Scientific irreproducibility thrives in the gap between physical sensor capture and report publication. Inquestra cryptographically binds hardware telemetry, notebook protocol logs, and reagent deductions into a deterministic SHA-256 digest adhering strictly to FDA 21 CFR Part 11.
When an experiment is concluded, Inquestra does not just save a database row. It compiles the entire context into an unalterable cryptographic block.
Raw serial byte arrays and microsecond timestamps are frozen in the Web Worker memory ring.
Experimental observations, math formulas, chemical lot numbers, and author metadata are normalized to JSON.
A deterministic SHA-256 hash is computed across all concatenated streams, creating a unique digital fingerprint.
The trial transitions to COMPLETED. Any subsequent modification attempt triggers an integrity alarm and invalidates the seal.
Designed specifically for Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) biotechnology compliance.
| CFR § Clause | Regulatory Requirement | Inquestra Architectural Implementation | Validation Status |
|---|---|---|---|
| § 11.10 (a) | Validation of Closed Systems | Deterministic state machine validation, automated end-to-end integration test suites | VALIDATED |
| § 11.10 (e) | Time-Stamped Audit Trails | Computer-generated, append-only PostgreSQL audit ledger logging actor, timestamp, action & hash | VALIDATED |
| § 11.50 | Signature Manifestations | Contains printed name, UTC timestamp, and explicit signing reason (Author, Reviewer, Principal Investigator) | VALIDATED |
| § 11.70 | Signature Linking | Cryptographic signature is inextricably hashed into the trial record block; cannot be excised or transferred | VALIDATED |
| NIH FAIR | Data Stewardship Standards | Standardized JSON-LD metadata schemas for Findability, Accessibility, Interoperability, and Reusability | COMPLIANT |
When you export an Inquestra experiment, you receive a standalone archive containing the raw CSV telemetry, the markdown protocol note, the author cryptographic manifest, and a checksum file.
Any regulatory inspector, peer-review journal, or institutional archivist can verify integrity without an Inquestra account using standard open-source command line utilities.
Explore the technical pipeline behind our high-speed acquisition and tamper-evident storage architecture.