Computing Discussion Forum

• 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
• Wet ink and electronic signatures on the same document

  Anon

  Anon (28/02/2019)

  2
• 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
• Electronic Signatures

  Bert

  elma asheley (03/01/2019)

  3
• Clinical Trial Management System

  MS

  Ajay Bosamiya (25/12/2018)

  9
• 'Simple' electronic signatures

  Nikki Cooper

  Anon (27/11/2018)

  1
• Computerised system admin

  Anon

  RQA GLP Committee (20/11/2018)

  1
• Procurement

  Nishant

  Nishant (08/10/2018)

  0
• System Validation Reports Filed to TMF

  Ferenc

  Matthew Jones - Chair DIGIT Committee (14/08/2018)

  3
• Trace the Freezer Temperature through Wireless System

  Harold

  RQA GLP Committee (03/07/2018)

  4
• Can an open source system be validated?

  Sally Hughes

  Sally Hughes (15/05/2018)

  0
• New Laboratory Information System

  Anon

  RQA GLP Committee (30/04/2018)

  1
• EU Requirement for EDC systems backup in countries where study being conducted?

  Janice Sarasola

  Matt Jones - Chair DIGIT Committee (18/04/2018)

  1
• Non validated computerized system

  Ludmila Kutakova

  Ludmila Kutakova (13/02/2018)

  0
• URS of LMS and LCMS

  Nayan Prajapati

  Nayan Prajapati (20/12/2017)

  0

Share your experience on trustpilot.com