaLinkFDA Fails On Record Retention
03:54:11 PM
Written By : Richard SchwartzCategory : Industry News And Comment
Location : Nashua, NH

There's a bit of a controversy brewing about political interference in drug approvals at the FDA. I'm not going to go into that, but I do think it's worth commenting on one aspect of what's being reported. Most people in our business have probably heard about 21 CFR Part 11, which is the set of regulations established to cover electronic records retention and electronic signature for documentation of processes that are subject to regulation by the Food and Drug Administration. Long before anyone had heard about Sarbanes-Oxley or most of the other regulatory compliance buzzwords that we hear about these days, CFR Part 11 compliance was a big deal for a lot of companies, and a significant proportion of FDA-regulated firms have turned to Lotus Notes and Domino for solutions. It therefore struck me as odd that the FDA would have lost their own Commissioner's emails!

From an article a couple of days ago in the New York Times:

The letter noted that Congressional investigators had been unable to uncover the role in the Plan B decision played by the former agency commissioner, Dr. Mark B. McClellan, because agency officials told investigators that all of his e-mail messages and written correspondence on the subject had been deleted or thrown out.

Quite unbelievable, if true. I wonder what the FDA uses for email? I wonder what they use for archiving and backup?

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Comments :v

1. Joerg Michael11/17/2005 05:23:36 PM

Well, looks like it's not Domino manning the gates - but wait, what's with that "MSEXCH:" stuff in the last line?

Your message

Sent: Thu, 17 Nov 2005 17:16:33 -0500

did not reach the following recipient(s):

MICKEY.MOUSE@FDA.GOV on Thu, 17 Nov 2005 17:16:38 -0500
The recipient name is not recognized
The MTS-ID of the original message is: c=us;a=
MSEXCH:IMS:FDA:FDAresource:FDARESS14 0 (000C05A6) Unknown Recipient

2. Richard Schwartz11/17/2005 06:14:50 PM

LOL! Good one! If it means what I think it means, then I guess I can understand how they lost the email

3. Joerg11/17/2005 07:08:03 PM

Yeah, they have to delete all their stored mail when the database hits its limit. Which, I understand, happens fairly frequently with that Notes database killer.

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