In previous posts, we’ve discussed how quality management is more than just about being in compliance, and how an enterprise quality management system (EQMS) can be leveraged to proactively prevent expensive product recalls. As quality professionals, we can also recognize that quality management can be complex, encompassing a set of processes, procedures and controls that extend throughout an organization.
A manufacturing organization often needs to manage and control an intricate web of quality events, any one of which potentially generates numerous parallel or sequential actions. For example, a deviation might occur in a manufacturing process. That deviation must be tracked, investigated, and corrected as needed. A variety of business stakeholders are engaged and informed of the progress and eventual resolution. By automating quality processes with an EQMS, organizations can ensure visibility, consistency and efficiency as well as compliance.
Related to - and just as complex as - quality management is document management, the process by which an organization’s mission-critical documents are developed, disseminated, updated, and archived in a controlled manner. FDA regulations, GMP, ISO requirements, and other governing regulations and standards have numerous requirements that address exactly how documents must be managed.
For example, suppose the master batch record for a drug manufacturing process must be changed due to a CAPA. This means the organization must not only execute all the needed technical drug manufacturing process changes (tracked with an EQMS), but it must do so while fully addressing all the associated documentation factors.
By leveraging a Document Management System (DMS), an organization can manage all aspects of creating, revising, and maintaining documents faster and easier than more manual processes. In addition, overall document security is greatly enhanced, as is document version tracking and control.
The EQMS and the DMS, although different solutions, both powerfully contribute to an organization’s overarching quality management policy. The EQMS does this by monitoring processes and quality events. The DMS does this by managing and monitoring documents. However, unless the two solutions are integrated, an organization’s productivity can suffer from lack of visibility across the interrelated quality and document management processes.
Organizations with highly functioning quality programs integrate quality management and document control processes, creating interconnections that generate synergy. Integrated best-in-class EQMS and DMS solutions allow organizations to realize maximum benefit by using purpose-built applications in concert to create transparency and increase the effectiveness of their quality management policies.
At Sparta Systems, we’re proud of our alliances with third-party integrators and best-of-breed enterprise document management system providers, supporting that synergy between quality management and document management. Through proven integration with solutions from QualityConnect certified partners, quality professionals are able to search and link documents stored in a document management system to records in TrackWise EQMS.
Learn more about these proven integrations and synergies with EQMS and DMS in this recorded webcast: “Optimizing the Relationship between Document Management & Quality Management” with QualityConnect partners, Impact Systems and EMC Documentum.
For more information regarding EQMS and DMS, download our whitepaper.