IT (Computing) Discussion Forum

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

  Ilonka Schoester

  Dominique Chesnais (02/10/2020)

  2
• Validation of eRegulatory systems 'owned' by sites

  Brigid

  Brigid Flanagan (25/08/2020)

  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
• Electronic signatures - need for a validated system?

  Anon

  Dean Harris - DIGIT Committee Member (24/03/2020)

  2
• GxP Training for IT Dept

  Anon

  Peter Jackson (02/03/2020)

  2
• Wet ink and electronic signatures on the same document

  Anon

  MJ (12/07/2019)

  3
• eCRF data listings

  Ludmila Kutakova

  Ludmila Kutakova (18/06/2019)

  0
• Does an LMS need to be 21 CFR Part 11 compliant

  Michael

  Trev Simmons (DIGIT) (25/04/2019)

  4
• Inspection Dossier and Computer Systems

  JP

  Dympna Starling (29/03/2019)

  2
• Creating a QMS from the ground up

  Hannah

  GMP Committee (08/03/2019)

  5
• CTR implementation in UK and Europr

  Jan

  Anon (25/02/2019)

  3
• Use of SharePoint for eTMF?

  Jane Self

  Jane Self (14/02/2019)

  3
• Raw data as pdf

  Lynn

  Jane Self (13/02/2019)

  2
• (e)CRF archiving on site - copies of site data on CD/DVD

  Anon

  Colin Wilsher (29/01/2019)

  1

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