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About the 21 CFR PART 11 category
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0
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1253
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February 8, 2016
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Detection of endotoxin in vial washing M\c
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2
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1386
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August 26, 2020
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Validation for non CFR compliant equipment
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3
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2349
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June 20, 2018
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BMS and Pressure Differentials
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6
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2045
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June 19, 2018
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Are audit trails required to capture user logins?
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5
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2291
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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
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1588
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October 26, 2016
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Part 11 Compliance in ERP
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1
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2450
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May 3, 2016
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Electronic data backup
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1
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1841
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September 4, 2015
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Re-Authenticate to Validate the Signing Event
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4
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2028
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August 21, 2015
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21 CFR 11.10(f): Operational System Checks
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8
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4167
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May 29, 2015
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Correct approach for validation of laboratory equipments and software
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6
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1729
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May 26, 2015
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Is an Electronic Document deemed an Electronic Record
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2
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1356
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February 9, 2015
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Kaye Validator 2000 vs new narrow scope of FDA Part 11
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3
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2170
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October 2, 2014
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Validation Balance Calculation
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0
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1235
|
July 1, 2014
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To save or not to save? That is the crux of the conundrum
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0
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1141
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May 21, 2014
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What are minimum requirements for Maintaining an E-Record for Equipment Data
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3
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1294
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April 14, 2014
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Laboratory Systems - ER location and protection
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3
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1351
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April 7, 2014
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Does the audit trail need to contain the users role?
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4
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1472
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March 1, 2014
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Password Aging
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2
|
3009
|
February 25, 2014
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Equipment Process Parameters consider data?
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6
|
1643
|
January 27, 2014
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21 CFR Part 11 - use of Electronic Signatures
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5
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1700
|
December 9, 2013
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Electronic signature on several documents simultaneously
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1
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1290
|
November 15, 2013
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Some thoughts about SAP validation
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0
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1137
|
November 13, 2013
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Open and Closed System in Part11
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1
|
3860
|
October 16, 2013
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Using Adobe Acrobat Reader Version 10.1.0 to apply e-sigs to controlled docs & route
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1
|
1320
|
October 14, 2013
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Requesting recommendation for validation course
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1
|
1321
|
September 20, 2013
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Regulatory Compliance and Validation Issues
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0
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1140
|
February 18, 2013
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Validation requirements for SPL and other electronic submission tools/software
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0
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1083
|
January 7, 2013
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Electronic Authorization Request Form
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1
|
1213
|
December 6, 2012
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Barcode Scanners
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1
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1574
|
October 4, 2012
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