Automating Document Control in 2025: Don't Get Left Behind
February 20, 2025
Remember when fax machines were considered cutting-edge business equipment? Now it’s pretty hard to find a fax machine in modern office environments. Businesses moved to easier, more efficient ways to share information, brought about by a host of digital innovations.
Digital transformation continues to touch every aspect of industry and manufacturing. Our digital quality management efforts must keep up, especially document control, an essential element of compliance for regulated industries.
Word processing documents, spreadsheets and file folders, once the best solution for document control, are being replaced by full-suite software solutions that integrate document control with the processes it touches, such as product design, corrective actions, change control, auditing and even supplier management.
Remaining competitive in 2025, and beyond, means embracing the push to automate. Below we outline the benefits of abandoning clunky document management processes, such as spreadsheets and log books, and implementing dedicated document control software for faster, easier document management, regulatory compliance and market realization.
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 automated document control?
Automating document control involves implementing software that provides a single electronic solution for organizing, revising, routing for review, collecting required approval signatures, distributing and storing important documents. Automating document control creates efficiencies by automatically triggering necessary next steps throughout a document’s lifecycle, incorporating compliance efficiencies, such as traceability and electronic signatures, and being available anytime, from anywhere.
Why automate document control?
Document control is a key component of government regulatory compliance as well as industry standards, including U.S. Food and Drug Administration (FDA) 21 CFR requirements and International Organization for Standardization (ISO) standards, such as ISO 9001 and ISO 13485.
Despite the important role of document control, documentation insufficiencies remain the number one area of audit findings in both the ISO and FDA arenas. Unresolved audit findings delay the path to market realization and can pose significant costs to your company.
Maintaining documents manually, with disparate software solutions, is not only labor intensive, it is also inherently prone to errors, inefficiencies and disorganization.
A dedicated document control system provides a framework for compliance, offering features that ensure proper handling, including version controls, automated review routings and FDA-compliant electronic signature approvals. Beyond efficiencies, automated document control can help address shortages in available skilled labor and free up resources to be used on more impactful business operations.
Features of an automated document control system
A robust document control system will automate every aspect of a document’s lifecycle, ensuring compliance mandates are addressed. Key automations include:
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Document Creation
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Document Identification
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Review and Approval – routing and FDA-accepted electronic sign-offs
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Version Control – tracking document revisions and archiving or deleting outdated versions
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Access Controls – restricting document access to authorized personnel, defining who can view, edit, approve and distribute documents
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Storage and Archiving - defining systems and locations for storing and archiving documentation
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Management of Third-Party Documentation
How to do document control in 2025
With modern technologies, such as Quality Management System (QMS) software, document control is completely automated and connected, reducing the opportunity for human error and keeping quality tasks on track so users know where to find important documentation when it’s needed.
QMS software is geared toward regulatory compliance, making necessary compliance tasks a part of everyday processes. Below are a few of the features built into QT9’s QMS software that make automated document control superior:
Paperless Approval Routings with Electronic Signatures
Document control software easily routes documents to the appropriate individuals for approvals and allows for FDA 21 CFR Part 11-compliant electronic signatures. Approval routings stay on track using email alerts and visual to-do lists, letting you process compliance items faster and more accurately.
Online Collaboration
With QMS software, it’s easy to get feedback on documentation changes before approval submission. Documents are centrally located in the QMS, and reviewers can access documents from any location. Automated messaging reminds users of review tasks and provides management with insight into review status.
Visual Document Relationships
Document control software users are able to establish a system of document hierarchies, with parent or child relationships that are easy to identify if impacted by document revisions.
Automatic Training Links
Once document changes have been made and approved, QMS software can be configured to automatically trigger employee training, so training is initiated with the correct individuals and automatically documented for audit purposes.
Links to Quality Functions
Using document control as part of QMS software allows you to link documents to other critical quality processes such as:
This eliminates the need for disparate systems, providing continuity and organizational efficiency.
Links to Operational Functions
In addition, documents can be easily linked via operational function, such as:
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Shop Floor Manager
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Master Batch Record (MBR)
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Device Master Record (DMR)
Improved Accessibility
Important documents are more accessible with a web-based central management system. Users are able to access documents from their computer, phone or tablet.
Supplier Participation in Document Control
Whether it is sharing controlled documents with your suppliers or having customers sign off on spec changes, web portals make this easy.
Choosing a document control system
Choosing the best document control system for your organization should involve an evaluation of your company’s needs against the software’s core features, such as storage and retrieval, version control and accessibility. Test the software through a demo or free trial to evaluate its suitability for your business before making a commitment.
Other factors to consider include:
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Ease of Use – Look for a system that is easy to use and navigate in order to support user adoption. Consider how quickly employees can be trained to use the system efficiently.
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Compliance Compatibility – Ensure the system supports compliance with relevant standards, such as ISO, FDA and ICH Q10.
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Security – Ensure the system has appropriate security features, such as encryption, two-factor authentication and other access controls
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Scalability – Consider whether the software can grow with your business. It should handle increasing document volumes and users without compromising performance.
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Cloud vs. On-Premise - Cloud-based software delivery offers flexibility, remote access and regular updates but depends on internet connectivity. On-premise software can provide greater control over data but may require significant upfront investment and ongoing maintenance.
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Customization Capabilities - The software should enable necessary customization or configurability to fit your business’ specific workflows, naming conventions or document lifecycle requirements.
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Costs – Be sure to evaluate the total cost of your software investment, including licensing, implementation, training and support fees.
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Customer Support - Look for providers that provide robust customer support and training options with and quick response times.
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Implementation Timeline - Assess the time required for deployment, data migration and employee training, ensuring minimal disruption to operations.
QT9 QMS for simplified document control
QT9 QMS document control software is a highly rated, affordable, easy-to-use quality management system that excels at document management, with robust features that include:
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Configurable workflows
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Version control with built-in audit trail
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Secure file sharing and access controls
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FDA 21 CFR Part 11-compliant electronic signature capability
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Cloud-based collaboration and accessibility
QT9 QMS has 25+ modules that come standard, including document control, risk management, corrective actions, employee training and supplier management - all of the processes that go into providing high-quality goods and services that are FDA and ISO compliant. QT9 QMS also offers unlimited scalability and traceability.