Product-Centric QMS: A Critical Advantage for Regulated Companies

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