Document Control

Document control software streamlines the management of documents within the life sciences sector, ensuring that all files are audit-ready and accurately maintained. By integrating into an all-in-one cloud-based quality management system (eQMS), it helps organizations achieve regulatory compliance and improve documentation workflows.

The platform allows seamless work within Microsoft Office, letting users create and manage documents using familiar tools like Word, Excel, and PowerPoint, and employs metadata-driven processes for automatic setting of file relations, naming, and versioning.

Key Benefits and Features

• Stores documents securely in a cloud-based system compliant with ISO 27001:2022 and FDA 21 CFR Part 11, ensuring data is safe and accessible from anywhere.
• Supports compliance with various standards, including GxP, ISO 13485:2016, 21 CFR Part 820, ISO 9001:2015, EU MDR, and IVDR.
• Offers pre-validated templates to minimize errors and facilitate accurate documentation creation.
• Provides document access controls, allowing restrictions based on department, project, or document type, with specific roles for authors, reviewers, and approvers.
• Streamlines review and approval processes with workflows and email notifications, reducing delays in document releases.
• Facilitates quick retrieval and association of documents with specific requirements, aiding audits.

This software is designed to simplify the document management process by reducing the risks of misplaced or incomplete documents and integrates flawlessly with existing Microsoft Office applications, enhancing user experience by keeping workflows smooth and efficient.