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The Best 21 CFR Part 11 Compliant Software Has These Features

The Best 21 CFR PART 11 Compliant Software

If your company is required to adhere to FDA 21 CFR Part 11 compliance, a document management system can make this process simple. However, not every system is built the same, and there are certain features your company should look for in a DMS before you trust it with your compliance needs. Since the FDA guidance on meeting Part 11 requirements is very broad, it is important to consider concepts like productivity and agility in a software selection decision. The best 21 CFR Part 11 software offers features for FDA-compliant signatures and records, as well as capabilities that enhance total quality management and collaboration in highly regulated organizations. Let’s take a closer look at the most important features and capabilities the most valuable system options have to offer.

The Best 21 CFR Part 11 Compliant Software Has These Features

Easy Software Validation

The first thing your company should look at in a DMS is the validation process. Validation can be extremely complicated and hard to keep track of, especially as it concerns legacy systems, on-premises software systems, or software which has been heavily customized to meet an organization's requirements. If the DMS you choose contains a considerable amount of complicated codes or custom integrations with other systems, you will most likely constantly face functional issues or complexities each time you have to update the software or resolve a security issue. Your vendor may offer limited support for validation or charge a costly consulting fee for this process.

Before definitively choosing a software, investigate how the system will be validated not only at the time of installation, but also during operation, performance, and the periodic revalidation process that is included in the change control procedure. Choosing a DMS with cloud FDA compliance capabilities is often the best choice, as these systems generally include a simple revalidation packages within their client services. With the cloud, instead of compliance being a constant burden for your company, the regulatory stress will be placed entirely on your vendor. This allows you to focus on your bigger business goals and leave 21 CFR Part 11 worries to the people who know the ins and outs of the requirements.  

Using ENSUR, your company can find all of these important features in one document management system. Our staff of validation experts have assisted many types and sizes of companies with software validation services. Our validation services include:

  • IQ, OQ and PQ services
  • Validated software planning
  • Remote OQ validation services
  • OQ scripts and validation documentation package
  • PQ procedure development
  • PQ procedure development consulting
  • Remote IQ Execution Services
  • Remote OQ Execution Services
  • PQ Execution

Whether your organization insists on doing it yourselves, requires assistance or complete turnkey validation services, DocXellent is there for you under any approach.

Strong Document Control Capabilities

A software that provides the necessary support for 21 CFR 11-compliant electronic records and signatures is likely to have robust document control features, including revisions tracking and audit trails. The best software includes both technical and collaboration features to meet requirements and help your organization work more effectively.

The software should be able to completely manage your organization's electronic records, including document revisions and approvals with date and time stamps. And, the software should provide a comprehensive audit trail of all document actions, including how users or groups of users have interacted with documents, and document workflows.

Along with our validation process, ENSUR offers strong document control capabilities. Our software is built by seasoned computer science and IT educated professionals that follow the procedures of our internal Software Quality Assurance program. Established over 10 years ago, our software quality assurance program is documented and controlled using our ENSUR document control and software quality assurance training application. The ENSUR document control process includes many policies and procedures that include but are not limited to:

  • Software Quality Assurance Procedure
  • Backup & Contingency Procedures
  • Audit and Periodic Review of Quality Assurance Program
  • Change Control Procedure
  • Computer Maintenance and Security Procedure
  • Support Tracking & Resolution
  • Network Security

We host document control software that is strong enough to tackle any compliance issue your company may face.

Collaboration features

Another important feature for Part 11 compliance is collaboration. Collaborating on a project can be challenging, especially when many different parties are involved. The best compliant document control software make it easy to create and edit documents directly within their systems. And, the capability to receive automated notifications and reminders for document contributors as well as the ability to leave in-line comments during document revisions helps your entire team keep up with the most current version of your most important documents.

Luckily, our ENSUR software is built around collaboration. Within our workflow tools, managers can start a task workflow on any document, selecting specific action items. These tasks can then be assigned to other users on the system with a due date and priority level. All users involved in the workflow will be notified as tasks are completed. Workflows in ENSUR allow teams to work together around the clock in accordance with an established structure of responsibility, even when managers are not logged in. And, using our cloud capabilities, your team can access the software from anywhere and collaborate globally.


The ability to scale software to company growth and new FDA requirements is a critical feature, especially at fast-growing scale-ups and startups in FDA-regulated industries. What works for you now needs to work for you as your business inevitably grows and changes. The software you choose should offer the capabilities to scale to things such as new users, work sites, products, suppliers, and clients.

In addition to providing the capacity to scale, a software vendor should make this process affordable and simple. The additional software capability should not be way out of your desired budgetary restriction. And, the ability to integrate with existing systems or transfer data to a new system should be an easy process. This way, your company can grow and change without dealing with the pain and excess cost that comes with a software that does not offer affordable scalability options.

With ENSUR, your company has plenty of room to grow with our software. In fact, ENSUR Cloud can grow to virtually unlimited size and DocXellent provides any added storage you may need. We offer you the ability to get started with the features and functions you need and then roll-out other modules at your own pace. Our quality software product comes out of the box without the need to upgrade or buy individual modules as your needs expand. If your initial need is for document control, but you later determine you need Training Management, CAPA, or Change Management, you can quickly and easily add these functions to your workflow without any delay or extra cost.

For more information on what makes our document management software and services different from our competitors in terms of helping your company remain 21 CFR Part 11 compliant, contact us today.

Tags: 21 CFR compliance, Compliance, Document Compliance Software