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Qualification & Validation (Also 21 CFR Part 11)

Qualification & Validation (Also 21 CFR Part 11)

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  1. Rick Is

    Qualified File Storage - Computer System Validation

    Rick Is, Apr 15, 2022
    Replies:
    3
    Views:
    5,926
    BradM
    Apr 19, 2022
  2. sksanstuff

    Label Printer Software

    sksanstuff, Feb 28, 2016
    Replies:
    5
    Views:
    4,787
    ET18223
    Dec 17, 2020
  3. MarkMeer

    UDI - barcode & matrix verification options

    MarkMeer, May 16, 2016
    Replies:
    8
    Views:
    4,740
    MarkMeer
    Jun 10, 2016
  4. TheWaeller

    Need to Validate "off the shelf" Statistical Software Packages ?

    TheWaeller, Feb 17, 2016
    Replies:
    4
    Views:
    4,674
    Bev D
    Feb 17, 2016
  5. Candi1024

    CNC Software Validation & Change Control

    Candi1024, Aug 27, 2015
    Replies:
    3
    Views:
    3,810
    JAltmann
    Sep 3, 2015
  6. SoccSu8912

    Validate Hand Tools

    SoccSu8912, Mar 5, 2019
    Replies:
    8
    Views:
    2,483
    Richard Billings
    Apr 4, 2019
  7. Rupesh

    Cleaning Validation Master Plan

    Rupesh, Sep 7, 2017
    Replies:
    1
    Views:
    2,431
    Micheli Lermen
    Jun 14, 2018
  8. Bates74

    How to cross/break an azeotrope?

    Bates74, Sep 13, 2021
    Replies:
    1
    Views:
    2,119
    Andy Nichols
    Sep 13, 2021
  9. Candi1024

    Thinking through a process validation

    Candi1024, Mar 31, 2016
    Replies:
    7
    Views:
    1,915
    Ronen E
    Apr 16, 2016
  10. leomac83

    OQ and CPP

    leomac83, Jun 28, 2020
    Replies:
    1
    Views:
    1,906
    leomac83
    Nov 3, 2020
  11. mdfi13

    Part 11 and Electronic Signatures

    mdfi13, Apr 13, 2017
    Replies:
    3
    Views:
    1,859
    yodon
    Apr 17, 2017
  12. jojo63

    Mold qualification on different machines

    jojo63, Jan 11, 2016
    Replies:
    6
    Views:
    1,857
    jojo63
    Oct 28, 2016
  13. Micheli Lermen

    ISO (80002)

    Micheli Lermen, Jul 16, 2018
    Replies:
    2
    Views:
    1,709
    Micheli Lermen
    Jul 16, 2018
  14. Abdullah

    Documentation of validation and qualification protocols

    Abdullah, Jan 11, 2016
    Replies:
    9
    Views:
    1,638
    Abdullah
    Jan 19, 2016
  15. Abdullah

    Validation master plan

    Abdullah, Jan 17, 2016
    Replies:
    3
    Views:
    1,620
    Abdullah
    Jan 19, 2016
  16. Jennie

    Departmental Roles in equipment qualification

    Jennie, Jan 19, 2016
    Replies:
    4
    Views:
    1,483
    Candi1024
    Dec 7, 2016
  17. leomac83

    Good Process Validation book to recommend

    leomac83, Apr 2, 2021
    Replies:
    2
    Views:
    1,469
    leomac83
    Sep 12, 2021
  18. PaMark

    Release of products from trials

    PaMark, Apr 19, 2016
    Replies:
    1
    Views:
    1,127
    QAengineer13
    Apr 22, 2016
  19. Eóin McMahon

    Granting user acces to GMP production systems

    Eóin McMahon, Jan 16, 2020
    Replies:
    1
    Views:
    1,123
    yodon
    Jan 16, 2020
  20. Airwolf

    IQ and OQ for assembled machine

    Airwolf, Oct 29, 2019
    Replies:
    2
    Views:
    1,026
    Airwolf
    Nov 6, 2019
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