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Cloudbyz recognizes the significance of maintaining accurate, data-integrated electronic records and meeting regulatory demands through an audit trail. Hence, our eClinical platforms incorporate robust audit trail features and electronic signatures, empowering customers to monitor all activities within Cloudbyz solutions and stay 21 CFR Part 11 compliant.
Fundamentals of an Audit Trail
The fundamental elements of an audit trail encompass a chronological account of system activities, encompassing details of the performer, action, timing, and rationale behind each action. By offering a comprehensive view of system actions, including the creation, modification, and removal of electronic records, an audit trail aids in identifying possible concerns and conducting incident investigations effectively.
Significance of an Audit Trail
Maintaining an audit trail holds significant significance in industries with strict regulations, notably in sectors like healthcare and life sciences. This practice is crucial for instilling confidence in data reliability and upholding the authenticity of digital records.
Furthermore, audit trails play a pivotal role in meeting regulatory obligations. For instance, the FDA's 21 CFR Part 11 directive, which specifically addresses electronic records and signatures, mandates that entities uphold precise and comprehensive logs of all electronic actions, encompassing modifications, removals, and additions to digital records. Beyond adherence to regulations, an audit trail serves as a tool for organizations to pinpoint and rectify instances of security breaches and fraudulent behavior.
Requirements outlined in 21 CFR Part 11
In accordance with FDA regulations, companies must store all their documentation in electronic form. If a business opts for a closed record-keeping system, it must comply with the stipulations detailed in 21 CFR Part 11.10. Specifically, for businesses utilizing a closed system, it's imperative to establish protocols and measures that ensure the authenticity, integrity, and confidentiality of electronic records.
Comprehensive Field Audit Trail Capability through Cloudbyz and Salesforce
Within the Cloudbyz eClinical platform, an enhanced field audit trail feature is available, empowering our customers to trace and monitor all operations conducted within the system. The Salesforce Field Audit Trail finds application across all Cloudbyz products- CTMS, eTMF, EDC and Safety & PV, ensuring alignment with 21 CFR Part 11 and additional compliance prerequisites concerning electronic signatures and record procedures. With Field Audit Trail, you can track up to 60 fields per object and archive field history data until it is ready for manual deletion.
Enabling eSignatures through Cloudbyz and Salesforce
With Cloudbyz Electronic Signature configurations, your organization can be confident in its safeguarding measures, ensuring complete adherence to regulatory mandates such as 21 CFR Part 11. The incorporation of eSignatures can be seamlessly implemented across all Cloudbyz products.
