FDA / Part-11 Studies in KECKCap

Owned by DaniellaG
Last updated: Apr 25, 2024
3 min read

KECKCap located at https://keckcap.med.usc.edu has been thoroughly validated to ensure compliance with 21 CFR Part 11 standards.

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What does 21 CFR Part-11 Compliance mean for KECKCap?

For REDCap, achieving 21 CFR Part 11 validation means we’ve ensured the platform meets the regulatory standards outlined in Title 21 CFR Part 11 set by the FDA.

Here's what it means in practical terms:

  1. Data Integrity: We’ve ensured the integrity of electronic records and signatures. This includes implementing controls to prevent unauthorized access, alterations, or deletions of data.

  2. Security Measures: We’ve validated that robust security measures are in place to protect electronic records and signatures from unauthorized access or tampering. This involves encryption, access controls, and audit trails.

  3. User Authentication: We’ve implemented mechanisms for verifying the identity of users accessing the system and for ensuring that electronic signatures are linked to the appropriate individuals. This is the reason this system has two-factor authentication on top of Shibboleth authentication.

  4. Audit Trails: We have validated that the system maintains comprehensive audit trails that record all actions taken with electronic records, including creation, modification, and deletion, along with the date and time of each action and the identity of the user.

  5. Validation Documentation: We have officially documented and demonstrated through validation procedures that the system meets the requirements of Part 11. This documentation was shared with the FDA.

Is my study automatically compliant if I use KECKCap?

No. While a validated system is an important component of compliance, it's only one piece of the puzzle. Compliance requires a comprehensive approach that encompasses both technology and operational practices to ensure that regulatory requirements are met throughout the course of the study.

Here are some key considerations for ensuring compliance:

  1. Data Handling Procedures: The study team must adhere to appropriate data handling procedures when using KECKCap. This includes ensuring that data is entered accurately, securely, and in compliance with regulatory requirements.

  2. User Training: All users of KECKCap must be adequately trained on how to use the system in a compliant manner. This means using the correct REDCap features, user roles, and user access to ensure the proper entry of data, signed electronic records, and data integrity.

  3. Standard Operating Procedures (SOPs): The study team should have SOPs in place that outline how KECKCap will be used in the context of the study and detail the processes for data entry, review, and retention.

  4. Auditing and Monitoring: Regular auditing and monitoring of KECKCap usage are necessary to ensure ongoing compliance. This includes reviewing audit trails, user access logs, and system configurations to identify any potential issues or non-compliant activities.

  5. Regulatory Reporting: If the study is subject to FDA oversight, the study team must be prepared to provide documentation and evidence of compliance with regulations, including the use of a validated system like KECKCap.

How do I get started with an FDA Study in KECKCap?

To get started, you must first complete a KECKCap study activation request form. Once received, you will be contacted by a member of the KECKCap support team to walk you through the process.

Can I get started on my own?

No. You must consult with the KECKCap support team to ensure that all aspects of Part-11 compliance are met for your study.