Today’s regulated environments demand better quality and compliance processes. For those in manufacturing regulated by FDA, it is crucial to have systems that assure stringent compliance with government and industry standards. As well as extensibility to comply with future requirements. TrakSYS is a unified Manufacturing Operations Management (MOM) system that helps manufacturers meet an assortment of regulatory requirements and standards including FDA’s 21 CFR Part 11, GMP, ISO 13485, European Annex 11, and ISO 9001.
TrakSYS automates Traceability and stores all necessary documents in a centralized, web-based location so every stakeholder involved in your process can find the most up-to-date documents in one place. You can ensure that stringent controls are in place to introduce changes to the system as well as manage development, testing, and production take place in dedicated environments. All configuration changes, actions, recorded value adjustments, and digital signatures are logged for the creation of a comprehensive audit trail.
Please join us for an informative webinar to see how TrakSYS Manufacturing Operations Management software platform allows you to meet and demonstrate regulatory compliance.