|
About the 21 CFR PART 11 category
|
|
0
|
1339
|
February 8, 2016
|
|
Detection of endotoxin in vial washing M\c
|
|
2
|
1532
|
August 26, 2020
|
|
Validation for non CFR compliant equipment
|
|
3
|
2432
|
June 20, 2018
|
|
BMS and Pressure Differentials
|
|
6
|
2150
|
June 19, 2018
|
|
Are audit trails required to capture user logins?
|
|
5
|
2391
|
April 30, 2017
|
|
8 Essential Tips to Prevent Unauthorized System Access – 21 CFR Part 11 [Video]
|
|
0
|
1648
|
October 26, 2016
|
|
Part 11 Compliance in ERP
|
|
1
|
2540
|
May 3, 2016
|
|
Electronic data backup
|
|
1
|
1903
|
September 4, 2015
|
|
Re-Authenticate to Validate the Signing Event
|
|
4
|
2095
|
August 21, 2015
|
|
21 CFR 11.10(f): Operational System Checks
|
|
8
|
4297
|
May 29, 2015
|
|
Correct approach for validation of laboratory equipments and software
|
|
6
|
1786
|
May 26, 2015
|
|
Is an Electronic Document deemed an Electronic Record
|
|
2
|
1404
|
February 9, 2015
|
|
Kaye Validator 2000 vs new narrow scope of FDA Part 11
|
|
3
|
2271
|
October 2, 2014
|
|
Validation Balance Calculation
|
|
0
|
1300
|
July 1, 2014
|
|
To save or not to save? That is the crux of the conundrum
|
|
0
|
1220
|
May 21, 2014
|
|
What are minimum requirements for Maintaining an E-Record for Equipment Data
|
|
3
|
1366
|
April 14, 2014
|
|
Laboratory Systems - ER location and protection
|
|
3
|
1429
|
April 7, 2014
|
|
Does the audit trail need to contain the users role?
|
|
4
|
1540
|
March 1, 2014
|
|
Password Aging
|
|
2
|
3182
|
February 25, 2014
|
|
Equipment Process Parameters consider data?
|
|
6
|
1723
|
January 27, 2014
|
|
21 CFR Part 11 - use of Electronic Signatures
|
|
5
|
1763
|
December 9, 2013
|
|
Electronic signature on several documents simultaneously
|
|
1
|
1357
|
November 15, 2013
|
|
Some thoughts about SAP validation
|
|
0
|
1214
|
November 13, 2013
|
|
Open and Closed System in Part11
|
|
1
|
3939
|
October 16, 2013
|
|
Using Adobe Acrobat Reader Version 10.1.0 to apply e-sigs to controlled docs & route
|
|
1
|
1391
|
October 14, 2013
|
|
Requesting recommendation for validation course
|
|
1
|
1389
|
September 20, 2013
|
|
Regulatory Compliance and Validation Issues
|
|
0
|
1212
|
February 18, 2013
|
|
Validation requirements for SPL and other electronic submission tools/software
|
|
0
|
1162
|
January 7, 2013
|
|
Electronic Authorization Request Form
|
|
1
|
1281
|
December 6, 2012
|
|
Barcode Scanners
|
|
1
|
1720
|
October 4, 2012
|