Implementing Document Control Software

June 25, 2024

Talk to any QT9 customer about moving their manual quality system to our eQMS, and you’ll inevitably hit upon how life-changing the document control module has been for them. If you work in a closely regulated industry, you can likely relate. Often, every step of operations must be documented, and documentation must be controlled, always current and accessible. Documentation compliance can easily become overwhelming and mistakes easily made, slowing operations and costing time and money.

For these and many other reasons, the benefits of implementing document control software far outweigh the temporary inconvenience of moving document management into an automated platform. In this article, we’ll explore the primary justifications for implementing document control software and how you can do so with the least interruption to your employees and operations.

What is document control software?

Document control software organizes the way documents are approved, revised, distributed and stored. 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 helps organizations maintain consistency, reduce errors and ensure compliance to industry standards and regulations.

How does document control software work?

Document control software is designed to manage, store and track documents in an organized manner, ensuring that they are easily accessible, secure and up-to-date. The underlying structure automates manual processes and enhances them with features such as automatic alerts if revisions, signatures or training are needed. Below is an overview of how document control software typically works:

Document Storage

Centralization: Users can centralize documents by adding files from virtually any file type into the system.

Version Control

Automatic Versioning: The software tracks changes made to documents, automatically creating new versions whenever edits are made.

Version History: Users can view the entire version history of a document, including who made changes and when. This ensures transparency and accountability.

Archiving: Once documents are obsolete, they are automatically archived by the system, so only the most current documents are used.

Access Control and Security

User Permissions: Document control software allows administrators to set permissions, controlling who can view, edit or delete documents. Permissions can be set at various levels, such as individual users, roles or groups.

Authorization: Documents can be protected so that access requires authentication to ensure that only authorized personnel can view or modify sensitive information.

Workflow Management

Approval Processes: The software can automate approval workflows, routing documents to the appropriate personnel for review and approval before they are finalized.

Notifications and Alerts: Users receive notifications when documents require their attention, such as pending approvals or upcoming review dates.

Training Triggers: Document changes that require additional training are automatically assigned and monitored via the software.

Audit Trails

Tracking and Logging: Every action taken on a document is logged, creating an audit trail that records who accessed, edited or approved the document and when.

Compliance Reporting: Logs can be used to generate reports for compliance purposes, demonstrating adherence to regulatory requirements and internal policies.

Document Retrieval

Indexing: Documents are indexed based on assigned attributes, such as titles, categories, keywords, or document number, making them easily found.

Retrieval: Users can retrieve documents using filters based on their criteria to quickly locate documents.

User Interface

Dashboard: A central dashboard provides an overview of document statuses, recent activities and pending tasks.

User-Friendly Design: Intuitive interfaces and user-friendly designs make it easy for users to navigate and use the software effectively.

Backup and Recovery

Automated Backups: Regular automated backups ensure that documents are not lost due to system failures or other issues.

Disaster Recovery: The software includes features for disaster recovery, allowing documents to be restored quickly in case of data loss.

Benefits of document control software

The benefits of using document control software are rooted in regulatory compliance, accuracy and efficiency. With it, companies greatly reduce the potential for operational obstacles that can become costly. Some of the major benefits of document control software include:

Paperless Approvals/Electronic Signatures: Document control software easily routes documents to the appropriate individuals for approvals using email alerts and visual to-do lists, as well as allowing for FDA 21 CFR Part 11-compliant electronic signatures. Approval routings stay on track, letting you process compliance items faster and more accurately.

Visual Document Relationships: Document control software users are able to establish document hierarchies, with parent or child relationships that are easy to identify, which is important when all are impacted by document revisions.

Central Repository: Document control software serves as a central location for all of your documentation, making it easier to find and deliver documents.

Automatic 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 your team to proactively address potential issues and contributing to better control over business outcomes.

Online Collaboration: With cloud-based document control software, it’s easy to get feedback on documentation changes before approval submission. Documents are centrally located and reviewers can access documents from any location. Automated messaging reminds users of review tasks and provides management with insight into review status.

Standardized 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.

Better Access Control: Security measures for document access can be established based on named criteria, such as user, location or document lifecycle. Only verified users with authenticated permission can be given access and the documents are secure and protected within the application.

Workflow Efficiencies: Document control software offers built-in efficiencies such as automatically archiving obsolete documents; email alerts and reminders for changes, reviews and approvals; links to training; and access to real-time data for better insight into your document control and quality efforts.

Implementing document control software

Transitioning to a new document control method can seem daunting, especially if your current method encompasses several different applications and/or manual methods. Good preparation, training and communication are key. Here are a few best practices for implementing new document control software:

Assess needs: Consider the types of documents you manage, the processes they go through and the regulatory requirements and deliverables you must meet.
Address needs: Armed with knowledge about your needs, research and select a document control software that aligns with your requirements. Be sure to consider user reviews, customer support and scalability.
Plan for implementation: Create a detailed implementation plan that includes timelines, resource allocation, data migration strategies and training. Involve key stakeholders to facilitate adoption and to hear and address concerns early in the process.
Utilize support: Work with your software provider to ensure that documents are correctly categorized, that metadata is accurately applied and that data integrity is maintained during transfer. Take advantage of any training and customer support available.
Train and communicate: Provide comprehensive training for team members to ensure they understand how to use the new software effectively. Keep the lines of communication open so employees can feel invested in and comfortable with the new changes and offer suggestions for improvements.
Evaluate: Once implementation is complete, evaluate the system’s performance and make a plan to implement any necessary adjustments or improvements.

Overcoming implementation challenges

You will see the benefits of automating document control quickly. You will also likely encounter some obstacles on the path to implementation. One of the most common hurdles to overcome is resistance to change. Employees who are comfortable with the system currently in use may balk at having to learn something new. Others may fear loss of data, time expenditure and impact on operations. Here are some ways to overcome these challenges:

Resistance to change

It is important to keep the lines of communication open from early in the software change process. Start by including representatives from all stakeholder groups in decision making. Identify and address concerns and objections early and directly, through a variety of communication avenues. Prepare your employees for how their work will change, the benefits they will see, and any software limitations of which they should be aware.

Data integrity

Ensuring data integrity throughout the process is critical, so understanding the how, what, where and who of data transfer should be discussed early on. Work with your vendor to determine what data can be translated across systems, where it will be stored, who will be responsible for transfer and how it will be accomplished and controlled.

Operational impact

While the goal is for implementation to have minimal impact on operations, a temporary shift in workflow is to be expected. The key is to thoroughly prepare and plan for potential down time. Consider workflows and essential activities. Develop a plan that times changes for the least interruption.

Employee training

Ensuring that employees are appropriately trained should be a top priority. Employees should be introduced to all of the software’s capabilities, with special attention to areas that most affect their daily work. Listen to their feedback and suggestions and be prepared to make adjustments if necessary.

Vendor support

When choosing a document control software vendor, look for a company that offers robust customer support and has received good reviews from customers. Establish a good relationship with your customer support contacts and utilize your vendor’s support resources, including call centers, articles or online learning.

Summary

Transitioning from a more manual quality system to an automated document control software like QT9’s eQMS can be a life-changing upgrade for organizations in regulated industries. The often-overwhelming task of maintaining meticulous documentation and compliance can become seamless with the right software, resulting in improved operational efficiency, reduced errors and significant time and cost savings.

QT9 can help you make the transition. Learn more about our highly rated, affordable and easy-to-use eQMS, which includes document control plus more than 24 additional applications that will simplify your quality and compliance efforts.