pharma implementation USFDA ---21 CFR Part 11

[Former Member]

Hi All,

Has anybody worked on Pharma implementation which includes entire software validation process including USFDA 21CFRPart11.

If yes please let me know what it is all about.

with regards,

Raghu

[oliver_nuernberg · Accepted solution]

Hi,

we have implemented SAP in numerous accounts where FDA-regulated processes have been part of the project and therefore Part 11 applies.

If you have access to the <a href="http://www.sap.com/sapphire">SAPPHIRE</a> history, you can see some presentations about implementations at customers that include validation (in the FDA sense) of the implemented solution.

Probably the best introductory document is the Part 11 whitepaper which is available on www.sap.com :

<a href="http://download.sap.com/download.epd?context=350C36E2AD32CCFA36DC79DA781757790DDBF824DFC6C128F28E92887B5AC3CB2752FFF9D79B09F13CF74B15BC1C9720E039264EDF50383B">"Complying with U.S. FDA Title 21 CFR Part 11 for the Life Sciences Industry"</a>

In general, check out sap.com --> Industries --> Life Sciences. There is a lot of helpful information on compliance in general and 21 CFR Part 11 in particular.

i hope this helps....if so award my first points !!

Thanks.

Oliver

[Former Member]

Hi,

Go through this

<u>http://www.invensys-vt.com/us/eng/Regulations/usfda/21CFRPart+11/21cfrpart11.htm</u>

<u>http://www.ccpie.org/news/jishu/cfr.ppt</u>

<u>http://www.primetechpa.com/additional_compliance.htm?OVRAW=USFDA%20---21%20CFR%20Part%2011&OVKEY=21%20cfr%20part%2011&OVMTC=advanced</u>

Mohan

[Former Member]

Hi,

Please check these links.

<a href="http://www.21cfrpart11.com/pages/faq/index.htm">21cfrpart11 information</a>

As well pl check this site for more info companies who followed these guidelines.

<a href="http://www.nc-india.com/centrefolds/stories/64147.html">Link 2</a>

Hope this gives some useful information. Please reward if useful.

Thanks & Regards

Sadhu Kishore