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QMS

  • Preconfigured QMS structure
  • Controlled document management
  • Integrated CAPA, Audit, x-train™
  • SOP template library
  • Change Control + publishing

R&D

  • Configuration for eTMF and Submissions
  • Supports authored record documents
  • DIA Reference model supported simply

Integrations

  • Adlib .pdf publishing
  • CoSign Digital Signatures
  • Invu scanning/OCR & routing
  • Migration support

x-train™

  • Compliant training management
  • Testing assessment certification
  • Linked to QMS
  • Training KPI's viewable for managers
  • Trainees & Instructors managed

Due Diligence

  • Access and permission management
  • e-record control
  • Site builder for local configuration support

Forms Based Processes

  • CAPA
  • Change Control
  • Deviation Management
  • OoS result
  • Complaints & Investigations
  • Audit Management