21 CFR PART 11

Topic	Replies	Views	Activity
SharePoint and eSignature	0	1228	October 3, 2012
Existing system	7	1532	August 29, 2012
Requirement for Electronic Records	6	1241	August 25, 2012
"As Expected" vs Actual Results - During Test Script Execution	1	1648	August 24, 2012
An Easy to Understand Guide - Annex 11	0	1006	August 6, 2012
Vision Systems - E-Records or Not?	4	1061	July 19, 2012
An Easy to Understand Guide - 21 CFR PART 11	6	1317	July 16, 2012
Electronic Records – CSV FDA Warning Letters	0	964	June 26, 2012
E-signature in GMP document	10	4763	June 11, 2012
Compliance and Regulatory process during AMS of Life Science applications	0	677	March 28, 2012
21 CFR Part 11 – System Access to Authorized Individuals	0	793	March 16, 2012
Validation of Standalone systems	3	1968	March 15, 2012
Is Counterfeiting control regarded as cGMP	6	1330	March 13, 2012
Digital Vs Electronic Signature	3	1316	March 13, 2012
Spreadsheet Validation and Part11	10	1713	February 28, 2012
Good Distribution Practices	5	1282	August 24, 2011
Access Control Systems and 21 CFR Part 11	10	2488	August 24, 2011
Electronic Record Generation	5	1177	August 24, 2011
Pre-populated usernames	4	1024	August 24, 2011
Excel and Audit Trails	4	5135	June 14, 2011
Electronic Work Instruction (EWI)	9	1371	May 28, 2011
Software Installations on laptops by group other than Information Technology	1	777	March 22, 2011
Authoritation / sign	1	999	March 16, 2011
Validation protocol and report	3	970	February 21, 2011
Validation for Sharepoint	5	2432	February 9, 2011
Spreadsheet Validation Issue	2	909	January 14, 2011
UK/European 21CFR Part 11 Equivalence	2	2733	December 27, 2010
What is GxP and what are predicate rules?	2	2581	December 27, 2010
3 consecutive batches requirement	10	2513	December 21, 2010
Peak purity,Purity Angle,Purity Threshold and Purity Flag	0	2711	September 30, 2010