Forte’s Approach to Development: 21 CFR Part 11 Compliance

Anna Hrovat-Staedter
May 1st, 2018

The clinical research industry’s complex regulations and requirements are difficult to navigate, but serve an important cause. Forte’s development approach is to not only navigate industry regulations but to serve and assist our community in succeeding within the highly-regulated clinical research environment. An example of this is our development and launch of systems that support 21 CFR Part 11 compliance.

We’ve heard from our customers that software vendors will occasionally approach them with the promise of a 21 CFR Part 11 validated system. While this promise may resonate with researchers, it is ultimately the role of the institution, not the vendor, to validate their systems. However, a technology provider like Forte can provide assistance during the customer’s path toward validation. This article introduces Forte’s role and our customers’ roles in this process, highlighting how vendors and researchers can work together to ensure compliance.

What is 21 CFR Part 11 Compliance vs. Validation?

Introduced in 1997, the FDA released part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures, commonly referred to as 21 CFR Part 11.1 This regulation defines requirements to ensure that electronic records and signatures are equivalent to paper records. Compliance with 21 CFR Part 11 ensures that an application meets the technical requirements of the regulation. Validation of an application ensures that an organization has both compliant software and processes in place to ensure that the software is used in a Part 11 compliant manner.

Our Approach

As Forte’s OnCore Enterprise Research System grew and was adopted by leading research organizations throughout the nation, many of our customers expressed a need for 21 CFR Part 11 compliance for specific workflows. Forte’s strategy has been to develop independent products that meet the needs of those specific workflows requiring 21 CFR Part 11 compliance. This strategy allows customers to implement and validate only the products needed for their specific workflows. Having independent applications also allows each product to be upgraded and validated independently. Integration between our products allows for a streamlined workflow between systems.

Our first product to adopt this strategy was Forte EDC. As the first fully 21 CFR Part 11 compliant application developed by Forte in 2013, it supported part 11 compliance with features like audit trails, electronic signatures, cross form constraints and more. After we released our 21 CFR Part 11 Compliant EDC, we turned our attention to expanding functionality, and developing resources to support customer validation efforts.

We were then able to leverage the knowledge and experience gained through creating Forte EDC to develop our eRegulatory management system, Forte eReg, released in August of 2017. Along with a number of customer collaborators, we developed eReg to address researchers’ biggest regulatory challenges and create new efficiencies by bringing common regulatory tasks to the system level. Forte eReg features a master delegation of authority, a remote monitoring portal and 21 CFR Part 11 compliant electronic signatures.

Validation Resources

Validation of systems can be time-consuming and challenging for our community organizations. To ensure EDC and eReg users are slated for success using our systems, Forte developed efficient services and sustainable resources to not only get customers up and running in a validated system, but also to assist in maintaining that status throughout each upgrade.

Forte EDC’s Implementation and Validation Services results in a validated, centralized source for all investigator-initiated trial data. The 10-week approach encompasses implementation, validation, legacy form template building and study build activities. Forte also offers a Validation Packet Subscription, which provides organizations with resources like a Traceability Matrix, Test Suite Approvals and an Installation Qualification Report to reduce testing burden.

Our Forte eReg Document Migration Services minimize the maintenance of regulatory binders in multiple formats, which can complicate and lengthen on-boarding and training of new staff, decrease turnaround time for implementation, enable a broader scope for implementation and provide an opportunity for organizations to review migrated documents. eReg also offers a Validation Packet Subscription, providing similar documents and resources to reduce the testing burden.

Moving Forward

Our strategic approach has allowed us to continue to provide our community with the necessary tools to keep up within ever-evolving industry, as well as launch multiple products that support 21 CFR Part 11 Compliance. While we realize that we alone can’t provide a validated system, we are working to make it a seamless experience for our customers. As we look to the future, we will proudly use this well-established base to continue to expand our solutions and services for our community.


Learn More

Want to learn more about the roles organizations and vendors play in validating an EDC system? Watch our on-demand webinar, Understanding, Achieving and Maintaining 21 CFR Part 11 Compliance.

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Understanding, Achieving and Maintaining 21 CFR Part 11 Compliance

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