Quality is at the heart of the highly regulated Life Sciences industry. Ever changing regulations and technology are improving the quality of people’s lives, although often at the cost of increased complexity in managing business processes.
In this blog we will discuss the value of the integration of a Quality Management System (QMS) with OpenText™ Documentum™ for Quality & Manufacturing (Documentum for Q&M) and how to approach this integration. The integration is important as it gives users a cohesive experience where they can manage processes and related documents and make systems adaptable to their needs based on their role within the organization. This also helps ensure that business needs and compliance requirements are addressed in conformance with regulatory requirements.
Documentum for Q&M is widely used in Life Sciences organizations to create, maintain, and revise quality and manufacturing documents. These quality and manufacturing documents are GxP documents that consist of Standard Operating Procedures (SOPs) and other controlled documents.
A Document Change Request (CR) in Documentum for Q&M is used to describe a proposed change to Category 1 documents (such as SOP’s, specifications, instructions, batch records or methods). It helps pharmaceutical manufacturers to comply with GMP and ICH Q10 guidelines by enabling them to maintain a record of changes made to documents. This demonstrates control over GMP documentation while conforming to GMP standards.
Authors or document coordinators can initiate CRs to create Category 1 documents, or to propose changes to existing Category 1 documents, or suspend or withdraw documents. These CRs enable tracking of document revisions and provides a link between the document version and related change control.
Several large pharmaceutical companies have QMS (such as TrackWise, MasterControl QMS etc.) for global management and harmonization of quality systems. This includes Change Controls (change management system), deviations (deviations and quality events), complaints, investigations, risk management, CAPA etc.
A Change Control is much wider in scope than a Document Change Request as it includes Change Request as one of its elements. While a CR is limited to controlled content changes only, a change control can include non-content related changes as well.
Since the change process is driven by the QMS system, integrating it with a document management system such as Documentum for Q&M, that hosts all controlled documents can become vital to ensure direct visibility to impacted documents.
How to approach an integration
A pharmaceutical company can have the QMS drive Change Control which means that Change Control is created in QMS. Post review and approval of the Change Control, details such as Change Control Record number and Approval Date can be synced with Documentum for Q&M. This would be necessary to initiate a review and approval (or withdrawal) of the document in Documentum for Q&M.
The Change Control initiated in QMS may impact certain Effective documents in Documentum for Q&M (Fig1: Integration for Effective documents). The integration needs to provide the ability to identify such Effective documents and associate them with the Change Control. When a document becomes Release Pending/Effective or Withdrawn, a notification can be triggered to QMS (with document version and status) to close the Change Control Record in QMS.
There could also be draft documents that are part of the Change Control (Fig2: Integration for Draft documents). Once the Change Control is approved, the linked documents in Documentum for Q&M can move ahead in the review approval process and be made Effective.
The Change Control could involve Effective documents that could be either Withdrawn or Suspended (Fig3: Integration to Withdraw/Suspend documents) as part of the Change Control process. Such documents can be linked to the Change Control and once the Change Control is approved, they can be Withdrawn/Suspended.
As the Change Control is now driven by QMS, the Change Request feature in Documentum for Q&M can be disabled to solely rely on the external QMS. This feature can also be made optional as there could be some parts of the organization that may still use the Documentum for Q&M Change Request functionality.
What are the real benefits to be achieved from an integration?
Life Sciences companies face several challenges in managing quality processes and quality documentation together, especially around Change Control. Change Control often leads to document updates therefore effective document control is a critical component in the Change Control process. If these two systems are disconnected it can increase compliance risks due to a lack of visibility and a degraded audit trail. For instance, it could become challenging to find documents that are affected by Change Control. Similarly, finding out if a particular document is under Change Control could also become cumbersome resulting in a poor user experience.
As there are increased expectations from regulatory authorities around transparency, a seamless integration between these two systems can provide effective end-to-end visibility that not only helps optimize performance, but also provides effective traceability, auditing and reporting. In addition, maintaining only one system for all Change Controls instead of two is far less cumbersome for organizations to maintain.
The OpenText™ Professional Services team has years of experience working with customers on their Life Sciences implementations. Contact us for more information.
Author: Anshul Kayastha is a Life Sciences Practice Lead at OpenText™ Centre of Excellence (CoE) who is passionate about technology, information management, architecture, integrations, and collaboration. Anshul has been working with Documentum for over 20 years with extensive experience in Life Sciences and BFSI domains focusing on helping customers implement large scale enterprise solutions.
