The "Virtual Backroom" Engine

We don't just coach; we equip you. QMS.Coach provides access to our proprietary KoalaT.ai technology stack, designed to automate the low-value administrative work of compliance so you can focus on product safety.

What the Engine Does:

• The "Internal AI Auditor": Upload your SOPs, and our engine scans them against 21 CFR 820 and ISO 13485 to instantly flag gaps.
• Citation Management: Automatically links your internal procedures to the specific regulatory clauses they satisfy.
• Audit Simulation: An interactive chatbot that grills your SMEs with "FDA-style" questions to prep them for the real thing.
• Gap Analysis: Instantly generates a "Red/Yellow/Green" readiness scorecard for the QMSR transition.

Note: Our tools are "Advise Only." They support your decision-making but do not replace human validation.

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