At Vast Edge, compliance with regulatory standards like FDA Title 21 CFR Part 11 is a cornerstone of our operations. We understand the critical importance of maintaining the integrity, quality, and compliance of electronic records and electronic signatures in the life sciences sector. Here is how Vast Edge ensures full adherence to CFR 21 Part 11.
Comprehensive Compliance Checklist
We utilize the 21 CFR Part 11 compliance checklist as a guiding tool to evaluate and maintain compliance across all aspects of our electronic systems. This checklist includes an exhaustive set of questions that help us assess the compliance levels of electronic records and electronic signature systems, ensuring no detail is overlooked.
Validation
Vast Edge ensures all electronic systems are validated to perform their intended functions accurately, reliably, and consistently. We adhere to strict protocols to test and document the performance of these systems to meet compliance requirements.
Audit Trail
Our systems maintain a secure, time-stamped audit trail for all electronic records. This ensures transparency and traceability of data, allowing for easy tracking of modifications or updates.
System Integrity
We implement robust processes to maintain system integrity, ensuring that electronic records are protected against unauthorized access, alteration, or loss.
Copies of Records
Vast Edge ensures that copies of records are readily available in both human-readable and electronic formats, complying with FDA requirements for accessibility and reproducibility.
Record Retention
Our data management practices ensure long-term retention of records as per regulatory requirements, enabling seamless retrieval whenever necessary.
Electronic Signatures
Vast Edge employs secure and compliant electronic signature systems. These systems are uniquely assigned, ensuring authentication and accountability for each signature.
Access Security
We implement robust access control measures to ensure only authorized personnel can access critical systems and records. This minimizes the risk of unauthorized access and data breaches.
By embedding each requirement of FDA 21 CFR Part 11 into our operations, Vast Edge supports life sciences organizations in achieving full regulatory compliance. Our expertise and commitment to quality ensure that our clients’ electronic records and signature systems meet the highest standards of integrity and reliability.
For the full checklist, please click on CFR11compliancechecklist
Explore how Vast Edge can help you streamline your compliance processes while ensuring the utmost data security and operational efficiency. Contact us to know more!
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