Compliance and Control: Essential EDMS Features Explained

Choosing the Right Electronic Document Management System: Prioritizing Controlled Issuance and Retrieval

In the life sciences industry, the demand for efficient and compliant Electronic Document Management Systems (EDMS) is ever-increasing. Most EDMS solutions available in the market today emphasize features like workflow management, attractive user interfaces, data-rich dashboards, and nice-to-have functionalities such as annotations. While these features are undoubtedly appealing and useful, they often divert attention from a critical area: the controlled issuance and retrieval of documents.

The Overlooked Pitfall

Recently, an USFDA observation shed light on a serious oversight within an organization’s EDMS. Despite having an EDMS to enhance document control and management, the system failed to prevent the issuance of duplicate documents, leading to discrepancies in production data. This issue raises several pertinent questions:

1. Is the system inherently flawed, allowing duplicate copies to be issued?
2. Was the reprint functionality misused due to inadequate user training or system controls?
3. Were privileges misassigned or abused, allowing unauthorized document reprints?

The Real Concern

While the allure of a sleek interface and advanced features is strong, the primary concern for pharmaceutical companies should be the controlled issuance and retrieval of documents. Effective document control is not just about managing workflows or tracking revisions; it’s about ensuring that every issued document is authentic, authorized, and retrievable in its correct form.

Key Features to Look For

When selecting an EDMS, it is crucial to focus on features that ensure robust document control, such as:

1. Approval Workflow for Reprints: Ensure that the EDMS has a stringent approval process for document reprints. This feature should restrict reprinting capabilities to authorized personnel only, preventing unauthorized duplications.
2. Differentiated Privileges: Look for systems that allow differentiated privileges for printing and reprinting. Production personnel should have printing capabilities, but reprints should require approval from quality assurance or other authorized personnel.
3. Dynamic Print Attributes: An effective EDMS should manage print attributes dynamically, adding specific information to reprinted documents while printing to ensure traceability and authenticity.

The Importance of Controlled Printing

Controlled printing is not just a regulatory requirement; it’s a cornerstone of data integrity. In the case mentioned, the failure to control document reprints led to discrepancies that could have serious compliance implications. Therefore, when selecting an EDMS, prioritize solutions that offer robust controls over document issuance and retrieval.

Conclusion

In the fast-paced world of pharmaceutical digitization, it's easy to be swayed by eye-catching features and user-friendly interfaces. However, the true value of an EDMS lies in its ability to maintain the integrity and traceability of documents. As you navigate the selection process, focus on systems that emphasize controlled issuance and retrieval. By doing so, you will not only ensure compliance but also enhance the overall reliability and effectiveness of your document management processes.

If you are ready to explore EDMS solutions that prioritize what truly matters—controlled document issuance and retrieval—let's connect and find the best fit for your needs. Your commitment to data integrity and compliance begins with the right choice of technology.