About the 21 CFR PART 11 category
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0
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1401
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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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1709
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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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2523
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June 20, 2018
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BMS and Pressure Differentials
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6
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2254
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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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2529
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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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1693
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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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2598
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May 3, 2016
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Electronic data backup
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1
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1952
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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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2146
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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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4395
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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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1834
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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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1443
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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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2330
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October 2, 2014
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Validation Balance Calculation
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0
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1347
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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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1292
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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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1419
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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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1477
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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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1583
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March 1, 2014
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Password Aging
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2
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3301
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February 25, 2014
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Equipment Process Parameters consider data?
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6
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1769
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January 27, 2014
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21 CFR Part 11 - use of Electronic Signatures
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5
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1817
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December 9, 2013
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Electronic signature on several documents simultaneously
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1
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1418
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November 15, 2013
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Some thoughts about SAP validation
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0
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1266
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November 13, 2013
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Open and Closed System in Part11
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1
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3990
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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
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1443
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October 14, 2013
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Requesting recommendation for validation course
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1
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1434
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September 20, 2013
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Regulatory Compliance and Validation Issues
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0
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1254
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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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1217
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January 7, 2013
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Electronic Authorization Request Form
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1
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1324
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December 6, 2012
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Barcode Scanners
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1
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1817
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October 4, 2012
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