Are you looking for compliance related literature?

PENSA is building a library of documents from various sources, including the FDA. Please use this site as a resource for all of your compliance information. 

If you have suggestions about information you would like to see stored here and available for your industry peers, please drop a note to PENSA@gmps.com.

Currently, PENSA's library contains the following documents:

• Technical Considerations for the Validation of Electronic Spreadsheets for Complying with 21 CFR Part 11 by Tuan T. Phan.
  Published in Pharmaceutical Technology, January 2003
   

• Effective Standard Operating Procedures in a Regulatory Environment by Erica Charlton. 
  Published in Pharmaceutical Engineering, July/ August 2003
   

• 21 CFR Part 11 Final Rule (a Searchable pdf file) from the FDA.
   

• Instituting a Risk-based Plan for Part 11 Compliance by Robert W. Stotz, of Validation Technologies, Inc., March 2003.