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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.
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.
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.
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.
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
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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.
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Can I get started on my own?
No. We strongly recommend you You must consult with the KECKCap support team to ensure that all aspects of Part-11 compliance are met for your study.
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