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How Can a Document Management System Help You Achieve FDA Compliance?

How Can a Document Management System Help You Achieve FDA Compliance?

The Connection Between Using a Document Management System and FDA Compliance

Labs that receive FDA warning letters must waste valuable resources to become compliant again and resume work. The time, energy, and money used to compensate for FDA warning letters are better spent on continuing the lab’s research. One way to ensure you’re on top of FDA compliance is by using a quality document management system (DMS).

Document management systems allow you to organize and update files in an instant. So, you’ll always know where to find your records and when to renew them. On inspection time, a document management system keeps you prepared for everything. But there are other ways a document management system can keep your lab running smoothly. Read on to learn more about how it can make your lab more efficient and FDA-compliant.

What Is Document a Management System?

Document management software helps businesses of all sizes manage their documents. They provide digital solutions for managing paper-based documents and other electronic content.


Moreover, a DMS allows users to easily store, share, edit, and retrieve secure information. The ability to search and filter documents ensures that teams can find the correct data with minimal effort.

Some DMS have features like version control and user access control. These security measures allow you to keep all your documents on the DMS while only allowing access to approved individuals.

Document management systems are a powerful tool for managing information and staying compliant. A DMS is essential to any lab’s compliance plan by streamlining operations and storing data.

Importance of Document Management System

Document management systems are essential for laboratories that need to achieve FDA compliance. Here are a few benefits laboratories can gain from implementing a DMS:

1. Easy Access to All Your Documents, No Matter Where You Are or Your Device
A DMS provides a secure, centralized repository for all your lab documents. Thus, eliminating the need for many copies of each document. Such a system makes it easy to locate the information you need when you need it.

2. Streamlined Document Collaboration
A document management system enables real-time collaboration on any project. You can share secure files with colleagues, even those who aren’t in the exact physical location. Plus, it assures that everyone is accessing and working off the most up-to-date document version.

3. Improved Organization and Compliance
Automating document management is significant for compliance. That’s because the FDA requires labs to maintain records in a specific format.
So, a sound document management system goes beyond maintaining records. It also gives you automated FDA compliance tools. For example, a DMS with predictive analytics can help you correct compliance errors before they happen.

What to Look for in an Integrated Document Management System

The quality of document management systems varies depending on what they offer. Choosing the best system means looking for features like:

• Secure credentials
• Templates and forms
• Electronic signatures
• Real-time document collaboration
• Automated document lifecycle processes
• Predictive compliance tools

Cost considerations may impact choosing a DMS with all or some features. But all of them combined will help you ensure your lab stays organized and FDA compliant. Swift access to necessary documents will help during FDA inspections and day-to-day operations.

Challenges in FDA Compliance

The FDA has strict regulations for labs throughout the research and development process. They wish to ensure that all labs adhere to the highest safety and accuracy standards. This includes specific rules on:

• Laboratory operations
• Data integrity
• Equipment maintenance
• Document control
• Record-keeping

Lab workers must follow these regulations to reduce compliance risk. Unfortunately, these stringent rules make meeting FDA compliance challenging for lab managers and supervisors.

The main challenge posed by FDA regulations is staying on top of them on top of other responsibilities. Lab managers and supervisors oversee many moving pieces to ensure operations run smoothly. Maintaining compliance adds to their workload.
Technological innovations like DMS software can help lighten the load. The first step to facing compliance challenges is understanding how a DMS can help you achieve FDA compliance.

How Can a Document Management System Help You Achieve FDA Compliance?

Achieving and maintaining FDA compliance is essential for every research laboratory. But managing documents in a compliant manner can take time and effort. Some ways a document management system will help your lab achieve FDA compliance are:

Track and Record Changes to Documents

Document management systems track changes and maintain previous versions for your perusal. So, you’ll have a detailed record to ensure all changes maintain compliance.

Automate Document Reviews

Document reviews are essential to FDA compliance but can be tedious and time-consuming. An electronic content management solution automates the process, making it much more efficient.

Enforce Consistent Document Standards

Consistency is critical when it comes to FDA compliance. An electronic content management system ensures that all documents follow the same standards and stay compliant.

Access Documents When Needed

Quick and efficient access to documents ensures your team can handle inquiries or audits. An electronic content management system makes it easy to access documents when needed.

How ECM XD Can Help

Now you know why a document management system is necessary for a lab environment. But there are so many options available that it takes time to decide which. We want to offer you the opportunity to try ECM XD. ECM XD is dedicated to streamlining your document management for FDA compliance in the following ways.

Document History, Security, and Auto-Fill

These premier ECM XD features will become essential time-savers in your lab. But they’ll also help ensure FDA compliance. Our software allows you to keep track of your document history so you have detailed records. 

Also, autofill is excellent for avoiding human error. No longer will you fall victim to the fat finger of non-compliance. With autofill options, you enter the correct information every time.

Metatags and Organization Tools

FDA inspections call for quick retrieval of relevant documents. Traditional file-folder systems make it easy for you to misplace documents. But cloud-based software like ECM XD allows easy, instant document retrieval anytime, anywhere.

Document Lifecycle Management

Expired documents are one of the quickest ways to fall out of the FDA’s good graces. But, with so many documents on hand, keeping track of expiration dates is a serious hassle.

With ECM XD’s document lifecycle management, you no longer have to worry about remembering expiration dates. The software keeps track of publishing and expiring documents for you. Plus, it reminds you before the document expires, leaving you plenty of time to renew it.

Offline Workplace for Total Access

Part of maintaining compliance is ensuring your documents are up to speed. But many labs have adapted to hybrid work environments that benefit the company and its employees. So, remote workers need more access to documents than ever before.

Luckily, a DMS like ECM XD can solve that problem. Our software allows anyone to access and create documents even if they don’t have an internet connection. So, even remote workers can help you stay on top of FDA compliance.

Intuitive Operation

The ECM XD system is so intuitive you’ll find reduced instances of errors in your record-keeping. Reduced errors lead to improved employee health and safety. But it also increases worker productivity and collaborative efforts.

Plus, ECM XD is a try-before-you-buy service. You can try our risk-free demo at no cost before committing to our DMS.

Try Xybion’s ECM XD Today

A sound document management system is essential for research laboratories to achieve FDA compliance. But the best document management system will also increase productivity and streamline processes.


ECM XD is the best system available for managing electronic content. Our innovative software provides a comprehensive set of tools to ensure FDA compliance while streamlining document management in the lab. By automating manual processes and reducing the need for physical storage space, ECM systems can help organizations to reduce operational costs. Try ECM XD today with a free demo and see how it can make your job easier.


Ready to learn more? Book a demo with us!