Most companies in FDA and ISO environments rely heavily on electronic repositories to store, manage, and control standard operating proceedures (SOP), engineering drawings, forms, work instructions, and other documents necessary for compliance. They might have invested substantial amounts in document management technology before realizing their other needs, such as training control and handling of corrective/preventive action (CAPA), which cannot be managed by repositories — even very expensive ones.
|Download Free Resources|
Electronic repositories that function separately from quality processes (CAPA, training control, etc.) are likely to cause some inefficiency. Disconnected processes also increase the likelihood of quality issues falling through the cracks.
Connecting electronic repositories with quality processes fosters efficiency and also ensures that quality issues are handled in a timely manner. This connectivity allows a holistic and proactive approach to quality management.
While electronic repositories are useful for document management, they don't have the ability to control specific quality processes that are critical to regulatory compliance.
Through MasterControl Document Connections, companies can complement their existing repositories with MasterControl's powerful, process-specific applications for managing training, CAPA, audit, change control, customer complaints, nonconformance, and other quality processes.
A company that has made a significant financial investment in an electronic repository expects to use the system for a number of years. Buying a new system that renders the existing repository useless means a loss on the initial investment.
MasterControl can integrate a repository with MasterControl quality management applications without the need for expensive custom coding. With this solution, an existing repository need not turn into a white elephant.