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.
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MasterControl Document Connections allows companies the ability to integrate their existing electronic repositories like Electronic Content Management ECM and Product Lifecycle Management PLM systems, manufactured by software vendors like Documentum™ and Agile™ with MasterControl Training™, MasterControl CAPA™, MasterControl Forms™, and other cutting-edge MasterControl applications. By using this module, integration of MasterControl solutions with external repositories can be made easily and immediately, without expensive custom coding.
MasterControl considers validation an integral part of software solutions for FDA-regulated customers. Our "continuous validation" approach dramatically cuts the time, pain, and cost involved in validation, making it easier to re-validate future upgrades.
MasterControl's continuum of products and services address different levels of validation needs based on individual risk assessment. They include innovative products and services such as MasterControl Transfer OQ and MasterControl Automated OQ.
Here is how MasterControl addresses common challenges in managing electronic repositories that are not connected to quality processes:
MasterControl Document Connections Software
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.
Lacks Process-Specific Functionality
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.
Allows Integration with Process-Specific Applications
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.
MasterControl Document Connections, a part of the MasterControl integrated quality management suite, is an innovative solution designed to help companies leverage their existing repositories for a holistic, compliant, and cost-effective quality management system.
A key element of this solution is the use of Surrogate InfoCards. The InfoCard is the MasterControl tool that summarizes information about every document in the system and serves as a placeholder for the document in the database. Every item in a repository will have a corresponding Surrogate InfoCard in MasterControl Document Connections. Surrogate InfoCards allow communication between the repository and MasterControl Connections, which then leads to an appropriate action in MasterControl Training, MasterControl CAPA, or other MasterControl applications. Below are the highlights of this solution.
Document Change Triggers Action - When a revised document (e.g. SOP, work instructions, etc.) in a repository is approved, MasterControl will trigger related tasks in the MasterControl application that has been integrated with the repository. For example, MasterControl Training tasks can be automatically sent to affected trainees when the document is revised in the connected repository.
Linking of Documents - A document in a repository can be linked to a MasterControl form for a streamlined workflow. For example, a new SOP is approved and released in a repository. When a CAPA, change request, customer complaint, or other type of form related to this particular SOP is launched in the MasterControl system, a link can be made to the corresponding SOP. This enables the participants to have easy access to the SOP that exists in an alternate repository.
Multiple Document Connections - Multiple connections can be made to multiple repositories. This is beneficial for those companies that may have documents stored in multiple repositories (e.g., SOPs in one and engineering drawings in another), but would like to trigger training when changes occur in either.