Protect Patients Enable Health

Quality Review

Monitor, measure and control the quality review process for every project and partner in outsourced production.

Reduce Business Risk and Ensure Product Quality

  • Improve visibility into quality process activities through a central, shared quality review dashboard
  • Capture decision trail and supporting information
  • Track progress against product delivery promise dates
  • Exchange and track batch record, change control and event reviews between customer and contract partner
  • Maintain a shared view of open items, status and action tracking across the virtual production team
  • Receive alerts and when reviews are added, updated and completed

Reduce Quality Review Cycle Time

  • Use a consistent process for exchange and communication across all quality reviews between customer and contract partner
  • Receive alerts when reviews are added, updated and completed
  • Provide open access to the entire review communication trail, including associated notes and documents
  • Coordinate quality review processes with production and supply chain teams

Eliminate Delays and Proactively Identify Emerging Issues

  • Submit batch record and supporting documentation for team review
  • Coordinate reviews and and monitor progress against delivery plans
  • Identify when batch records have been viewed or modified
  • Link related change control and events to the batch record
  • Track batch record progress against product delivery promise date
  • Track right-first-time statistics, review cycle time and number of iterations required

Use Timely Information to Assess the Impact of Changes and Speed Closure

  • Track change control activities between customer and contract partner
  • Submit change control documents for review
  • View open change control items
  • Identify and track pending actions
  • Assess changes by month, type, product and other parameters

Use Timely Information to Assess the Impact of Events and Speed Closure

  • Track issues, incidents and deviations as they occur throughout the quality process
  • Link quality events to your batch record reviews
  • Track progress against product delivery promise dates
  • Review specific event information such as events by type, root cause, recurring events, etc.

Real-time Visibility into Quality Review Performance for All Supply Relationships

  • Automatically capture and share performance metrics with the virtual quality team
  • Analyze review times for batch records, event closures and other quality process activities
  • Analyze right-first-time batch record approvals, batch record review cycle times and number of iterations
  • Analyze changes by type, by customer and contract partner
  • Analyze events by type, root cause, recurrence, customer and contract partner

More Info

Video: How the TraceLink Network helps Accelerate Deviation Event Closure

Video: How the TraceLink Network helps Reduce Risk and Time in Quality Review

Video: How the TraceLink Network helps ensure Right-First-Time Order Fulfillment


Awards and Recognition

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