From: Motise, Paul J.
Sent: Wednesday, December 04, 2002 9:37 AM
To: Butler, Jennie C
Subject: FW: Requested comments on Docket number 00D-1539, Maintenance

Jennie,

Would you kindly post the attached to Docket 00D-1539?  Thanks much.

Paul

-----Original Message-----
From: Bistervels, J.J.E. (Jean-jacques) [mailto:jean-jacques.bistervels@organon.com] 
Sent: Friday, November 29, 2002 10:47 AM
To: 'pmotise@ora.fda.gov'
Cc: Janssen, P.G.M.J. (Paul); Damm, J.B.L. (Jan); Canninga, G. (Gerben); Bolier, A.P. (Ton); Vervoort, P.E.M. (Piet); Aelst, S.F. van (Sjoerd); Lathouwers, G.P. (Guido)
Subject: Requested comments on Docket number 00D-1539, Maintenance


Dear Sir,

Enclosed with this e-mail you will find the comments from the 21 CFR Part 11 Compliance Platform from NV Organon on the Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures, Maintenance of Electronic Records. 

Due to the short period until the closing date for sending comments on the mentioned document, I send you our comments via e-mail. I hope this is not a problem and that our comments can contribute to the development of the final Guidance.

Organon will also officially deliver the document at the address which is indicated on the Draft Guidance.

In case you require any elaboration on our comments, please do not hesitate to contact us.

Sincerely yours,
On behalf of NV Organon



J.E. Bistervels MSc. RE
Quality Assurance Officer ICT
Quality Systems Department
N.V. Organon Oss, The Netherlands 
Phone: +31 412 665025

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