What's the best 21 CFR Part 11 software in 2022?

 

There are multiple 21 CFR Part 11 software providers that can help you meet the requirements of the FDA's electronic record regulations

But a baseline of compliance isn’t necessarily maximizing value. To move to the top of your market and position your company for future growth, a thorough audit of your available options is crucial.

Don't just ask,"which platform will get me compliant?"

Ask, "which platform will help me comply and move beyond that core compliance for a modern, quality-centric approach?"

FDA guidance on software for electronic records and signatures is pretty broad. This gives you the opportunity to adopt a system which meets your 21 CFR Part 11 software requirements and unlocks additional benefits too.

For instance, 21 CFR Part 11 compliance software might also offer sharper document collaboration, smarter document control, better data security, or (ideally) all three.

While the best 21 CFR Part 11 software for your company depends on your specific business make-up and requirements, there are a few characteristics common among all of the leading options for 21 CFR Part 11 compliant software.

Let's take a look at the features and qualities you should be looking for - then dive into the market leaders offering those features.

 

Table of Contents

  1. 21 CFR Part 11 software requirements
    1. Easy validation
    2. Robust document control features
    3. Technical features
    4. Collaboration
    5. Authenticated electronic records
    6. Strong password requirements
    7. Simplicity
    8. Scalability
  2. The best 21 CFR Part 11 software options 
    1. MasterControl
    2. Trackwise
    3. Qualio

 

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21 CFR Part 11 software requirements

 

21 CFR Part 11 compliant software, in a nutshell, is any document management software that meets the US FDA's requirements for the acceptance of electronic records and electronic signatures.

These standards aim to ensure that electronic records and signatures used in your business are just as trustworthy and reliable as paper equivalents.

Current good manufacturing practice (cGMP) does not require the use of software for the submission of documents or signatures. The FDA provides only generalized guidelines about the types of technologies which can meet these requirements.

However, electronic quality management software (eQMS) with robust document management capabilities is the most common approach to meet requirements for 21 CFR Part 11-compliant software in FDA-regulated organizations such as medical device, pharma, biotech, and contract research or manufacturing organizations.

 

RELATED READING: How much does eQMS software cost?

 

If you're asking, "what's the best 21 CFR Part 11 compliant software?" you're not necessarily asking the right question.

There are no software products designed exclusively for 21 CFR Part 11 compliance. Most commonly, FDA-regulated organizations achieve compliant signatures and records through eQMS software.

Since the FDA guidance on meeting Part 11 requirements is very broad, organizations should consider other 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 extra capabilities that enhance your quality management and collaboration capabilities.

Add these to your 21 CFR Part 11 software requirements list:

 

1. Easy validation

 

Computerized system validation, now known as computerized system assurance, is required for organizations regulated by the FDA or European Medicines Agency.

Effectively, organizations must validate their computer systems, such as software used for quality management, to prove it complies with 21 CFR Part 11 and other regulations such as :

  • 21 CFR 210-211
  • 21 CFR 820
  • 21 CFR 600
  • 21 CFR 1271

 

Beyond requiring validation and providing some guidelines, the FDA doesn't provide specific instructions on how to approach validation. But they do recommend the 'least burdensome approach'.

Although organizations used to rely on documents like Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ), these no longer reflect the iterative nature of modern software validation, and the FDA encourages businesses to adopt a risk-based, critical thinking approach and work with their software providers to make validation as straightforward and logical as possible.

Nevertheless, with the wrong vendor validation can quickly become extremely complicated, especially with on-premise software systems or software which has been heavily customized to meet an organization's requirements.

If your 21 CFR 11 software contains a considerable amount of custom codes or DIY integrations with other systems, you may face operating issues or huge complexities each time you have to update the software or patch a security issue. Your vendor may offer limited support for validation, or charge a costly consulting fee for this process.

Before investing in software for compliance with 21 CFR Part 11 and other FDA requirements, investigate the vendor’s approach to software validation at the time of installation, operation, and performance, as well as built-in mechanisms for revalidation as part of the change control process. Ideally, cloud software vendors should offer simple revalidation packages as a client service.

Your software vendor should also be prepared to keep up with industry best practice and regulatory expectations, such as those laid out in the Second Edition of GAMP 5 released in mid-2022, its supporting 'Enabling Innovation' Good Practice Guide, and the FDA's stance on validation and quality management.

