TraceLink (Woburn, MA), which has supplied online networking tools for, among others, contract packager Sharp Corp. (Allentown, PA) and contract manufacturers Catalent Pharma Solutions (Somerset, NJ) and Patheon (Research Triangle Park, NC), has expanded its service offerings into the quality-management sphere with Quality Review (QR). The expansion builds on the messaging and collaboration tools TraceLink has already built for managing relationships, specific to biopharma manufacturing, between CMOs and brand owners to initiate, schedule and monitor the many steps between a production run beginning and filing the necessary documentation for releasing production lots from one step to the next. By enabling this coordination, while cutting the expense of linking disparate enterprise systems among many brand owners and many CMOs, the goal of responsive, high-visibility supply chains can be achieved, says the company.

TraceLink has roots in the early days of drug pedigree programs, which enable similar coordination between trading partners to document shipment and transfer of commercial quantities of product. The founders, led by Shabbir Dahod, were also the founders of SupplyScape (which TraceLink later acquired, and still maintains the pedigree-documentation technology from then.)

The new QR package has these capabilities:

• Exchange, analysis and tracking of batch record, change control, event / incident and general quality reviews in a collaborative team workspace
• Integrated KPI dashboard providing real-time information on current and historical quality review performance
• Integrated communication and feedback trail, including comments and documents, for each iteration of the review cycle
• Alerts and status indicators that highlight when information has been submitted, viewed, modified or needs attention
• Quality review and production order linkage to increase insight into potential impacts of schedule or project changes.

“As outsourced production of pharmaceuticals increases, virtual quality teams struggle to efficiently monitor, measure and control quality review processes typically based on phone, fax and email communications,” said Dahod, CEO at TraceLink, “Quality Review is a quality information management service that connects quality teams across external supply relationships and ensures that all team members have access to the precise and timely information they need to reduce risk, ensure quality and meet production schedules.” PC