Document Control Software for Quality and Compliance
Simplify version control, streamline approvals and eliminate manual documentation processes — all in one secure QMS platform.
Automated Versioning
Always access the latest approved document.
Real-Time Access
View and manage the latest files from any device.
Paperless Workflows
Ditch manual processes and paperwork.
E-Signatures & Audits
Sign and track documents with compliant workflows.
ISO & FDA Compliance
Built to meet strict regulatory standards.
Streamlined Approvals
Auto-assign reviewers with instant alerts.
What is document control software?
Document control, also called document management, is the process an organization uses to ensure that important documentation is created, approved, revised, distributed, tracked and stored systematically throughout its lifecycle. It is a main component of business and manufacturing quality standards (such as ISO 9001 and GMP), with the goal being to demonstrate consistency and accuracy in operations.
QT9’s document control software simplifies how companies manage quality documents. From SOPs and work instructions to policies and procedures, QT9 helps automate version control, approvals and employee acknowledgment tracking. Fully integrated within QT9 QMS, it helps maintain compliance with ISO, FDA and EU regulations and simplifies audit readiness.
Features that power seamless document control
Free up time with document control tools built in to QT9 QMS.
Version Control
Only the latest approved version is accessible—with full revision tracking and audit logs.
E-Signature Approvals
Email Alerts
Audit Reporting
Access Control
Training Triggers
Linked Documents
Master Copies
File Type Support
QT9 QMS vs. manual/SharePoint
Centralize data with 25+ modules
Document Control
Audit Management
Training Management
Risk Management
FAQ: Document Control
A controlled document is any form of documentation that specifies instructions or procedures necessary to ensure the quality and consistency of a product or service. Controlled documents are subject to formal review and approval as well as controlled modification, distribution, access and storage.
- Onboarding
- Documentation, including certifications
- Performance evaluations
- Corrective actions
- Surveys
Document control software automates the steps that make up a document management system, streamlining and centralizing document creation, approvals, revisions, distribution and storage. Document control software creates efficiencies by automatically triggering necessary steps throughout a document’s lifecycle, incorporating compliance efficiencies, such as traceability and electronic signatures, and being available anytime, from anywhere.
Document control software is typically cloud-based, meaning that it is stored, managed and available through the internet. Cloud-based document control software is accessible anytime, anywhere. Some companies offer an on-premise solution, where the software is installed and run on a local server and managed on site.
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Central Repository: Document control software serves as a central location for all of your documentation, making it easier to find and deliver documents.
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Audit Trail: Automated document control automatically creates an audit trail, allowing you to track the history of changes made to documents. This is especially helpful during the auditing process to demonstrate document control and quality control to regulators.
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Risk Management: Document control software provides a clear record of specifications, requirements and procedures, allowing you to proactively address potential issues and contributing to better control over business outcomes.
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Training and Onboarding: Having standardized and controlled documentation ensures that new employees receive accurate and consistent information, helping them integrate into their positions and contribute effectively.
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Access Control: Security measures can be easily established based on named criteria, such as user, location and document lifecycle. Only verified users with authenticated permission can be given access and the documents are secure, encrypted and protected within the application.
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Built-in Efficiencies: Document control software offers efficiencies such as automatically archiving obsolete documents; email alerts and reminders for changes, reviews and approvals; links to training; electronic approvals; and access to real-time data for better insight into your document control efforts.
QT9’s QMS software is a highly rated, affordable, easy-to-use quality management system that excels at, not only document management, but all of the processes that go into providing high-quality goods and services that are FDA and ISO compliant.
QT9 QMS has 25+ modules that come standard, including document control, risk management, corrective actions, employee training and supplier management. QT9 QMS also offers unlimited scalability and traceability.
Yes, QT9 QMS fully supports electronic signatures and audit trails to meet FDA 21 CFR Part 11 requirements.
Absolutely. QT9 helps you meet ISO 9001 requirements for document control by automating approvals, version control and employee training acknowledgment.
Document control resources
Automating Document Control in 2025: Don't Get Left Behind
Implementing Document Control Software
Medical Device Document Control
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