 

RELATED READING: 21 CFR Part 11 compliance checklist

 

2. Robust document control features

 

There's no such thing as software which can guarantee or "certify" compliance with FDA 21 CFR Part 11.

Organizations bear the responsibility of Part 11 compliance, including procedural or administrative controls such as software.

However, software which 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.

 

3. Technical features

 

Your 21 CFR Part 11 software should be able to completely manage your organization's electronic records, including document revisions and approvals with trustworthy date and time stamps.

Records should be archived per your company's policy instead of removed or deleted from the system. 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.

Finally, per FDA requirements for electronic signatures, the software should require users to enter their credentials for documents which require a legally binding signature to ensure the integrity of a user's signature.

All these features contribute to a robust ALCOA+ document approach which helps your business embed Good Documentation Practice (GDocP) as well as simply complying with Part 11.

 

ALCOA+ documentation requirements

 

4. Collaboration

 

The best compliant document control software helps organizations work more effectively by improving team communication on FDA-required documents.

This should include automated notifications and reminders for document contributors, and the ability to leave in-line comments during document revisions. Cloud-based software enables your team to collaborate globally.

The best document control features meet FDA requirements for electronic records and signatures, but they shouldn't fit the bill in a way which "feels" compliant or adds complexity to your organization's workflow.

Ideally, it should make global collaboration around trustworthy, compliant electronic documents a more streamlined and useful part of your process. 

 

5. Authenticated electronic records

 

FDA guidance for the authentication of electronic records and signatures requires that software "must employ at least two distinct identification components such as an identification code and password," according to Subpart C of Section 11.200.

Effectively, your organization needs to be prepared to prove a user's identity based on a signature if the trustworthiness and authenticity of your records or signatures are ever brought into question.

Simply providing a form for your users to type their name and the date isn't enough. Multi-factor authentication is an essential software feature for FDA 21 CFR Part 11 compliance and the security of your sensitive data.

There are several possible approaches to user authentication, which can be loosely categorized as the following:

  • Type 1 - "Something You Know" - Passwords, PINs, or secret questions
  • Type 2 - “Something You Have” - Texting a Code to a Mobile Phone
  • Type 3 - “Something You Are” - Biometric validation of fingerprints or retinas

 

A software should require, at a minimum, that users enter their password or a PIN before creating an electronic signature.

Depending on your organization's requirements, you may choose to increase security by moving to a multi-factor authentication model which includes a mobile phone text or validates the user's device.

Ask a prospective software company how they verify a user's identity to ensure trustworthy electronic signatures, and how this information is reflected in the audit trail.

 

6. Strong password requirements

 

21 CFR Part 11 requires that organizations establish "access control" to closed systems and create an audit trail, but provide little guidance on specifics.

Each user account which has access to the system must be associated with a unique username and password combination, and per FDA guidance, organizations should maintain access control by creating username and password combinations which limit a user's data access and capabilities based on their role.

Currently, there are no recommendations on adopting software which requires strong passwords or periodic password changes.

Just meeting the FDA's non-aggressive guidance for passwords is likely to present a liability to your organization's data security.

In fact, 80% of information security incidents with data loss involved weak or stolen passwords, according to the Verizon DBIR. Weak passwords can present an enormous risk that compromise your organization's data security.

Lazy passwords can be easily guessed or shared by colleagues, which may not have malicious intent. In some situations, coworkers may use a colleague's account since it's "easier" than asking for different permissions or a password change. However, these innocent workarounds compromise the authenticity of records and signatures and the trustworthiness of your audit trails.

Your software should include features to enforce effective password policy, including:

  • Unique passwords
  • Password encryption
  • Enforced password selection
  • Password expiration
  • Security questions

 

Users should be required to choose a new password every 30-90 days, which consists of a unique combination of letters, numbers, and special characters.

The software should also lock user accounts when an incorrect password is entered repeatedly.

Ensure prospective vendors don't offer weak security policies around user passwords, such as a policy of emailing lost passwords directly to a user instead of enforcing a password change.

 

Qualio 21 CFR Part 11 password protection

 

RELATED READING: 4 Part 11-compliant document management systems you should know about

 

7. Simplicity

 

Compliance with 21 CFR Part 11 and other FDA cGMP can be complicated.

