What is a controlled document?

A controlled document specifies instructions or procedures necessary to ensure the quality and consistency of a product or service. Controlled documents require formal review, approval and controlled distribution, access and storage. Examples include onboarding materials, certifications, performance evaluations, corrective actions and surveys.

What is document control software?

Document control software automates and centralizes the management of document creation, approvals, revisions, distribution and storage. It streamlines compliance through audit trails, traceability and electronic signatures and offers accessibility from anywhere.

How does document control software work?

Document control software is typically cloud-based, making documents accessible anytime from anywhere via the internet. On-premise solutions are also available, storing data on a local server managed internally.

What are the benefits of document control software?

Benefits include a central repository, automated audit trails, risk management, improved onboarding and training, access control, and built-in efficiencies like automatic archiving, alerts, electronic approvals and real-time data access.

Why should I use QT9 QMS for my document control?

QT9 QMS is an affordable, highly rated quality management system that includes 25+ modules like document control, risk management and employee training. It offers scalability, traceability and helps meet FDA and ISO compliance requirements.

Is QT9 QMS compliant with FDA 21 CFR Part 11?

Yes, QT9 QMS supports electronic signatures and audit trails to fully comply with FDA 21 CFR Part 11.

Can QT9 be used for ISO 9001 document control?

Yes, QT9 helps meet ISO 9001 requirements for document control by automating approvals, version control and employee training acknowledgment.

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