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Enterprise Power. Validated Infrastructure. No "SaaS Tax."
The ARC™ Framework leverages the Atlassian Marketplace to provide enterprise-grade functionality without the proprietary "black box" limitations of traditional eQMS vendors. We have curated a "Core Stack" of best-of-breed extensions, pre-validated and integrated into the framework to ensure you meet global regulatory standards from day one.
The Core Stack (The Necessities)
The Core Stack (The Necessities)
These tools are essential for meeting 21 CFR Part 11 and ISO 13485 requirements. They form the foundation of the ARC™ Assurance Baseline.
The Facilitators (Engineering Efficiency)
The Facilitators (Engineering Efficiency)
These tools "grease the wheels" of the QMS, ensuring that compliance doesn't slow down your development velocity.
Flexibility & Choice
Flexibility & Choice
We provide the "Best-of-Breed" recommendation, but you retain the freedom to adapt the system to your specific needs.
Risk Management Options: The ARC™ Framework includes a robust, native Risk and Threat management module built directly into Jira. However, for teams that prefer a specialized interface, the framework is fully compatible with SoftComply Risk Manager.
No Vendor Lock-In: Unlike proprietary eQMS vendors, we don't force you into a single ecosystem. You own the instance, and you have the freedom to choose the tools that best fit your engineering culture.
The SOUP Validation Strategy
The SOUP Validation Strategy
Managing "Software of Unknown Provenance" (SOUP) is a major regulatory hurdle. We’ve already done the heavy lifting.
Pre-Validated Baseline: Every app in our Core Stack has been vetted against the ARC™ Assurance Baseline.
SOUP Records Included: We provide the initial SOUP Evaluation and Risk Assessment for these preferred providers as part of your deployment, significantly reducing your validation burden.
App Governance: We leverage Atlassian’s Cloud Fortified and App Security programs to ensure your ecosystem meets the highest standards of reliability and security.
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