The quality document review process between pharmaceutical manufacturers and their contract partners is often manual and disjointed. Quality documents are often exchanged through email where their file sizes crash inboxes resulting in documents being split and sent as smaller files. In addition, there is often little visibility between the quality and supply chain functions with each often relying on phone calls and more emails for status. The end result is longer document review times causing missed commitment dates.
TraceLink’s Quality Review application provides pharmaceutical manufacturers and contract manufacturers with a secure, collaborative workspace to exchange reviews and commentary on quality documents including batch records, change controls, and deviations. With the appropriate permissions, users can see the commentary captured as part of the review cycle and receive notifications when documents have been commented on or moved to another stage in the review cycle.
With Quality Review you can:
- Upload and download quality documents without concern for file size constraints
- Link quality documents to other supply chain processes such as Purchase Orders or Work Orders
- Capture metrics associated with the quality document review process such as Right First Time and Document Review Cycle Time
- Receive email notifications when a document changes status or new commentary has been added