Improving Compliance through Digitalisation
CXV Global SmartFactoryTM is designed to continuously meet the needs of cGxP in diverse global regulatory markets. It ensures traceability across all batches, recipes, and SKUs.
Meeting the requirements of 21 CFR Part 11/Annex 11 and built to GAMP 5 principles, the system adheres to the highest standards of data integrity and user access management. It offers bespoke role level access and group integration with Active Directory.
The system provides a suite of compliance reports ensuring system controls and audit logs provide process transparency and make certain that errors, deviations and CAPAs are avoided. The system also comes with a standard set of validation documentation (FDS, SDS, IQ/OQ), ensuring a fast and robust validation process.
As the market becomes more diverse, more complex and even more demanding, SmartFactoryTM introduces a level of connectivity, flexibility and simplicity making your manufacturing factories increasingly agile, efficient and competitive.