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DeepVault v1.0 Core
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Engineered for eLabFTW, REDCap & Custom Health Stacks

Pass your FDA & HIPAA audit without the $50k/year SaaS tax.

A lightweight, memory-safe cryptographic sidecar that adds FDA 21 CFR Part 11 digital signatures, Merkle-chained audit trails, and automatic storage drift detection to your open-source research stack.

Get 2-Page Qualification Brief View Architecture
FDA 21 CFR PART 11
HIPAA SECURITY RULE
ALCOA+ DATA INTEGRITY
GAMP 5 CATEGORY 4

The Regulatory Trap

The Biotech "Compliance Cliff"

01

Open Source Hit a Wall

Tools like eLabFTW or REDCap are great for early R&D. But standard relational databases can't prove to FDA inspectors that a DBA didn't modify historical data.

02

The Enterprise SaaS Tax

Proprietary platforms (Benchling, Dotmatics) demand $1,500–$5,000 per user, per year with multi-year minimum contracts, locking your intellectual property into their silo.

03

The DeepVault Solution

Keep your open-source tools. DeepVault sits as a microservice gateway in Docker, managing your storage with cryptographic immutability and instant FDA certificate generation.

Zero-Trust Architecture

How DeepVault Secures Your Data

01.

Bring Your Own Storage (BYOS)

Raw files never touch our servers or an external vendor. The browser streams directly to your private AWS S3 or MinIO bucket via short-lived pre-signed URLs. Complete data sovereignty.

02.

Merkle-Chained Synchronous Audit Ledger

Every read, write, upload, and signature generates a SHA-256 hash mathematically linked to the record before it. Access is denied if the ledger write fails. If a single row is modified by an attacker, the chain mathematically breaks.

03.

Sentinel Storage Drift Detector

A background daemon continuously audits S3 object baselines. If an AWS administrator or rogue process modifies a file out-of-band in storage, DeepVault locks the file, flags it as COMPROMISED, and sounds an alarm.

04.

21 CFR Part 11 Verification Certificates

Multi-factor e-signatures bind meaning, actor identity, and payload hashes. Export standalone, digitally-sealed Verification Certificates with one click to hand directly to FDA inspectors.

Download the Qualification Brief & Join the Pilot

Get our 2-page regulatory crosswalk mapping DeepVault to FDA Part 11 and HIPAA controls, plus access to our Docker sandbox.

No credit card required. Free Docker sandbox available for qualification testing.