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How to Comply with FDA 21 CFR Part 11?

01 Aug 2023

Table of Content


For highly regulated industries like medical device manufacturing and life sciences, meeting compliance with FDA 21 CFR Part 11 has always been challenging. Being CFR Part 11 compliant implies that organizations follow best practices for managing the documentation and quality management processes. It is no longer possible with traditional document management systems. It even requires more administrative time, effort, space, and resources to maintain paper-based records for a longer time.

That’s why, FDA recommends organizations implement and use electronic quality records and electronic signatures in place of traditional paper-based systems to comply with FDA 21 CFR Part 11, which is way faster, better, and efficient.

Realistically, CFR Part 11 applies to pharmaceutical manufacturers, biologics developers, medical device manufacturers, biotech companies, and other FDA-regulated industries, with some specific exceptions. It requires them to implement controls for all the quality processes, including audit trails, internal audits, system validations, electronic signatures, and documentation to process the electronic data that the FDA requires them to maintain. You can utilize advanced document management software to gain more control and confidence in managing documentation quickly and compliant.

Before we move on to the discussion on the type of document management software you should choose to Comply with FDA 21 CFR Part 11, it will be sensible to understand the FDA Specific Part 11 Requirements first that require organizations to have controlled documents for:


Validation of the quality systems is critical to ensure consistency, accuracy, and reliability. In simple words, you need proper documentation to define the elements and their intended functions to validate their functionality at regular intervals of time. It may feel overwhelming otherwise.

Having controlled documents for validating eQMS reassures data security and the activities performed on it while increasing the integrity of your document management systems. The advanced document management software enables you to create error-free and consistent validation scripts that ensure all your quality teams are on the same page regarding the process or system validation while meeting compliance requirements. The software also keeps track of all the validation activities by maintaining the records on a centralized platform.

Audit Trails

If you want to meet compliance requirements for FDA 21 CFR Part 11, you must use secure, computer-generated, time-stamped audit trails. It will help you record the date and time of every entry and action, whether you created, modified, or deleted the electronic records. It would help to implement a powerful and scalable document management software that can automatically track the processes and keep them documented for audits or regulatory inspections.

Also, these audit trails should not be modifiable. It can be possible only when you use an automated system. Most importantly, system-generated records hold much more integrity than traditional paper-based records. It maintains a log of events (including change requests, revisions, and deletion) sequentially with E-Signatures on them.

Legacy Systems

There are specific systems that are critical for everyday operations in any organization, even if they are not modernized. Maintaining these systems and the relevant documentation is a real challenge since the documentation shall demonstrate the following details:

Whether the system is operational

What are the updates and changes done?

Integration and compliance details and much more.

You can utilize the new-age, integration-enabled document management software that seamlessly integrates with all the existing quality systems to control the business-critical information.

Copies of Electronic Records

In addition to maintaining an audit trail, you also need to retain the copies of electronic records to comply with FDA 21 CFR Part 11. These records should also be easily accessible. Credit to the technological advancements that have made document management much simple and straightforward. You can easily maintain and manage copies of your document records.

The document records can be easily held with compliance to the regulatory requirements.

The best solution here to manage documentation in compliance with FDA requirements is a cloud-based document management software that comes with:

Operational Controls

A sophisticated Enterprise Quality Management System allows organizations to monitor and control the quality procedures utilizing the ‘phase gating.’ It further ensures that the individuals review the controlled documents and that they meet all the relevant requirements before they sign off. The right eQMS solution will offer enterprises a readily accessible platform to access, share, and track business-critical information.

The advanced document management software comes with capabilities such as Email Notification and Approvals, real-time Collaboration, and Electronic Signatures to accelerate the document review and approval process. The review process allows organizations to ensure the adequacy of the information before publishing the same.

An eQMS also allows organizations to maintain and follow the industry best practices – be it effectiveness review task or executing a change request. In simple words, you can control all the document related activities in a compliant and standardized manner as specified in the regulatory requirements for controlled documents.

Advanced Security Controls

Data security is another essential aspect if you want to comply with FDA 21 CFR Part 11. It requires you to have proper security controls in place for your controlled documents and business-critical information. The traditional document management systems are not safe enough to store any sort of confidential information related to your business or customers. That’s where the advanced document management software has a competitive edge.

You can leverage the better data security controls with E-signature, password authentication, and role-based security that next-generation document management software offers. Would you still prefer the traditional document management systems that are more vulnerable to the security threats?

E- Signature

The requirements regarding the use of electronic signatures are clearly defined in Part 11. It says, “A digital signature is an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified.”

The FDA allows and recommends electronic signatures to be used on electronic documents in place of ‘wet signatures’ on paper documents to streamline and standardize the business activities. To be compliant, the electronic records must include the printed name of the signer, the date/time it was signed, and the electronic signature’s intention.

A good Enterprise Quality Management Software provides administrators more control and visibility on the use of electronic signatures across the quality systems. The software also allows you to enable and disable electronic signature requests for different roles where signatures play a guard against fraud.

Integration Controls

Integration controls are also a critical requirement if you are looking for next-generation quality management software since a single document needs to be accessed at multiple locations for multiple reasons. Your document management software shall seamlessly integrate with all the existing quality systems to provide your QC teams more control over the documents and information being shared across the organization.

With advanced integration controls, you can create a closed-loop system to manage your quality processes and data.

Minimum Training Requirements

Part 11 clearly defines that all the system users should undergo the necessary training required to perform their assigned tasks and projects. With the cloud-based and intuitive eQMS, the users can efficiently produce, manage, and track the controlled documents with minimal assistance and training requirements. 

Suppose you are among the medical device manufacturers who wish to enter the competitive and lucrative US market. In that case, you must implement the eQMS, which is specifically designed to deal with all the regulatory challenges without any critical training requirements. It will undoubtedly transform the complicated process of document management into a simpler one.

And the truth is that it will be a worthy investment for multiple reasons because the eQMS will deal with the quality and compliance challenges and bring in the new tools and technologies to accelerate the document management processes, ensuring minimal to zero errors.

The single stop solution that meets all the requirements mentioned above to help you manage and maintain regulatory requirements for proper documentation is Qualityze Document Management Software.

Qualityze Document Management is a cloud-based, intuitive software that helps enterprises create critical documents such as SOPs, Training collaterals, and more using the standardized document type templates to ensure a consistent flow of information. It comes with configurable workflows so you can add or remove the form fields as desired.

You can also utilize its advanced security controls to enable security at the document, user, and or group level through multi-level profile-based access controls, ensuring that only authorized people can access the controlled records. It also supports watermark capability to demonstrate validity, credibility, and reliability of the printed information to meet compliance requirements for controlled documents.

Moreover, it seamlessly integrates with Change Management and Training Management to make the document, change, and training management processes much simpler and straightforward.

If you also want to establish and maintain an effective document management system to meet the compliance and business requirements, get in touch with the Qualityze Customer Success team today on 1-877-207-8616 or write to us on, and we will be right there for you.



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