FDA FSMA 204 & FSVP GUIDE
Organize supplier verification evidence for FDA FSMA compliance
A practical digital record-keeping pipeline for food safety teams managing Foreign Supplier Verification Programs (FSVP) and FSMA Rule 204 Traceability Lot Codes.
How the Continuous Evidence Loop Operates
1
Identify supplier regulatory roles (Domestic Processor, Foreign Importer, Co-Packer).
2
Link required verification activities (hazard analysis, annual audits, testing) to evidence slots.
3
Collect and verify certificates of analysis (COAs) and third-party audit reports.
4
Assign PCQI review ownership and log verification timestamps.
5
Retain compliance records in encrypted storage to meet 2-year statutory retention.
CORE PLATFORM ARCHITECTURE
What Evidlane Records & Enforces
Evidlane manages supplier scopes, requirement coverage, immutable file versions in Cloudflare R2, certificate health states, 30/14/7-day reminder delivery logs, human QA approval signatures, rejection reasons, and append-only audit events. It does not replace human QA judgment or make automated legal compliance claims.
✓ Cloudflare R2 AES-256 Vault✓ ClamAV Antivirus Quarantine✓ Single-Use 7-Day Vendor Tokens✓ 1-Click ZIP Audit Packets
Frequently Asked Questions
Is Evidlane an automated FSVP compliance decider?
No. Evidlane organizes your verification records and reminders. Your Qualified Individual (QI/PCQI) conducts the verification evaluation.
Educational content only. Not legal or regulatory advice.
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