Why FDA 21 CFR Part 11 Compliant Contracting Software is Critical for Life Sciences Organizations

Oct 12th, 2022

Extensive clinical trials, complicated payer and provider agreements, evolving supply chain dynamics, and ensuring compliance without compromising speed are real contract management challenges facing the life sciences industry. The result of all these activities creates a staggering volume of contracts and contract data generated by life sciences organizations, and the use of eSignatures can help speed up complex contract management processes. Food and Drug Administration (FDA) 21 Code of Federal Regulations (CFR) Part 11 details the criteria under which electronic records and signatures are considered to be trustworthy and equivalent to paper records. Read on to learn more about this important regulation and how Contract Logix’s contract lifecycle (CLM) management software for life sciences organizations supports it.

Key Takeaways

  • FDA 21 CFR Part 11 ensures that electronic records and signatures are authentic
  • Contract management software designed specifically for life sciences organizations can ensure that all contracts meet FDA 21 CFR 11 requirements as well as compliance with all other key regulations like HIPAA and SOX

What is FDA 21 CFR 11?

The FDA released the regulations in 1997 to provide guidance on the use of electronic systems and criteria in which electronic signatures, records, and handwritten signatures captured for an electronic record are considered “equivalent to paper records and handwritten signatures executed on paper.”  Unfortunately, the guidelines were so complicated that many life sciences organizations stuck to paper records. New guidelines were released in 2003 to make the rule easier to follow while still addressing some of the biggest risks related to electronic records.

FDA 21 CFR Part 11 applies to any records in electronic form that are created, modified, maintained, archived, retrieved, transmitted, or submitted.

To be compliant, signatures must include a printed name, date, time, and reason for the signature (review, approval, responsibility, authorship, etc.).

Who Does It Impact?

Regulated companies with any documents or records in electronic format that submit records to the FDA for inspection must comply with the regulation. This affects a number of life sciences personnel including scientists, researchers, clinical trial sponsors and assistants, medical device manufacturers, nurses, investigators, among others.

How Can CLM Software Support Compliance with FDA 21 CFR Part 11?

Streamlining and automating buy-side and sell-side contracting processes for clinical trials, contract manufacturing, rebate tracking, and more gives life sciences organizations complete visibility into all contract types as well as the ability to identify opportunities to improve contract performance. In addition, CLM software like Contract Logix help these organizations enforce business processes with automated workflows to manage compliance and appropriate contract, product and multi-department approvals, and maintain accurate and real-time audit trails for FDA compliance.

Contract Logix’s CLM platform supports an “out-of-the-box” configuration specifically designed to support the unique contract management requirements of life sciences organizations to help them get up and running and realizing value quickly. New e-sign enhancements to the platform provides signature-level credentialing, meaning and manifestation specifically designed to support FDA 21 CFR 11. They also further demonstrate our commitment to helping the life sciences industry digitally transform CLM with a security-first approach to delivering high quality and compliant services to pharmaceutical, biotechnology, and healthcare clients.

Contract Logix provides a powerful set of security capabilities in the software including SOC 2 Type II and HIPAA compliance, roles and feature-based permissions, data encryption at rest and in transit, disaster recovery, logical separation of all customer data, multi-factor authentication (MFA), single sign-on (SSO), and other security-related functionality. Automated workflows in the platform efficiently follow internal and regulatory policies for contract reviews and approvals to further ensure compliance. In addition, the platform’s automated alerts eliminate missed contract obligations and dates, and automated document versioning accurately tracks contract revisions and changes, simplifying risk management and audit readiness.

Let Contract Logix Help Ensure That All Your Contracts are Compliant

Contract Logix has over a decade of experience working with life sciences organizations to streamline, automate, and digitally transform their contract processes, as well as satisfy intense regulatory compliance requirements. The platform’s security-first approach safeguards all contract-related patient, supplier, payer, and provider data from unauthorized access, and electronic signatures provide a legally binding, time-and-date stamped audit trail of approvals that can be used to demonstrate compliance.

Contact Contract Logix today to learn more about 21 CFR Part 11 compliant contracting software for your organization.

Schedule a contract management software demo with Contract Logix.

Looking for more articles about Contract Management? Check out our previous article “Jumpstart the Contract Journey: Assemble Negotiation-Ready Contracts Faster“.