Quality Management

Document & Records Management

Document & Records Management software provides controlled authoring, review, approval, versioning, distribution and retention of regulated documents and records, primarily for quality and EHS functions. It supports structured workflows for creating and revising SOPs, work instructions, specifications and other controlled documents, enforcing electronic signatures, audit trails, access controls and defined retention/disposition schedules. Systems typically integrate with broader quality management processes (CAPA, change control, training) to ensure the right version is in use, approvals are documented, and historical versions are preserved for inspection. This differentiates it from general-purpose content or file-sharing systems lacking formal compliance controls, targeting regulated industries such as life sciences, manufacturing and healthcare operating under standards like 21 CFR Part 11 and ISO 9001.

It addresses the risks of uncontrolled document sprawl across shared drives and email—wrong versions being used, unclear approval status, and inability to prove who changed what and when. It solves compliance exposure under regulations such as 21 CFR Part 11 and ISO 9001 by enforcing audit trails, electronic signatures and retention schedules, reducing the risk of failed inspections or audits. It eliminates manual, error-prone tracking of document lifecycles, speeds review/approval cycles, and ensures staff always work from the current authorized version. It also mitigates data integrity and traceability gaps between quality events, training records and document revisions, and reduces the burden of retrieving historical document states during audits or legal discovery.

Key capabilities

Document Management
Approval Workflows
Audit Trails
Compliance Management
Role-Based Access Control
Change Management
Quality Management

Common use cases

Document and Drawing Control
Compliance Management
Audit and Inspection Management
Corrective and Preventive Action (CAPA) Execution
Quality Management

Who it's for

Quality Manager
EHS Manager
Regulatory Affairs Manager

Common integrations

Quality Management Systems (QMS)
Document Management Systems
Learning Management System (LMS)
EHS Management Software
Audit Management Platforms

Evaluating Document & Records Management?

Katia Makshanova leads Verdantix research in this category. Speak to them for independent guidance on current coverage and the right shortlist for your requirements.

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