Why CERDAAC
Validation
Exceeding Quality and Compliance Standards
Pre-validated to meet the stringent requirements of 21 CFR Part 11
21 CFR Part 11 is a section of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures. Software validation under 21 CFR Part 11 is crucial for ensuring that digital systems are compliant with FDA standards and that they maintain the integrity, confidentiality, and accuracy of electronic data.
Reducing Validation Time and Effort
Pre-validated software comes with evidence that it has already undergone rigorous testing and documentation to ensure compliance with FDA regulations. This means that manufacturers can save substantial resources and time that would otherwise be spent on conducting extensive validation tests themselves. The cost savings can be significant, considering the complexity and duration of validating software from scratch.
Validation
Streamlined and Comprehensive
Quicker Implementation: Since the software is already validated to meet regulatory standards, manufacturers can implement it more quickly. This speed in deployment allows organizations to start using the software for actual operations sooner, accelerating the time to market for products and enabling quicker returns on investment.
Reduced Risk of Non-Compliance: Using pre-validated software reduces the risk of regulatory non- compliance. Manufacturers can be more confident that their electronic records and signatures meet FDA standards, which helps avoid potential legal and financial penalties associated with non-compliance.
Enhanced Data Integrity and Security
Pre-validated software is designed to ensure high levels of data integrity and security, which are crucial for meeting Part 11 requirements. Manufacturers benefit from built-in features like audit trails, access controls, and data encryption, which safeguard sensitive information and ensure it remains unaltered and traceable.
We've had real success with our audits since switching to this platform. It's not just a great tool; it's a game-changer for industry compliance.
Leading pharmaceutical company
IOQ, Traceability, and Summary Report
We also include in our validation – Installation/Operational Qualification Protocol (IOQ) – Step-by-step instructions are provided to verify both installation and operation of the software after SDS approval, traceability matrix document which maps out and verifies that all requirements in the FRS are accurately described in the SDS and tested during the IOQ. Finally, a Validation Summary Report (VSR) – that documents the execution results of the IOQ, affirming the software’s performance aligns with its intended use as outlined in the FRS and SDS.
Start Your Validation Journey Now
Experience the difference that validation makes. For comprehensive validation trust the expertise of CERDAAC. Join the ranks of satisfied customers who rely on CERDAAC.