Making it as simple as possible- that is our approach to regulatory compliance with TrakSYS, as an integral part of digitizing manufacturing operations. TrakSYS makes it as simple as possible to meet 21 CFR Part 11, Part 820, GMP, ISO 13485, European Annex 11, and ISO 9001 standards. User defined rules enforce validated workflows and automate data collection throughout the production process. Real-time notifications of non-conformances and defined responsibilities along with detailed and contextualized corrective actions provide comprehensive audit trail and transparency. Digitally enforce procedures; record, track, and trace the genealogy of raw materials; enforce Quality-by-Design principles; leverage the accurate and timely data to respond to production variances; and maintain records for meeting both in-house and regulatory compliance requirements. TrakSYS- empowering your digital transformation.