Document Control

SimplerQMS Document Control is a cloud-based module within an all-in-one electronic Quality Management System (eQMS) designed for life science companies. It centralizes document storage and management with version control, electronic signatures, and audit trails, supporting compliance with regulatory requirements including ISO 13485:2016, 21 CFR Part 820, 21 CFR Part 11, EU MDR, IVDR, EU GMP Annex 11, ISO 9001:2015, and GxP standards. The module is intended for quality professionals in medical device, pharmaceutical, biotech, laboratory, CRO, and CMO organizations.

The Document Control module is part of a broader eQMS platform that also includes training management, change management, deviation management, CAPA management, complaint management, audit management, risk management, equipment management, supplier management, and electronic batch records. The system runs on Amazon Web Services (AWS) and is validated according to GAMP5, with monthly re-validation cycles. It holds ISO 27001:2022 certification for information security.

Core Document Control Features

• Centralized, cloud-based document storage accessible from any device, including mobile
• Version control to track document history and changes over time
• Time-stamped audit trails for all document activity
• Electronic signatures compliant with 21 CFR Part 11 and EU GMP Annex 11, usable from any location
• Metadata-driven technology that automatically sets file names, versions, and relationships
• AI-generated change summaries to support faster review and approval
• Document linking to connect related documents, departments, and specific standard chapters (e.g., ISO chapters) in a single step
• Built-in document templates for standard procedures, complaints, change requests, CAPA, risk management plans, and more
• Support for creating and customizing additional templates

Access Control and Permissions

• Hierarchical access controls allowing administrators to restrict document visibility to specific employees, departments, sites, or projects
• Configurable access levels by document type, including SOPs, Meeting Minutes, and Work Instructions
• Ability to designate specific individuals as authors, reviewers, or approvers for each document
• Option to assign a named approver for documents such as CAPAs or SOPs, ensuring only that person can release the document
• Department-level read access can be granted once a document is released

Review and Approval Workflow

• Configurable workflows for document review and approval processes
• Automated email notifications to keep team members informed of tasks and assignments
• Workflow tools designed to reduce delays and prevent documents from being overlooked

Microsoft Office Integration

• Integration with Microsoft Word, Excel, and PowerPoint, allowing users to author and edit documents within familiar applications
• Document templates support streamlined creation and consistent organization
• Metadata-driven file management reduces manual naming and versioning steps

Audit Readiness and Traceability

• Document relationships enable quick retrieval of all documents linked to a specific requirement during audits
• Full document history with time-stamped audit trails is available at all times
• Cross-functional visibility supports traceability back to the root cause of nonconformances
• Documentation accessible from anywhere, supporting remote audit presentations

Implementation and Pricing

• Typical implementation time is 5 to 6 weeks, depending on document volume and available resources
• Pricing is based on the number of user licenses; the license includes QMS modules, implementation, user training, and ongoing support

SimplerQMS is developed by a team with over 30 years of life science industry experience. The platform is fully validated per GAMP5 and compliant with ISO 13485:2016, 21 CFR Part 820, 21 CFR Part 11, and EU GMP Annex 11 with respect to validation and electronic signatures. Users retain responsibility for ensuring the content of their documents meets applicable regulatory requirements.