FDA 21 CFR Part 11 Solution
SoftExpert offers the most advanced and comprehensive software solution for compliance management, that meets the demanding needs of various global regulations. SoftExpert Excellence Suite helps companies to comply with FDA 21 CFR Part 11, while lowering the costs, maximizing success, increasing productivity and reducing risks.
The SoftExpert solution enables organizations to easily meet FDA 21 CFR Part 11 requirements, providing resources to manage records, documents, reviews, access controls, and also trainings, non-conformances, KPIs, processes and others, boosting organizational efficiency, reducing rework and waste. With online collaboration capabilities, the organization and managers can communicate and be updated about the compliance initiatives, involving more users, teams, offices and business units with a systematic and unified approach that keeps the company ready for the FDA audits.