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Writing & Executing a Software Validation Protocol: Plain and Simple

Writing & Executing a Software Validation Protocol: Plain and Simple


This quick and easy guide describes methods and approaches for writing a validation protocol that can help ensure a thorough validation effort. It also provides some tips and tricks on executing the protocol and documenting the results.

While this book was written primarily for those new to validation projects and the effort required gathering sufficient evidence to support validation claims , experienced folks will likely find nuggets to help improve their efforts.



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Threads 1 to 30 of 38

Forum: SCADA & PLC's

Is it Software ? Is it Firmware - The Debate goes on!

    • Replies: 0
    • Views: 956
    10-18-2012, 03:58 PM Go to last post
  1. Unhappy Help about BMS (SCADA) requalification

    Started by slavica, 08-29-2012 09:07 AM
    • Replies: 2
    • Views: 637
    09-05-2012, 09:35 AM Go to last post
  2. PLC Change Control Management

    Started by Loneaaz, 03-16-2012 02:16 AM
    • Replies: 1
    • Views: 1,421
    03-22-2012, 12:20 PM Go to last post
  3. SCADA add on software

    Started by adam, 12-13-2011 04:38 AM
    automation, industrial, scada, schneider, software
    • Replies: 1
    • Views: 1,214
    12-13-2011, 02:52 PM Go to last post
  4. Audit-Trail uses electronic signatures?

    Started by gabrielgarate, 08-23-2011 08:27 PM
    • Replies: 3
    • Views: 1,904
    09-06-2011, 07:39 AM Go to last post
  5. Qualification vision system

    Started by marcos, 08-31-2011 05:13 PM
    • Replies: 0
    • Views: 1,071
    08-31-2011, 05:13 PM Go to last post
  6. Is necessary the CRC test for data integrity

    Started by gabrielgarate, 07-15-2011 07:38 PM
    • Replies: 0
    • Views: 1,494
    07-15-2011, 07:38 PM Go to last post
  7. Question Server Qualification after move

    Started by jpence, 12-19-2007 09:01 PM
    • Replies: 4
    • Views: 3,242
    06-21-2011, 12:28 PM Go to last post
  8. Unhappy Gamp 5

    Started by prashant.chawla, 05-07-2010 06:53 AM
    • Replies: 5
    • Views: 2,780
    04-30-2011, 04:10 AM Go to last post
  9. plc training in chennai

    Started by sureshkrish, 01-11-2011 09:34 AM
    plc training in chennai
    • Replies: 1
    • Views: 1,458
    04-07-2011, 04:52 AM Go to last post
  10. BMS Continuum Software Upgrade

    Started by bvalidation, 03-22-2011 12:31 PM
    • Replies: 1
    • Views: 1,104
    03-22-2011, 04:22 PM Go to last post
  11. Plc Training Iin India

    Started by piyushgrace, 02-11-2011 05:55 AM
    • Replies: 0
    • Views: 1,016
    02-11-2011, 05:55 AM Go to last post
  12. PLC validation problem

    Started by eng1, 03-22-2007 07:34 AM
    • Replies: 9
    • Views: 3,921
    01-31-2011, 04:59 AM Go to last post
  13. Lab Equipment Integration

    Started by Mark Richardson, 01-26-2011 12:38 PM
    ebr, ioq, lab equipment, mbr, mes, ple
    • Replies: 0
    • Views: 1,460
    01-26-2011, 12:38 PM Go to last post
  14. Source Code Reviewing

    Started by Mark Richardson, 01-25-2011 04:48 PM
    dynamic analysis, instrumenting code, review, source code
    • Replies: 1
    • Views: 1,041
    01-25-2011, 09:11 PM Go to last post
  15. Embedded HMI compliance with 21 CFR Part 11

    Started by sagar, 07-27-2009 04:23 AM
    • Replies: 3
    • Views: 2,062
    01-10-2011, 09:43 AM Go to last post
  16. BMS/EMS Qualification

    Started by waynem, 04-29-2008 11:57 AM
    • Replies: 10
    • Views: 6,728
    11-29-2010, 08:50 PM Go to last post
  17. CFR 21 Pt 11 audit trails

    Started by keda, 05-24-2010 11:36 AM
    • Replies: 2
    • Views: 2,443
    08-24-2010, 07:51 AM Go to last post
  18. Documentation from Vendors

    Started by gokeeffe, 05-28-2008 09:50 AM
    • Replies: 7
    • Views: 3,098
    05-28-2010, 01:56 PM Go to last post
  19. The difference between a FAT and a SAT

    Started by gokeeffe, 04-15-2010 09:24 AM
    • Replies: 0
    • Views: 1,309
    04-15-2010, 09:24 AM Go to last post
  20. Network Qualification

    Started by yogibear, 01-28-2008 02:25 PM
    • Replies: 3
    • Views: 3,132
    02-10-2010, 06:52 AM Go to last post
  21. Distributed Control System Validation

    Started by rajinderkaur, 12-17-2009 06:24 AM
    • Replies: 1
    • Views: 1,911
    01-18-2010, 11:17 PM Go to last post
  22. PLC validation - Periodic Revalidation

    Started by vamsemicro, 02-29-2008 10:19 AM
    • Replies: 9
    • Views: 4,174
    12-07-2009, 08:56 PM Go to last post
  23. MES Category

    Started by shan_amudha, 11-19-2009 08:34 AM
    • Replies: 0
    • Views: 1,383
    11-19-2009, 08:34 AM Go to last post
  24. Validation of PLC based Automation

    Started by maryacton, 04-23-2007 07:16 AM
    • Replies: 7
    • Views: 8,200
    09-05-2009, 11:45 PM Go to last post
  25. Question SDS/SMDS for a SCADA/PLC System

    Started by gabrielgarate, 06-09-2009 11:07 PM
    • Replies: 6
    • Views: 2,575
    06-16-2009, 01:33 PM Go to last post
  26. MES upgrade

    Started by msba90@eircom.net, 11-26-2008 11:16 AM
    • Replies: 1
    • Views: 1,932
    11-26-2008, 03:17 PM Go to last post
  27. SCADA/PLC software validation

    Started by shan_amudha, 11-05-2008 10:26 AM
    • Replies: 2
    • Views: 4,146
    11-06-2008, 12:30 AM Go to last post
  28. Moving Servers

    Started by chandra, 02-22-2008 07:34 AM
    • Replies: 1
    • Views: 1,770
    02-22-2008, 07:35 AM Go to last post
  29. Autoclave cold spot, any advice!

    Started by gokeeffe, 11-05-2007 04:16 PM
    • Replies: 14
    • Views: 5,775
    01-25-2008, 02:33 PM Go to last post

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