Quality Review
Monitor, measure and control the quality review process for every project and partner in outsourced production.
- Collaborate on Quality Reviews with Partners
- Build a Predictable, Repeatable Quality Review Process
- Track Batch Record Reviews
- Track Change Control
- Track Quality Events
- Shared KPI Dashboard
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