Learn how InferTrust™ creates tamper-evident records for every AI model update, retraining event, and threshold adjustment to support FDA PCCP compliance.
Predetermined Change Control Plans (PCCPs) allow AI medical device manufacturers to update their algorithms within pre-approved boundaries without filing a new regulatory submission for each change. InferTrust™ FDA Enforcement (Patent Pending) creates the evidentiary infrastructure that PCCP compliance demands.
Every time an AI model is updated, retrained, or reconfigured, InferTrust™ seals a change record containing the previous model version hash and the new model version hash, the training data fingerprint for the new version, the validation test results and acceptance criteria outcomes, the timestamp of the change event, and the policy version that authorized the change. These records form a tamper-evident chain that documents the complete history of algorithm evolution. FDA inspectors can verify that every change followed the PCCP protocol by examining the sealed record chain.
If a model update produces validation results that fall outside the PCCP acceptance criteria, InferTrust™ records that outcome as a sealed nonconformance event. The record documents which criteria were not met, what corrective action was taken (rollback, additional training, threshold adjustment), and the subsequent validation results. This creates a verifiable quality record that satisfies both PCCP requirements and Part 820 corrective action documentation.
When FDA inspects a manufacturer's PCCP adherence, investigators review the change history, validation records, and performance data. InferTrust™ provides all of this in a single, cryptographically verified chain. Investigators do not need to cross-reference multiple systems or rely on organizational assertions about record integrity. The cryptographic guarantees provide the verification directly.