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.

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