|
About the 21 CFR PART 11 category
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0
|
1126
|
February 8, 2016
|
|
Detection of endotoxin in vial washing M\c
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2
|
1098
|
August 26, 2020
|
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Validation for non CFR compliant equipment
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3
|
2152
|
June 20, 2018
|
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BMS and Pressure Differentials
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6
|
1871
|
June 19, 2018
|
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Are audit trails required to capture user logins?
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5
|
2157
|
April 30, 2017
|
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8 Essential Tips to Prevent Unauthorized System Access – 21 CFR Part 11 [Video]
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0
|
1448
|
October 26, 2016
|
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Part 11 Compliance in ERP
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1
|
2264
|
May 3, 2016
|
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Electronic data backup
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1
|
1726
|
September 4, 2015
|
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Re-Authenticate to Validate the Signing Event
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4
|
1843
|
August 21, 2015
|
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21 CFR 11.10(f): Operational System Checks
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|
8
|
3937
|
May 29, 2015
|
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Correct approach for validation of laboratory equipments and software
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6
|
1576
|
May 26, 2015
|
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Is an Electronic Document deemed an Electronic Record
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2
|
1244
|
February 9, 2015
|
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Kaye Validator 2000 vs new narrow scope of FDA Part 11
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3
|
1959
|
October 2, 2014
|
|
Validation Balance Calculation
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0
|
1091
|
July 1, 2014
|
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To save or not to save? That is the crux of the conundrum
|
|
0
|
1007
|
May 21, 2014
|
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What are minimum requirements for Maintaining an E-Record for Equipment Data
|
|
3
|
1170
|
April 14, 2014
|
|
Laboratory Systems - ER location and protection
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|
3
|
1217
|
April 7, 2014
|
|
Does the audit trail need to contain the users role?
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|
4
|
1333
|
March 1, 2014
|
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Password Aging
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|
2
|
2726
|
February 25, 2014
|
|
Equipment Process Parameters consider data?
|
|
6
|
1518
|
January 27, 2014
|
|
21 CFR Part 11 - use of Electronic Signatures
|
|
5
|
1550
|
December 9, 2013
|
|
Electronic signature on several documents simultaneously
|
|
1
|
1163
|
November 15, 2013
|
|
Some thoughts about SAP validation
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|
0
|
1021
|
November 13, 2013
|
|
Open and Closed System in Part11
|
|
1
|
3733
|
October 16, 2013
|
|
Using Adobe Acrobat Reader Version 10.1.0 to apply e-sigs to controlled docs & route
|
|
1
|
1196
|
October 14, 2013
|
|
Requesting recommendation for validation course
|
|
1
|
1174
|
September 20, 2013
|
|
Regulatory Compliance and Validation Issues
|
|
0
|
1030
|
February 18, 2013
|
|
Validation requirements for SPL and other electronic submission tools/software
|
|
0
|
963
|
January 7, 2013
|
|
Electronic Authorization Request Form
|
|
1
|
1116
|
December 6, 2012
|
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Barcode Scanners
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|
1
|
1326
|
October 4, 2012
|
