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.
PENSA's library contains
the following documents:
Considerations for the Validation of Electronic
Spreadsheets for Complying with 21 CFR Part 11
by Tuan T. Phan.
Published in Pharmaceutical Technology,
Standard Operating Procedures in a Regulatory
by Erica Charlton.
Published in Pharmaceutical
Engineering, July/ August 2003
CFR Part 11 Final Rule
(a Searchable pdf file) from the FDA.
a Risk-based Plan for Part 11 Compliance
by Robert W. Stotz, of Validation
Technologies, Inc., March 2003.