OpenText™ Documentum™ for Quality & Manufacturing (Q&M) solutions are widely used in Life Sciences companies 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.
In order to ensure compliance, it is vital that users are trained on these documents and that training evidence is recorded as these trainings are audited and can be reviewed by regulators as and when needed. To address the training needs on these documents, Life Sciences organizations typically use a Learning Management System (LMS) which enables users to access trainings based on their job profiles. This requires an integration between Q&M and LMS systems as the GxP documents are residing in Q&M while the trainings for these documents need to be created and completed in LMS.
Integration based on status of documents
To begin with, the integration needs to factor in the status of the document in Q&M, whether it’s a New document, a Revised document or a Withdrawn or Suspended document.
Below are three possible integration scenarios. These could vary depending on organization specific needs.
For New documents
- Once the draft document has gone through a ‘Review and Approval’ workflow (or Approval Workflow) and reached the ‘Release Pending’ status, the integration could create learning items in LMS for this document.
- The document in Q&M would become ‘Effective’ after a specified time. Alternatively, the document can be made Effective when users complete the training in LMS. This could be based on the training being completed by all assigned users, or a certain predefined percentage of assigned users. In such a scenario, a communication can be sent back to Q&M to make the document Effective.
For Revised documents
- Once the revised document reaches Release Pending status, training for the revised document is initiated in LMS.
- The document in Q&M becomes Effective after completion of a specified training period. Alternatively, the document can be made Effective when users complete the training in LMS. This could be based on training completion by all assigned users or a certain predefined percentage of assigned users.
- The previous version of the document becomes superseded. Trainings for the superseded version would be deactivated in LMS.
For Withdrawn and Suspended documents
- Once a document is withdrawn in Q&M, all trainings for this document will need to be deactivated in LMS.
- Once a document is suspended in Q&M, trainings for this document will need to be temporarily deactivated in LMS. If in future the document is restored again, trainings can be activated.
Managing training materials in Q&M
Types of training material can include videos, quizzes etc. There may be a need to have these training materials go through an approval process before they are made available to users in LMS for training.
As Q&M solution has full document management and workflow capabilities, it can be used to store and manage these training materials. The training material can be uploaded to Q&M and be run through a review and approval process. Once Approved they can be pushed to LMS for Learning Items creation.
Life Sciences companies need to demonstrate to regulatory authorities that they are in complete control of their GxP documents and user trainings on those documents. A well-integrated OpenText Documentum for Quality & Manufacturing solution with a Learning Management System helps ensure compliance through effective training distribution and auditing & reporting of training outcomes.
Author: Anshul Kayastha – Anshul is a Life sciences Practice Lead at OpenText CoE who is passionate about technology, information management, architecture, integrations, and collaboration. Anshul has 18+ years of Documentum experience with extensive experience in Life sciences and BFSI domains focusing on helping customers implement large scale enterprise solutions