Medical Devices
FDA 21 CFR Part 820 Evidence Review
Map device manufacturer and supplier documentation against Quality System Regulation requirements. Identify what is well covered, partially covered, or not covered before audit preparation.
01 — Operational Trigger
Preparing for FDA Quality System inspection or supplier qualification audit
Quality assurance and regulatory affairs teams must demonstrate documented compliance with FDA 21 CFR Part 820 Quality System Regulations. Whether preparing for an FDA inspection, conducting a supplier qualification review, or maintaining ongoing audit readiness, teams need a structured view of what is well covered, where gaps exist, and what requires immediate attention.
02 — Why Manual Review Slows Decisions
QSR controls span a large, complex document set
Part 820 compliance requires evidence across design controls, production controls, corrective and preventive action, complaint handling, purchasing controls, and more. Documentation is typically distributed across SOPs, work instructions, device history records, supplier agreements, and internal audit reports. Manually mapping this volume to specific QSR subparts is time-consuming and prone to coverage gaps that only surface during inspection.
03 — Workflow Complexity
Supplier qualification adds a second documentation layer
Beyond internal documentation, Part 820 requires documented supplier controls under §820.50. Teams must review supplier quality agreements, audit reports, certificates of conformance, and corrective action histories — then map that evidence to purchasing controls requirements. Managing internal and supplier documentation within the same review workflow creates version control and traceability challenges without a structured approach.
04 — How Tiebreaker AI Structures Evidence
Structured mapping to QSR subparts
Upload device documentation — SOPs, device history records, supplier quality agreements, audit reports, CAPA records — and select FDA 21 CFR Part 820 as the framework. Tiebreaker AI maps evidence to QSR subpart controls and surfaces what is well covered, partially covered, or not covered. Each project is scoped to a defined manufacturer or supplier context, keeping review boundaries clean and traceable.
05 — What Teams Can See Faster
Control-level readiness view before audit preparation begins
Teams can identify which QSR subparts have adequate documentation, which require additional evidence, and which represent inspection risk — before entering formal audit preparation. This allows QA teams to prioritize remediation, assign follow-up, and approach supplier qualification with documented traceability.
06 — Expected Operational Outcome
Reduced inspection risk through structured pre-audit review
Teams using a structured evidence review workflow can identify and close documentation gaps earlier in the audit cycle. The result is a more defensible readiness position, reduced inspector findings related to documentation gaps, and a repeatable supplier qualification process that scales with the supplier base.
Ready to structure your FDA 820 evidence review?
Select FDA 21 CFR Part 820, review the sample project, or upload a redacted document set to explore the workflow.