Manufacturers’ quality assurance issues lot or batch-bound Certificates of Analysis to their products actually manufactured. With regard to GMP (Good Manufacturing Practice) compliance, these certificates are used during transport as goods accompanying documents, especially in foreign trade as well as for security and control regulations. Their content lists the results of performed in-process tests or final inspections for approval, methods, and qualitative outcome. In addition, however, they also confirm that a regulated product meets its product specifications according to individual customer agreements. Without automation, the latter performance requirements can quickly lead to a significant use of your resources.
The solutions LineWorks SQM and LineWorks CQM offer the automated creation of electronic Certificates of Analysis (eCOA) which can flexibly be tailored to your individual customer requirements. The overall goal is the resource-saving drawing up of Certificates of Analysis and prompt availability of quality data on the entire supply chain. Approval processes for complete supply chains and for material movements will be streamlined such that just goods with proper standards will be in transit.
In conjunction with LineWorks SPACE as their backbone, LineWorks SQM and LineWorks CQM can fully show their potentials. The combination with the powerful online SPC system provides much more information, not only for supplier ratings or scorecards. You gain a much larger scope for your analyses, e.g. for correlations and Root Cause Analyses, with rules that, by determination, can trigger immediate countermeasures.