Real-time visibility into quality processes at your contract partners and direct and indirect material suppliers. Manage supplier issue submission, investigation, resolution, and closure. Track batch record review process for contract manufacturing and packaging and enable collaboration for quality documents including batch records, change controls, and deviations.
- Improved supplier performance. Visibility into current status of issues and quality documents to identify potential delays and bottlenecks.
- Better supplier relationships. Provide suppliers with visibility into internal processes so they can plan and meet your requirements.
- Reduced time to knowledge. Eliminate time required to find and collect information by centralizing data into a common platform.
- Linked view across production and quality processes. Visibility into impacts that delays in quality processes have on overcommitment dates and product availability.
- Continuous improvement. Capture key quality information to perform root cause analysis and identify opportunities for process improvements.
TraceLink’s Quality Management application provides a collaboration platform for batch record, change control, and deviations between pharmaceutical manufacturers and their contract partners. Quality Review documents posted in a secure, collaborative workspace accessible by each company's quality and operations team. Visibility is provided into the current status of the quality document review and links that status to the overall status of the manufacturing batch. Provides notification to all stakeholders when new documents and comments to documents are created. Tracks key performance metrics including Right First Time and Batch Record cycle time by supplier and supplier site.
Issue Tracking facilitates the exchange and tracking of supplier issues and complaints between the pharmaceutical company and their direct and indirect partners. Issue lifecycles are tracked from submission, investigation, and resolution through to closure. Issues are categorized so that detailed analysis can be performed supporting 8D (8 Disciplines) and Six Sigma DMAIC methods for root cause analysis and problem solving.
Change Management standardizes direct and indirect supplier change control processes and maintains them in a single repository. Suppliers can submit changes and change documentation and notify all stakeholders about the changes. Enables a standard process to communicate acknowledge and acceptance of a change or requests for additional information.