by Lori McKellar, EMC
Organizations in the highly regulated life sciences industry face continual pressure to maintain the highest level of quality control in every facet of their operations. By its very nature, quality management in pharmaceutical manufacturing is complex, and with the great number of processes, controls and specifications involved, it is critical that companies strictly adhere to standard operating procedures to ensure compliance with good manufacturing practices (GMP).
Of course, at the same time, these businesses are being tasked with reducing costs and preserving profitability. Add to these demands the additional complexity of numerous suppliers and contract manufacturing partners involved in the process, and the need for an Enterprise Quality Management System (EQMS) that defines, tracks, manages and reports all critical quality and compliance processes becomes quite evident.
Enterprise Content Management (ECM) is an organization’s definitive system of record for all controlled documentation regulating functions including how documents are created, reviewed, approved, trained on, distributed for use, revised and retired. Since governing regulations and standards from the FDA, EMA, GMP, ISO and others have vast requirements that address exactly how documents must be maintained, a critical part of quality management is the administration of all documentation related to these processes.
However, with quality control and manufacturing processes constantly changing and being updated to maximize safety and efficiency, it is vital that these changes are also reflected in related documentation throughout a drug’s lifecycle. As an example: It is determined that an element of a drug manufacturing process must be changed due to a Corrective Action Preventative Action (CAPA). As a result, organizations must not only execute all needed technical drug manufacturing process changes, tracked with an EQMS, but must do so while fully addressing all required changes in the associated, controlled documents, which could include things like standard operating procedures, validation documents, master batch records, work instructions, specifications, methods, etc.
Transforming Quality Management Through Integration
EQMS and ECM systems focus on different aspects of the quality and manufacturing processes. The EQMS monitors processes and quality events while the ECM system manages the associated documentation. However, both powerfully contribute to an organization’s overarching quality management policy and unless the two solutions are integrated, an organization’s productivity can suffer from a lack of visibility across the interrelated quality and document management processes. Combining these systems transforms the process to add value to the output of both systems while generating synergy between them. Each system reinforces and enhances the other, thereby assuring the organization of improved performance, compliance, visibility and risk avoidance.
By integrating the EQMS system with the ECM system, organizations can maximize efficiency and enforce adherence to GMP requirements. Users of the EQMS system can remain in their day-to-day application and yet easily search and find all relevant documents related to a quality event. These documents can then automatically be linked to a quality record as supporting references or information related to the event. Documents can also be linked to the quality record as impacted documents, indicating that changes on the specified documents are required as a result of the event. In this latter case, an integration between the EQMS and the ECM system will notify the owners of the impacted documents of the required changes. As the documents are created, revised or obsoleted in the ECM, individual status changes on each document will be reflected and visible to the user in the EQMS. Business rules can be defined in the integration that can include automatic user notifications and processing or progression of the quality record in the EQMS once all of the documentation updates are completed in the ECM.
Effective quality management requires the detailed recording, tracking and addressing of quality events in an EQMS in conjunction with the controlled accessibility, creation, revision and obsoletion of critical documentation in an ECM. By enabling information to seamlessly move between the systems at the appropriate time on an as-needed basis, the end result is a complete and comprehensive quality solution with a decreased risk of non-compliance and increased visibility, traceability and process efficiency across the organization.
A Real Life Scenario — Bacteria Levels Exceed Defined Limits
As an example, a lab inspection at a pharmaceutical or medical device manufacturer may yield a finding that bacterial levels are exceeding defined limits. Let’s walk through the process and highlight the flow of information between the two systems.
First, the deviation is found and an investigation ensues. In this case, the result of the investigation indicates that a cleaning agent being used is insufficient to keep bacteria levels within limits. A CAPA is triggered in the EQM system to identify a new vendor that can supply a satisfactory cleaning agent. Once this vendor has been identified, a change control process takes place that identifies all associated documents, both standard operating procedures (SOPs) and work instructions that reside in the ECM system. New versions of these documents must be created indicating the vendor change and revised usage instructions. These documents then go through the required review and approval process in the ECM system. Once the revisions are complete, the documents’ status in the EQMS system is updated to indicate they are pending implementation. When the alteration is complete, the Change Control quality record is closed and the revised documents become effective.
Tangible Business Impact and Return on Investment
One large pharmaceutical company improved approval times, reduced exception turnaround times and reduced batch records corrections by integrating their EQMS and ECM systems.
In the first year after implementation, they experienced:
46 percent reduction in approval times for executed validation packages
20 percent reduction in average turnaround time for deviations
79 percent reduction in production batch record turnaround time
68 percent reduction of batch record corrections
The positive business impact continued into the second year where they saw:
34 percent additional reduction in average turnaround time for deviations
50 percent additional reduction in production batch record turnaround time
58 percent additional reduction of batch record corrections
The company’s system analyst said a huge benefit of the integration is “… the ability to have real-time visibility into the end-to-end quality process and associated content, which enables prompt action if needed.”
All organizations have varying degrees of automation and integration when it comes to Life Sciences manufacturing. These variations can be thought of as a maturity model of sorts. Some organizations may be using paper-based systems and manual processes, or multiple, disconnected point solutions. Others may have global processes but still utilize multiple, disconnected quality or ECM systems, or have global processes and identified EQMS and ECM systems of record. However, those at the top of the maturity model, where business value and quality excellence are maximized, combine global quality processes that integrate with other critical systems. These combinations, such as an ECM solution and a Quality Management application, ensure seamless workflows and information sharing across the end-to-end quality process. Regardless of where a company is on this continuum, efficiencies can be gained by harmonizing processes, unifying key systems and ensuring seamless workflows that automate the full business process.
Lori McKellar is global director of Life Sciences Marketing for EMC’s Enterprise Content Division.
This article originally appeared in the March 2016 issue of Workflow.