Connected Document Management Across the Quality Lifecycle
OneQMS Document Management Software provides a secure, cloud-based Document Management System (DMS) for creating, reviewing, approving, distributing, revising, and retiring controlled documents. Designed for pharmaceutical, biotechnology, CRO, CDMO, medical device, and other regulated organizations, OneQMS centralizes SOPs, work instructions, policies, specifications, forms, templates, and other quality documents, ensuring users can access the correct approved version when needed.
Each Document follows a controlled lifecycle from creation and review through approval, effective release, periodic review, revision, archival, and retirement. Automated version control maintains revision history and helps prevent obsolete documents from being used, while configurable workflows, electronic signatures, and role-based permissions ensure documents are reviewed, approved, and made available according to defined requirements.
OneQMS connects Documents with related Training, CAPAs, Change Controls, Deviations, Audit Findings, Customer Complaints, OOS, OOT, Quality Issues, and Incidents, allowing teams to understand how document changes affect connected quality processes. Automated training assignments, review reminders, notifications, and document workflows help organizations maintain control when procedures and other controlled content are updated.
Built for organizations operating under GMP, GxP, FDA 21 CFR Part 11, and EU Annex 11 requirements, OneQMS provides electronic signatures, role-based access controls, document history, audit trails, controlled approvals, and review schedules to support data integrity, regulatory compliance, and inspection readiness.
Whether you are looking for Document Management Software, Document Control Software, Electronic Document Management System (EDMS), SOP Management Software, Pharmaceutical Document Management Software, Quality Document Management Software, or an integrated eQMS, OneQMS provides a secure, scalable platform that strengthens document control, simplifies document workflows, improves accessibility, and maintains complete traceability throughout the document lifecycle.
Key Capabilities
Centralized Document Control
Maintain controlled documents within a single repository, giving employees a reliable location to access approved SOPs, procedures, policies, specifications, forms, and work instructions.
Controlled Document Lifecycle
Manage each document through defined stages including creation, review, approval, release, periodic review, revision, archival, and retirement, providing visibility throughout its lifecycle.
Version and Revision Control
Track document revisions and maintain historical versions so teams can distinguish current approved content from previous or obsolete versions and preserve the document's complete history.
Review and Approval Management
Automate document routing to designated reviewers and approvers, with configurable workflows and electronic signatures helping ensure controlled content is formally reviewed before release.
Document-to-Training Connection
Link controlled documents with training requirements so that relevant training can be assigned when documents are introduced or revised, helping organizations maintain alignment between procedures and employee training.
Compliance & Inspection Readiness
Maintain document histories, electronic approvals, signatures, review records, permissions, and audit trails to support GMP, GxP, FDA 21 CFR Part 11, and EU Annex 11 requirements and provide controlled documentation during audits and regulatory inspections.
Key Features
Document Lifecycle Management
Manage documents from creation and review through approval, release, periodic review, revision, archival, and retirement.
Centralized Document Repository
Store SOPs, policies, specifications, forms, templates, work instructions, and other controlled documents in one searchable location.
Automated Version Control
Maintain revision history and ensure users can identify the current approved version of each document.
Configurable Review and Approval Workflows
Route documents to the appropriate reviewers and approvers based on organizational requirements.
Electronic Signatures
Support controlled electronic approvals and signatures in accordance with applicable regulatory requirements.
Role-Based Access Control
Manage document visibility, access, permissions, and responsibilities according to user roles.
Periodic Review Management
Schedule document reviews and automatically notify responsible users when reviews are due.
Document-Triggered Training
Assign required training when controlled documents are newly released or revised.
Powerful Search and Retrieval
Quickly locate controlled documents and relevant document information through centralized search.
Complete Audit Trail
Maintain a detailed history of document activities, revisions, reviews, approvals, and access-related actions.