Manual Transcription Errors
Data moves from instrument to LIMS via manual entry or fragile CSV exports. Errors propagate. Values change. The chain of custody breaks before it begins.
Open Alpha · v0.1 · Onboarding lab partners
Laboratory Data That Cannot Be Altered
Cryptographically signed at the instrument. Immutable audit trails that satisfy 21 CFR Part 11 and ISO 17025.
Immutable QC captures measurements directly from analytical instruments—HPLC, mass spectrometry, discrete analyzers, flow injection systems, and environmental sensors. Each data point is cryptographically signed at the source and written to an immutable audit trail. No manual transcription. No post-hoc manipulation. Mathematical proof of integrity from instrument to regulator.
- Live Web app, signing, and hash-chained ledger
- Live Public cryptographic registry
- In progress Direct instrument capture (HPLC, MS)
- Planned External auditor verification portal
The Problem
Laboratory Data Is Vulnerable at Every Step
Undetectable Tampering
Without cryptographic verification, altered records are indistinguishable from authentic ones. Auditors must trust process. They cannot verify integrity mathematically.
Compliance Overhead
21 CFR Part 11 and ALCOA+ requirements demand complete, consistent, enduring records. Traditional systems generate paper trails, not mathematical proofs.
FDA Warning Letters from 2023 to 2024 show data integrity violations as the leading cause of regulatory action against analytical laboratories.
The Solution
Cryptographic Signing at the Source
IQC sits between your instruments and your data systems. It captures measurements the moment they are generated—before human hands touch them—and commits them to a tamper-evident audit trail.
Instrument-Grade Provenance
Every measurement is signed at the instrument using ECDSA. The signature, timestamp, and instrument metadata form an unalterable chain of custody from capture to audit.
Zero Manual Transcription
Direct instrument integration eliminates the gap between measurement and record. No CSV exports. No copy-paste errors. No opportunity for manipulation.
Mathematical Audit Trails
Regulators verify integrity via cryptographic proof, not just process documentation. Tamper-evident records provide third-party verifiable evidence that data has not changed since capture.
How It Works
From Instrument to Immutable Record
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01
Connect
HPLC, mass spectrometers, pH meters, and environmental sensors connect via standardized protocols (RS-232, TCP/IP, file watchers).
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02
Capture
Raw measurement data is intercepted at the point of generation, before it reaches any editable system. Calibration metadata is captured simultaneously.
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03
Sign & Commit
IQC applies ECDSA signatures to each measurement and appends it to a local tamper-evident database. Periodic cryptographic commitments are published to a public registry for independent verification.
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04
Verify
Auditors verify data integrity via public attestation records. Cryptographic proofs confirm data has not been altered since capture—without exposing proprietary methods or raw results.
Technical Implementation
Built on Proven Cryptographic Standards
IQC implements established cryptographic attestation patterns from supply chain security and distributed systems research, adapted for laboratory compliance requirements.
Research Foundation
Sigstore
Certificate transparency and keyless signing infrastructure. IQC adapts Sigstore patterns for short-lived signing keys and transparent attestation logs.
sigstore.dev →OpenTimestamps
Distributed timestamping for proof of existence. IQC uses decentralized anchoring for third-party verifiable timestamps without registry bloat.
opentimestamps.org →CLSI AUTO-10A
Automated verification standards for clinical laboratories. IQC aligns with CLSI AUTO-10A guidelines for automated result verification and exception handling.
clsi.org →Technology Stack
RustCore middleware for performance and memory safety
SQLiteLocal hash-chained ledger with SQL interface
ECDSA (secp256k1)Cryptographic signing at instrument level
SHA-256Merkle tree construction for tamper evidence
Public RegistryPeriodic cryptographic commitments for independent verification
OpenAPIRESTful integration with LIMS and ELN systems
Who It's For
Built for Regulatory-Intensive Labs
IQC is designed for labs that face intense regulatory scrutiny—pharmaceutical QC, environmental testing, clinical diagnostics, and food safety.
Pharmaceutical QC
Support for 21 CFR Part 11, Annex 11, and data integrity guidelines. Complete audit trails for method validation and batch release.
Environmental Monitoring
Continuous data capture from field sensors. Tamper-evident records for EPA and state regulatory submissions.
Contract Testing Labs
Demonstrate data integrity to clients without exposing proprietary methods. Cryptographic proof builds trust with sponsors.
Deploy Source-to-Ledger Integrity
IQC Alpha is open for early laboratory partners. We are onboarding analytical labs running HPLC, mass spectrometry, and environmental monitoring instrumentation. Contact us with your instrument list and compliance requirements.