IT (Computing) Discussion Forum

• CRF (EDC - data + metadata) retention in dynamic file format.

  Anon

  ITC Committee (22/10/2021)

  1
• URS of LMS and LCMS

  Nayan Prajapati

  RQA GLP Committee (20/10/2021)

  7
• Validation Specifications Mapping

  Anon

  Anon (17/10/2021)

  0
• eQMS Systems - Lists, Reviews, Recommendations

  Eldin Rammell

  Eldin Rammell (14/10/2021)

  8
• EDC Audit Discovery

  Anon

  Anon (27/09/2021)

  5
• Access tocomputerised system by person who is admin and also user?

  Anon

  RQA GLP Committee (23/08/2021)

  1
• Need to audit providers like DocuSign or AdobeSign

  Anon

  Olga Stoll (19/07/2021)

  1
• GDPR and data saved on US servers

  Anon

  Colin Wilsher (16/07/2021)

  3
• SOP electronic systems

  Annon

  Annon (01/07/2021)

  0
• New EMS Draft guidance on computer systems in CT out for consultation

  Colin Wilsher

  Colin Wilsher (18/06/2021)

  0
• Modelling and Simulation database - regulatory requirements?

  Adnaan Mohamed

  Adnaan Mohamed (17/06/2021)

  6
• Regulatory inspection of a new to old LIMS based systems

  Anon

  RQA GLP Committee (14/05/2021)

  5
• eCRF UAT Screenshots

  Marci Murphy

  Tony Hewer (30/04/2021)

  1
• eCRF UAT Screenshots

  Marci Murphy

  Marci Murphy (29/04/2021)

  0
• Distributed Manufacturing

  Jennifer Bell

  Jennifer Bell (27/04/2021)

  0
• Computerised systems used to develope and to manufacture MD and IVD

  Ruth Lopez Magdaleno

  asleypatricia (31/03/2021)

  3
• China HGRAC and use of eDC

  Anon

  Anon (15/03/2021)

  0
• eSignatures - 11.100 (b)

  Kay Hague

  Kay Hague (18/02/2021)

  0
• eSignatures - 11.100(c)

  Kay

  Kay Hague (18/02/2021)

  1
• Compliance with NIST SP800-171

  Eldin Rammell

  Kay Hague (18/02/2021)

  1

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