Computing Discussion Forum

• 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
• Electronic Signatures

  Bert

  bert (21/06/2018)

  2
• Does an LMS need to be 21 CFR Part 11 compliant

  Michael

  Matt Jones - Chair, DIGIT Committee (03/06/2018)

  1
• Inspection Dossier and Computer Systems

  JP

  Matt Jones - Chair, DIGIT Committee (03/06/2018)

  1
• 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
• Clinical Trial Management System

  MS

  Jhone samar (03/02/2018)

  7
• URS of LMS and LCMS

  Nayan Prajapati

  Nayan Prajapati (20/12/2017)

  0
• Is the use of cloud storage services compliant with the principles of GLP?

  Graham Small

  RQA GLP Committee (29/11/2017)

  1
• Cloning Hard-drives For Disaster Recovery

  Steven Reilly

  Graham Ogg (17/10/2017)

  1
• eConsent

  Rachana

  Rachana (03/07/2017)

  0
• Software Validation

  Diana Pádua

  Diana Pádua (23/03/2017)

  2
• Archiving of GLP studies

  LM

  Michael (22/02/2017)

  0
• Extent of Validation for customer of SaaS and COTS solutions

  Michael Noble

  Michael Noble (02/02/2017)

  0
• Contract/SLA requirements for SaaS vendors

  David

  David (25/01/2017)

  0
• URS for CAPA

  Mariem Sarghini

  Chris (19/01/2017)

  1
• Validating one process in a computer system

  Rick Mooney

  Chris (19/01/2017)

  1

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