Traditionally, answering these questions requires explanations, screenshots, and reliance on internal audit logs.

TestLedger eliminates reliance on narrative explanations during inspection, reducing pressure on staff and minimizing audit-day uncertainty.

Compliance Impact (Anonymized)

A regulated testing program used TestLedger to support a routine inspection, enabling retrieval of complete, immutable records in minutes and eliminating follow-up documentation requests related to data integrity and chain-of-custody.

The TestLedger System of Record

TestLedger™ Compliance Platform is a documentation system designed to preserve the integrity of regulated test records when they are examined, challenged, or independently reviewed.

The platform captures test activity, operator actions, timestamps, and supporting evidence into a single record that is intentionally finalized and cryptographically sealed. Once sealed, the record becomes tamper-evident and independently verifiable, without reliance on internal explanations, screenshots, or reconstructed logs.

TestLedger does not interpret results, make regulatory determinations, or replace a Quality Management System. Its role is to ensure records are complete, traceable, and defensible during inspection or audit.

TestLedger supports compliance teams by ensuring records are complete, traceable, and reviewable before, during, and after inspection. Procedural compliance, approvals, and regulatory submissions remain the responsibility of the organization. Records remain accessible to the organization and can be reviewed internally prior to, during, and after inspection.

TestLedger is designed to reduce audit preparation risk without altering existing testing procedures or regulatory workflows.

Built for teams accountable for regulated testing, audit readiness, and record integrity. Applicable to CLIA, DOT, and other regulated testing programs.

A single, sealed record designed to withstand independent review.

How TestLedger Preserves Record Integrity

TestLedger enforces record integrity through system-controlled mechanisms that remove reliance on manual processes, post hoc explanations, or internal assurances.

Each record is finalized and cryptographically sealed using SHA-256 at completion. Any subsequent modification invalidates the seal and is detectable during inspection.

Supporting evidence, including photos and documents, is incorporated directly into the sealed record structure. System-generated timestamps and verified operator identification establish a defensible chain of custody from creation through retention.

All actions related to a record are logged and preserved, creating a complete audit trail that remains verifiable over time without reconstruction.

If a record is challenged during an inspection, TestLedger provides cryptographic proof of when the data was created, who accessed it, and whether it has been altered—without relying on narrative explanations or reconstructed evidence.

Integrity Mechanisms

CLIA Lab Directors

Managing inspection readiness and maintaining compliant documentation practices

IVD QA/RA Leaders

Building DHF/DHR documentation and preparing for FDA submissions

Contract Testing Services

Managing compliance documentation across multi-client regulated testing workflows

Early-Stage Dx Companies

Preparing for first FDA inspection with audit-ready infrastructure from day one

Increasing Focus on Record Integrity

FDA enforcement actions continue to cite recordkeeping and data integrity deficiencies as recurring drivers of compliance escalation

Expanded Traceability Requirements

Point-of-care and decentralized testing increases the need for end-to-end traceability across operator, device, and result

Risk-Based Oversight

Oversight can intensify rapidly after findings, complaints, or repeat observations—reducing margin for reactive cleanup

Generic Tools Create Compliance Drag

General-purpose document tools often require extensive validation to meet regulated expectations for integrity and retrieval

Failed or Delayed Submissions

Multi-Million Dollar Impact

Regulatory setbacks frequently drive significant costs through extended burn, additional studies, remediation activities, and delayed commercialization. Documentation deficiencies remain among the most common—and preventable—contributors.

Form 483 / Warning Letter

Months to Years

Remediation commonly spans several months to more than a year, particularly when record integrity, traceability, or systemic documentation controls are implicated—often requiring follow-up inspections and sustained FDA engagement.

Valuation & Financing

Material Pressure

Regulatory setbacks routinely exert material pressure on valuation, investor confidence, and transaction terms—especially for single-asset or pre-revenue companies where regulatory milestones drive financing events.

EDC platforms capture structured clinical trial data. TestLedger supports tamper-evident source documentation for point-of-care and decentralized testing activities that feed into, validate, or complement EDC workflows.

LIMS platforms manage centralized laboratory operations, samples, and workflows. TestLedger extends documentation integrity to decentralized, field-based, and point-of-care testing environments where traditional LIMS coverage is limited.

QMS platforms define procedures, controls, and quality expectations. TestLedger provides the evidence layer that demonstrates those procedures were executed as defined, producing records suitable for internal audits, notified bodies, and regulatory inspections.

Why Not SharePoint, Google Drive, or Paper Logs?