MasterControl Supplier Deviation BrochureSource: MasterControl
The supply chain for FDA-regulated companies poses many challenges. Suppliers are considered an extension of the company and thus must be shown to be FDA-compliant themselves. They have to be evaluated, audited and monitored. Their shipments have to be tested for compliance with a material’s specifications. Under very specific circumstances, exceptions from the written specifications can be made after appropriate review by the quality and engineering departments. However, waiting for this assessment until after the shipment has arrived at your loading dock puts undue pressure on your quality department and creates unnecessary costs in the event that a delivery is declined.
How can MasterControl help you?
Many of MasterControl’s regulated customers rely on our integrated suite to automate the process of collecting and controlling data critical to compliance. MasterControl Supplier Deviation creates a formal process where suppliers can request an exception to written specifications. Materials are shipped only after the appropriate individuals have reviewed and approved the request and provided proper justification.
The solution offers flexibility in terms of design, routing, and user and security roles to adjust to the way you work. It provides advanced tracking functionality, incorporates escalation, and offers best-practice features that prompt users with selected data to reduce data entry and avoid mistakes common in manual data entry. Captured data is stored in an ODBC-compliant database, enabling reporting and in-depth analysis through our powerful built-in Analytics tools.