Since its launch, eQCM has been driving better outcomes for organizations in regulated industries. Pharmaceutical, biotech, and medical device companies and CROs rely on eQCM to ensure they maintain compliance. As regulators continue to inspect quality management systems in increasing detail, eQCM gives organizations a single, connected platform to manage all of these processes rather than relying on disconnected spreadsheets, paper records, or standalone tools.
As the regulatory environment evolves and the pressures faced by life sciences organizations shift, the systems used to ensure compliance must also adapt. That’s why Instem continuously develops and updates eQCM. Version 10 represented a significant step in that development, updating the underlying technology, redesigning the end-user interface, and adding an out-of-the-box QMS workflow. eQCM 10.0.1 builds on that foundation with a focused set of enhancements designed to tighten control around document management and audit trails.
Controlled Printing and Downloads
Uncontrolled printing represents a persistent document control gap in regulated environments. Outdated printed copies that continue to be used after a document has been revised, or printed documents whose source cannot be established during an inspection, are common findings.
To combat this, eQCM 10.01 introduces greater printing controls. Users with printing authority can still print, but the act of printing is now captured in a log that is visible from the document’s history. Each document that has been printed is therefore traceable in the same way that other document interactions are recorded in the audit trail. Documents in eQCM can now be viewed directly in a browser by both admin and end-users without the ability to print or download. This means that the default mode of document access is read-only.
Training-Controlled DMS Access
eQCM’s document management system (DMS) acts as a central organizing platform for controlled documents like SOPs, work instructions, and policies. However, some of these documents can require specific training before they can be properly and safely acted upon.
Version 10.0.1 introduces the ability to require that readers complete training before they are permitted to view the latest version of a document in the DMS. Until training is completed, access to the current version is restricted. This system actively enforces the link between training and document access rather than relying on manual oversight or the assumption that staff will complete training.
Locked Audit Trail
FDA 21 CFR Part 11 requires that audit trails be computer-generated, time-stamped, and secure. However, the ability to disable an audit trail on a module after it has been enabled threatens the requirement for security. In version 10.0.1, once an audit trail is enabled on a module in Solution Builder, it can no longer be disabled by an administrator. This removes the possibility of an audit trail being switched off after it has been established, whether through error, pressure, or intent. This ensures that the record of activity within a module is permanent and complete from the point of activation.
PDF Converter Enhancement
PDF conversion capabilities introduced in version 10 included integrated conversion of text, Word, Excel, PowerPoint, and HTML. eQCM 10.0.1 builds on this with the ability to include page numbers and total page count in document headers and footers. For controlled documents, page numbering and organization (pagination) are important beyond presentation and readability and play a role in compliance. A document with clear page numbering and total page count makes it possible to detect immediately whether pages have been removed, substituted, or are missing. This is particularly relevant for documents used in regulatory submissions, inspection packs, and audit responses.
Conclusion
The enhancements in eQCM version 10.0.1 reflect the principle that a quality management platform in a regulated environment must evolve continuously. This is not only to add functionality, but also to respond to the changing expectations of users and regulators. Document control and audit trail integrity represent areas that can expose organizations to significant risk if not handled with care and expertise. The enhancements introduced in eQCM 10.0.1 address some potential pitfalls in these areas by embedding tighter controls into the system architecture
Request a demo today to find out more about eQCM 10.0.1 and how it can strengthen your organization’s document control and quality management processes.
