Source: https://www.qualio.com/blog/best-21-cfr-part-11-compliant-software
Timestamp: 2019-06-17 08:50:43
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21 CFR Part 11 compliant software meets the US FDA's requirements for the acceptance of electronic records and electronic signatures, based on standards which ensure these electronic records and signatures 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 at FDA-regulated organizations in pharma, biologics, and the life sciences industries.
If you're asking "what is 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 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.
Software validation is required for organizations that are subject to compliance with the FDA or European Medicines Agency. Effectively, organizations must validate software systems, such as software used for quality management or document control, for compliance with 21 CFR Part 11 and other regulations such as :
21 CFR 210-211
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." Most organizations choose to undergo a series of three documented tests; Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ). Also, many organizations choose to integrate validation into change control processes to ensure the software isn't operating after an upgrade or significant change to the quality management system without validation.
Validation can quickly become extremely complicated, especially as it concerns legacy systems, on-premises 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 FDA compliance software vendors should offer simple revalidation packages as a client service.
Also, your software vendor should be prepared for upcoming changes to compliance-required processes. In the next few months, the FDA will be releasing a long-awaited update to industry guidance for software validation. Ensure your vendor is prepared to meet emerging regulatory requirements.
RELATED READING: A Printable 21 CFR Part 11 Compliance Checklist
Robust Document Control Features
There is no such thing as a 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, a 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.
The 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.
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.
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.
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 a recent year, 80 percent 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 external threat actors compromise your organization's data security.
Also, weak passwords can present internal security risks. 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:
Enforced password selection
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 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 software company with a policy of emailing lost passwords directly to a user instead of enforcing a password change.
Compliance with 21 CFR Part 11 and other FDA cGMP can be complicated. However, your software shouldn't feel involved or add weight 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 excellent quality management. A simple product should help the organization exceed requirements and adapt to new cGMP.
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 startup 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:
Comprehensive features for total quality management and FDA compliance
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.
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. 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 CAPA and customer complaints. The software should offer the capabilities to scale to new:
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.
21 CFR Part 11 Compliant Software Options with These Features
Several vendors offer software which meets each of these must-have features outlined above. 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.
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.
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.
Qualio is the first cloud eQMS designed per the latest FDA cGMP. The product is designed for compliance with FDA 21 CFR Part 11, Part 820, ISO 13485:2016 and ISO 14971 and offers compliant records and signatures across automated, linked quality processes. Small-to-midsized life sciences organizations can achieve total traceability, superior collaboration, and continuous improvement while exceeding compliance requirements with a product that’s designed for simplicity and scalability. User reviews report superior client support from the vendor, a comprehensive feature set, and intuitive user experience.
Evaluate possible options for compliance with 21 CFR 11 against features like easy validation and robust document control before you make a final decision. Ensure a vendor is right-sized 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. Before you make a final selection, schedule a demo and trial to ensure you've genuinely selected the best FDA compliance software for your needs.
Click here to request a demo of Qualio.
Published by Robert Fenton May 30, 2019