The ARC™ Framework electronic Quality Management System (eQMS) is engineered as a Closed System to ensure the highest levels of data integrity, security, and regulatory alignment. 

By leveraging Atlassian’s enterprise-grade cloud infrastructure alongside specialized compliance integrations like eSign Document Management, the framework provides a validated environment for managing medical device lifecycles. Our architecture is grounded in a STRIDE-based threat model and is fully aligned with 21 CFR Part 11 and ISO 13485:2016 requirements, ensuring that all electronic records and signatures are trustworthy, reliable, and legally binding.