Frequently Asked Questions: Document Control
What is document control?
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.
What is a controlled document?
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.
What is document control software?
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.
How does document control software work?
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.
What are the benefits of document control software?
- Central Repository: Document control software serves as a central location for all of your documentation, making it easier to find and deliver documents.
- 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.
- 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.
- 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.
- 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.
- 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.
Why should I use QT9 QMS for my document control?
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.
