Securely Supply Every Global Market Opportunity
On-Time and In-Full

External Quality Management and Oversight

As production is outsourced and materials are sourced from global markets, it is harder than ever to ensure that product is produced at required quality levels, meets cGMP requirements and is delivered according to ever tightening delivery schedules.

To ensure quality, compliant product is produced on-time, in-full, you need:

  • Visibility and oversight across all external production and packaging operations
  • Close collaboration between internal and external quality management teams
  • Reduced reaction and closure times for batch record, change control and deviation event reviews
  • A real-time data exchange foundation to support PAT, Quality by Design and real-time release

Solution Vision

The TraceLink Business Cloud helps you create an integrated network quality management system incorporating CMOs, CPOs and other outsourced partners:

  • Shared visibility and collaboration on review of batch records, change controls, deviation events and investigations
  • Electronic capture and aggregation of CAPA, LIMS and process quality data in a common format
  • Point and click team collaboration ensures a common view on supply activities and improves response
  • Automatically calculated, real-time KPIs help identify performance trends and improves contract compliance

TraceLink Technology

Life Science companies and their trading partners can protect patient safety and secure revenue streams while ensuring regulatory compliance across a diverse set of geographic requirements and trade channel mandates:

  • Quality Review: Exchange of notes, documents, schedules and more in a user-managed, point-and-click collaborative team workspace
  • ProcessLink: User-managed, point-and-click team collaboration workspaces providing shared quality review visibility, notes and document information exchange and KPI dashboards
  • CAPA data exchange between integrated business systems
  • LIMS data exchange between integrated business systems
  • Process / batch data exchange between integrated business systems

Business Impact

  • Decrease time-to-market for product approvals and new product launches
  • Ensure rapid response and closure to quality events, investigations and product recalls
  • Reduce cost by improving efficiency and reducing work across external quality management processes
  • Reduce compliance risk by ensuring oversight across all external quality activities and improving the external quality management system