IT (Computing) Discussion Forum

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

  Ruth Lopez Magdaleno

  asleypatricia (31/03/2021)

  3
• eQMS Systems - Lists, Reviews, Recommendations

  Eldin Rammell

  Willi Ramseier (24/03/2021)

  5
• 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
• [FREE]: US FDA CDER Small Business and Industry Assistance (SBIA) Learn Online Training Repository

  Aldwin Aldana

  Aldwin Aldana (16/02/2021)

  0
• Zipping of Data Files/Folders for Archiving

  Anon

  RQA GLP Committee (15/02/2021)

  2
• Recommendations for companies providing elearning modules to purchase for upload into our company LMS

  Lou

  Aldwin Aldana, MS, RQAP-GLP, MRQA (01/12/2020)

  5
• Validation of eRegulatory systems 'owned' by sites

  Brigid

  Willi Ramseier (27/11/2020)

  5
• Does an LMS need to be 21 CFR Part 11 compliant

  Michael

  Anon (27/11/2020)

  5
• Are there any regulations that define whether an audit trail should be stored together with the data??

  Ilonka Schoester

  Willi Ramseier (27/11/2020)

  3
• Minimal requirements for eSignature in GCP

  anon

  Dean Harris - IT Committee Member (26/11/2020)

  4
• Electronic Signatures

  Bert

  Anon (30/07/2020)

  16
• Validation of a Scanning Process (Cert. Copy)

  Anon

  Colin Wilsher (02/07/2020)

  2
• GxP Mobile Apps

  Natalia

  Natalia (01/06/2020)

  3
• eCRF distribution to site

  Martin Miller

  Dominique Chesnais (28/05/2020)

  2
• eCRF development and testing

  Phil Gardiner

  Olga Stoll (IT Committee) (07/05/2020)

  1
• Windows 7 OS

  Julie

  Archie (14/04/2020)

  2
• 'Simple' electronic signatures

  Nikki Cooper

  Nikki Cooper (06/04/2020)

  4

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