• Equipment register:
    calibration and maintenance requirements, accepted events with evidence, out of service and return to service.
  • Internal audits:
    programme-year plans, graded findings, responses, linked CAPAs and QA close-out.
  • Out-of-specification results:
    the original result, frozen at first submission, and a Phase I laboratory investigation with independent review.
  • Certificates and licences:
    a register with expiry dates, evidence and independent verification, shown in each employee's training file.
  • CAPA risk scores
    before and after corrective action.
  • Scheduled CAPA effectiveness checks
    , with a follow-on CAPA offered when a check fails.
  • Recurring quality tasks
    , with due-soon and overdue reminders for quality tasks.
  • Change controls:
    file attachments and a list of the documents a change will revise or retire.
  • Documents:
    approval is refused while another approval task is still pending, and an optional pane shows the actual approval status.
New capabilities are switched on per organization. Read the release notes.