Product-Centric QMS: A Critical Advantage for Regulated Companies

What Arena Does Better Than Document-Centric QMS

Product Centric QMS with Arena

Product-Centric QMS Benefits and Functionality

Provides Enterprise-Wide Visibility

  • Captures everything required to design, produce, and ship product for all teams—a single source of product truth
  • Provides controlled access for the entire enterprise, including supply chain, for collaboration

Unifies Quality and CAPA Process With the Product Record

  • Links CAPA records with the product record and engineering changes (e.g., ECRs, ECOs, deviations)

Facilitates Quality Considerations During the Product Development Cycle

  • Reuses approved manufacturers’ parts and other purchased subassemblies
  • Manages dynamic links between all components, quality issues, and documents to help engineering prevent recurring quality problems

Simplifies Enterprise Software System Validation

  • Documents validation test results for every product upgrade to subscribers
  • Eliminates the fear of upgrading whenever new functionality is available (known as “revision lock”)

Reduces Internal and External Audit Time

  • Links and indexes entire product record, including the DMR and DHF, for easy searching