Contract Logix Adds Support for FDA 21 CFR Part 11

Leading Contract Management Software Provider Delivers Enhanced eSignature Capabilities to Help Life Sciences Organizations Simplify Compliance with Critical Regulatory Requirements

Lowell, MA – October 12, 2022 – Contract Logix, a leading provider of intelligent and data-driven contract management software, today announced support for FDA 21 Code of Federal Regulations (CFR) Part 11, which details the criteria under which electronic records and signatures are considered to be trustworthy and equivalent to paper records. These enhancements to Contract Logix’s platform further demonstrate its commitment to helping the life sciences industry digitally transform contract lifecycle management (CLM) with a security-first approach to delivering high quality and compliant services to pharmaceutical, biotechnology, and healthcare clients.

Key Facts:

  • 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.). Contract Logix’s e-sign enhancement provides signature-level credentialing, meaning and manifestation. Its CLM platform also 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.
  • 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.
  • 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.

Executive Comments:

  • “Security and speed are especially critical in the life sciences industry. The CFR Part 11 eSignature support added to our already-robust no-code platform will further help these organizations rapidly and digitally transform the way they manage contracts while ensuring the right level of compliance throughout the entire contract lifecycle.”
      • Tim Donaghy, CTO, Contract Logix
  • “The volume of contracts and contract data generated by life sciences organizations is staggering, and the use of eSignatures can help speed up complex contract management processes. We’re committed to working with our customers to ensure that our platform complies with the most up-to-date industry security certifications, practices, and regulatory requirements to protect their contract information and help mitigate risk.”
      • Karen Meyer, CEO, Contract Logix

Additional Information:

About Contract Logix

Contract Logix is a longtime leader, innovator, and provider of intelligent and data-driven contract lifecycle management software to the life sciences industry. The company’s software empowers legal, administration, IT, procurement, finance, and sales professionals to digitally draft, negotiate, approve, execute, and manage their contracts. Hundreds of brands have partnered with Contract Logix to automate and streamline their contracting processes while minimizing risk, increasing compliance, and driving profitability. For more information about Contract Logix, visit www.contractlogix.com and follow us on LinkedIn.

Menu