21 CFR PART 11 - FDA.COMs Community Forums

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Post: 21 CFR PART 11

PaulS
Member
Posts: 177

Registered on 01-24-06

08-06-08 11:24 AM - Post#4875
In response to sdnare

Dear Sdnare
Just to clarify..

You have entitled your post 21 CFR Part 11 but you are asking a question about the validation of the WAN / LAN.

Couple of observations
1) Validation of a system (and potentially the qualification of your network) is a prerequisite to complying with 21 CFR Part 11.

2) Validation is not 21 CFR Part 11.
3) You will have a hard job validating / qualifying the WAN (internet).
4) Networks (LAN) are to be qualified in GxP environments.
5) Deal with network folder security and software applications validation & 21 CFR Part 11 based upon the software application and data relevant to the application.

This is breaking things down into managable chunks, with logical boundaries.

Do not try and bite the whole lot off in one and try and validate everything and try and get complinance with 21 CFR Part 11.

Not every software application in a GxP environment needs validating and not all GxP s/w applications need to comply with 21 CFR Part 11. Try using paper based solutions until your are ready to deal with 21 CFR Part 11.

There are post on this site that give links to network qualification guidance. There are also articles on the internet.

Regards
PaulS

Edited by PaulS on 08-06-08 11:26 AM. Reason for edit: No reason given.

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