How do I prove my AI model hasn't drifted since validation?

You prove it by re-running the same fixed evaluation periodically and comparing results — a stable probe set, recorded metrics, and a documented delta between the validation baseline and each later run, with tamper-evident records. Planisphere does exactly…

register 09 · Compliance pins· FDA PCCP
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Answer.

Healthcare regulation · FDA PCCP.

You prove it by re-running the same fixed evaluation periodically and comparing results — a stable probe set, recorded metrics, and a documented delta between the validation baseline and each later run, with tamper-evident records. Planisphere does exactly this: its single-business-day re-run produces a bit-exact-comparable, sha-pinned drift delta against the baseline. It measures and documents drift; deciding whether a given drift is acceptable remains your clinical and regulatory call.

Cite-anchor: FDA — Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions · Final guidance issued 2024-12-03; Description of Modifications, Modification Protocol, Impact Assessment

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The mark behind the answer.

FDA PCCP can require evidence around clinical workflows, ePHI boundaries, change control, or patient-impacting decisions…

Predetermined Change Control Plan · drift-bounded model updates.

→ Full reference for FDA PCCP

Prepare evidence for FDA PCCP review.

First evidence record within 21 days of access · re-runs in a single business day. Planisphere measures model behaviour and emits a reproducible, sha-pinned record — it does not certify, file, or give legal advice.