It'sQA offers a complete eTMF client and management solution incorporating subject matter expertise. A significant number of pharmaceutical and biotechnology companies already have a document management system that is integral to their daily operations. A number of these companies have extended their document management system to encompass elements of eTMF through either in-house customisation of their platform or through purchase of an external (vendor) eTMF solution.

It'sQA are able to present, consult, advise and provide learning with development for eTMF on the background of E2E on its basis within:

  • Support throughout the entire trial master file process, from planning through to archiving
  • Independent Vendor Selection Process support through to final client implementation 
  • Vendor Quality, Audit, Validation and Performance Quality within BS and ISO
  • Compliance and regulatory advice in accordance with MHRA, EMA & FDA – 21 CFR part 11
  • Advice on how to work within the industry DIA and TMF Reference Models
  • TMF Life Cycle Support
  • TMF Taxonomy with the 11 Zones
  • CRO capability

All essential TMF paper documentation can be maintained either at the client site or the chosen vendor offices. To date, we have worked with different eTMF systems, mostly based on SharePoint or Documentum.

Please feel free to contact us for an informal discussion about your eTMF requirements.