21 CFR PART 11

Topic	Replies	Views	Activity
Regulatory Compliance and Validation Issues	0	1302	February 18, 2013
Validation requirements for SPL and other electronic submission tools/software	0	1260	January 7, 2013
Electronic Authorization Request Form	1	1357	December 6, 2012
Barcode Scanners	1	1931	October 4, 2012
SharePoint and eSignature	0	1253	October 3, 2012
Existing system	7	1562	August 29, 2012
Requirement for Electronic Records	6	1269	August 25, 2012
"As Expected" vs Actual Results - During Test Script Execution	1	1680	August 24, 2012
An Easy to Understand Guide - Annex 11	0	1027	August 6, 2012
Vision Systems - E-Records or Not?	4	1091	July 19, 2012
An Easy to Understand Guide - 21 CFR PART 11	6	1370	July 16, 2012
Electronic Records – CSV FDA Warning Letters	0	987	June 26, 2012
E-signature in GMP document	10	4803	June 11, 2012
Compliance and Regulatory process during AMS of Life Science applications	0	711	March 28, 2012
21 CFR Part 11 – System Access to Authorized Individuals	0	833	March 16, 2012
Validation of Standalone systems	3	2006	March 15, 2012
Is Counterfeiting control regarded as cGMP	6	1357	March 13, 2012
Digital Vs Electronic Signature	3	1359	March 13, 2012
Spreadsheet Validation and Part11	10	1754	February 28, 2012
Good Distribution Practices	5	1313	August 24, 2011
Access Control Systems and 21 CFR Part 11	10	2558	August 24, 2011
Electronic Record Generation	5	1203	August 24, 2011
Pre-populated usernames	4	1048	August 24, 2011
Excel and Audit Trails	4	5170	June 14, 2011
Electronic Work Instruction (EWI)	9	1417	May 28, 2011
Software Installations on laptops by group other than Information Technology	1	807	March 22, 2011
Authoritation / sign	1	1026	March 16, 2011
Validation protocol and report	3	997	February 21, 2011
Validation for Sharepoint	5	2487	February 9, 2011
Spreadsheet Validation Issue	2	944	January 14, 2011