System/Technical Requirements

  • Standard Trial Interactive browser requirements apply to the Quality Management System Solution.
  • It is assumed that the system has no practical limit to the number of authorized users who are asked to create incidents/documents and/or are accessing them within the room.
  • This solution can have GlobalLink Translations available to easily request a certified translation of any documentation if enabled with document management.
  • This solution has the ability to perform Quality Review for oversight if enabled with document management.

High level technical capabilities:

  • Users can view, modify metadata on incidents within a workflow, if desired and configured.
  • Users can run reports on Inventory, KPIs, User Access.
  • Ability to access Audit Trail.
  • Ability to add or remove user access.
  • Ability to designate personnel as required to perform activities in the system related to incident response and workflow activities.
  • Ability to send queries via built in email mechanism to one or multiple personnel, with tracking in the communications outbox module.
  • Users can Copy/move documents between rooms, if desired and configured.
  • Users can perform translation requests for certified translations, if desired and configured.

Solutions available for interoperability:

  • GlobalLink Translations Portal
  • QDMS
  • CTMS
  • GlobalLearn
  • TI Connector
  • eTMF
  • eISF