However, your software shouldn't feel add unnecessary burden or effort to your company's quality management processes.

It also shouldn't feel like a compliance software or a product which adds laborious steps to your workflows. It should make compliance fade into the background of a user-friendly product for collaboration and natural, automatic quality management.

A simple product should help your organization exceed requirements and adapt with agility to new cGMP requirements.

The definition of software which offers "simplicity" can vary significantly depending on an organization. A product which is the right type of "simple" for a start-up could be far too lightweight for an enterprise with a vast catalog of approved products for market.

However, some general signs that a product is "simple" are:

  • Clean, flat UX
  • Broad functionality set that makes one product suitable for multiple uses i.e. document, training, event management
  • Linked processes for end-to-end process visibility
  • Customized workflows and features to streamline quality management processes
  • Built-in validation and revalidation packages
  • Simple, closed-loop reporting for continuous improvement
  • An intuitive, user-friendly software experience on desktop and mobile

 

If your organization is evaluating software for compliance with FDA 21 CFR Part 11, consider the time-to-value as a component of simplicity.

How easy is the software to activate?

How much engineering and configuration is required ahead of time?

Ideally, the platform should require minimal customization, aside from configurations to meet your organization’s requirements.

To achieve compliance and other possible benefits quickly, fast-track cloud software vendors that offer a quick implementation and value out-of-the-box.

 

8. Scalability

 

The ability to scale software to company growth and new FDA requirements is a critical feature, especially at fast-growing scale-ups and start-ups in FDA-regulated industries. If your organization is in the pre-market phase of researching and developing new products, your system will need to scale to new capabilities, such as The software should offer the capabilities to scale to new:

  • Users
  • Work sites
  • Products
  • Clients
  • Suppliers
  • Processes
  • Workflows

 

Also, to provide the capacity to scale, a software vendor should make it affordable for clients to grow. A final component of scalability is the capability of the software to integrate with existing systems or easily transfer to a new system.

 

The best 21 CFR Part 11 software options 

 

Several vendors offer software with each of these must-have features outlined above.

Remember: the best software for your organization is the one which helps you maintain continuous compliance with FDA cGMP and matches your other requirements for budget, ease of use, and speed of implementation.

 

1. MasterControl

 

mastercontrol-1

 

MasterControl is a total quality management suite with broad adoption among enterprise customers, including several major regulatory agencies.

This solution is focused on helping large organizations manage large global portfolios of products, bring new products to market at greater speed, and increase organizational efficiency.

User reviews report satisfaction with linked quality processes and extensive document control capabilities.

This software is likely best suited for substantial enterprises, due to user-reported extensive requirements for configuration, a reported high cost, and a steep learning curve which may require vendor-supported training.

 

2. Trackwise

 

TrackWise

 

This software is positioned as an 'out-of-the-box' solution for compliance, which is built on the Salesforce platform.

Users can gain access to prebuilt workflows, validated product releases, and built-in compliance with 21 CFR Part 11.

Client reviews on G2 Crowd report satisfaction with the product’s prebuilt offerings for workflows and the software’s ability to efficiently scale existing workflows and documents to new processes.

Users report dissatisfaction with the vendor’s post-sale service and customer support.

 

3. Qualio

 

 

Qualio is the first cloud-powered eQMS designed to embed natural, automatic compliance with FDA 21 CFR Part 11, Part 820, ISO 13485, GxP and more.

Over 500 start-up and scale-up life science organizations in 80 countries use Qualio to not only comply with 21 CFR Part 11, but to build a robust document management system within a broader digital quality framework.

Qualio provides the full gamut of world class document management features, from audit trails and e-signatures to templates, traceability and cloud-based access. But Qualio is also designed to connect your document library to the rest of your quality management system through 

User reviews report superior client support from the vendor, a comprehensive feature set, and a natural, intuitive user experience which maximizes adoption.

 

Next steps

 

Balance your 21 CFR Part 11 software requirements with features like easy validation and robust document control before you make a final decision.

Ensure a vendor is the right size for your company's current size, budget, and growth goals to avoid an overly costly investment, complex implementation, or a product which can't scale.

And then...

Schedule a demo to ask questions, dive into the product offering and ensure you've selected the best 21 CFR Part 11 software for your needs!