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Platform · BioAudit

BioAudit

Experimental prototype

Tamper-evident evidence ledger

Experimental tamper-evident evidence ledger for regulated environments. Hash-chained events, write-once storage, and a roadmap to offline-verifiable audit packs.

Built for teams navigating FDA, GLP, and GxP requirements who need cryptographic assurance that history cannot be silently rewritten.

View pricing about audit readinessSee trust center

Status: experimental prototype. Not yet intended for production compliance use without additional review.

Every event includes the digest of the previous event, forming an unbroken chain.

hash_chain.json
json
[
  {
    "seq": 1,
    "event": "study_created",
    "payload_digest": "sha256:a1b2...",
    "prev_digest": "sha256:0000..."
  },
  {
    "seq": 2,
    "event": "sample_received",
    "payload_digest": "sha256:c3d4...",
    "prev_digest": "sha256:a1b2..."
  },
  {
    "seq": 3,
    "event": "protocol_deviation",
    "payload_digest": "sha256:e5f6...",
    "prev_digest": "sha256:c3d4..."
  }
]
SHA-256Hash chainWORM storageEvidence pack
Evidence
Every record is linked cryptographically. Tampering with any event invalidates the entire chain.
VerifiedExamine proof bundle
Event integrity
SHA-256 linked sequence
Hash-chained
Each event includes the digest of the previous event so tampering breaks the chain.
Storage model
Write-once read-many
WORM
Targets append-only storage so historical records cannot be retroactively modified.
Export format
zip + manifest + digest
Evidence pack
Planned offline pack for auditors with a single root digest to verify.
Status
Experimental
Prototype
Not yet intended for production compliance without additional review.

Built for teams that require proof

BioAudit applies ideas from formal verification to regulated life-science environments. The goal is simple: if history is altered, it should be obvious.

Hash-chained events
  • Every lab event, protocol action, and compliance checkpoint is ingested into a unified audit bus.
  • Each record contains the SHA-256 digest of the previous record, forming a tamper-evident sequence.
Write-once storage
  • Uses WORM semantics so that once an event is written, it cannot be altered or deleted.
  • Prevents retroactive tampering even by administrators with full system access.
Offline evidence packs
  • Roadmap includes exporting a zip archive containing all events, a canonical manifest, and a root digest.
  • Third-party auditors can verify pack integrity without access to the live system.
Build toward audit-ready infrastructure
If you are navigating FDA, GLP, or GxP requirements, we would love to hear what you need and how BioAudit can fit into your evidence stack.
View pricing See trust center

Part of the Omnis platform

BioAudit is part of our longer-term vision for deterministic, inspectable systems. It shares design principles with BioFlow and BioCost: canonical outputs, verifiable hashes, and replayable artifacts.

BioFlow

Deterministic workflow OS with verifiable artifacts and cryptographic audit trails.

View BioFlow
BioCost

Nextflow cost analyzer with deterministic reports and replayable configuration patches.

View BioCost

Use cases

Built for regulated environments where audit trails are not optional and trust must be verifiable.

FDA-regulated labs

Build toward 21 CFR Part 11 readiness with timestamped, hash-chained records of every protocol deviation.

Explore FDA-regulated labs →
GLP/GxP environments

Maintain an immutable audit trail for study conduct, sample handling, and analytical procedures.

Explore GLP/GxP environments →
Multi-site clinical trials

Collect tamper-evident event streams from distributed sites and verify them against a shared root digest.

Explore Multi-site clinical trials →

Developer corner

BioAudit is a Python/FastAPI prototype with Alembic migrations and a local WORM storage layer. It is designed to run locally first, with a clear path toward hosted and air-gapped deployments.

Trust CenterVeriBiotaBioFlowGitHub
Python / FastAPI
POST /audit/events
{
  "event_type": "sample_received",
  "study_id": "STU-001",
  "payload": { "sample_id": "S-1001" }
}
Appends the event to the hash chain and returns the sequence number and event digest.

Build toward audit-ready infrastructure

BioAudit is part of our longer-term vision for deterministic, inspectable systems. If you are navigating FDA, GLP, or GxP requirements, we would love to hear what you need.

Book a 15-min introSee VeriBiotaSee trust center