We have moved from prescriptive, one-size-fits-all testing to a risk-proportionate assurance model. This approach satisfies ISO 13485:2016 §4.1.6 and the 2025 FDA CSA Guidance by focusing effort where the risk to patient safety and data integrity is highest.

• From CSV to CSA: We replace legacy DQ/IQ/OQ/PQ protocols for QMS software with integrated SDLC-based validation.

• Critical Thinking: We apply engineering judgment to determine the appropriate level of testing—scripted, unscripted, or exploratory—based on the system's risk profile.

• Proportionate Effort: Lower-risk administrative functions are assured through vendor assessment and intended-use rationales, while high-risk workflows (like ECNs and Electronic Signatures) receive rigorous scripted verification.

Every ARC™ deployment is supported by a suite of substantive, audit-ready documents that establish the system's validated baseline and ensure ongoing compliance. These records form the Medical Device File for the framework, demonstrating that it has been planned, designed, and verified in accordance with global standards.

Every ARC™ deployment is governed by a comprehensive Verification and Assurance Plan (VAP). This document defines how we establish and maintain objective evidence that your baseline is fit for its intended use.

• The Master Baseline: We maintain a master development instance where every release candidate is verified against our core requirements.

• Commissioning Verification: When we transfer the ARC™ baseline to your instance, we execute a targeted Commissioning Suite to confirm the system operates exactly as intended in your specific environment.

• The Evidence Vault: All verification records—test cases, executions, and traceability—are stored directly in your instance, providing an immediate, searchable audit trail.

The ARC™ Framework is built to satisfy the most stringent global regulatory requirements. Our assurance baseline is pre-mapped to:

• ISO 13485:2016 §4.1.6: Documented procedures for QMS software validation.

• FDA 21 CFR Part 11: Validated controls for electronic records and signatures.

• IEC 62304: Software lifecycle processes for medical device software.

• ISO 14971: Risk management integrated into the assurance lifecycle.

• QMSR (2026): Alignment with the FDA’s harmonized Quality Management System Regulation.

Validation is not a "one-and-done" event. As your business grows and your system evolves, the ARC™ Framework ensures you stay in a validated state through our Engineering Change Notice (ECN) model.

• Impact-Based Re-verification: Every change is assessed for its impact on the validated baseline.

• Regression Testing: We provide the roadmap for targeted regression testing, ensuring that updates to the Atlassian platform or Marketplace apps don't compromise your compliance.

• Self-Sufficiency: We provide the procedures and the training so your team can maintain the system's assurance status in-house, eliminating the need for expensive external re-validation projects.