TestLedger™ Compliance Platform replaces after-the-fact documentation with real-time, cryptographically sealed test records. Auditors get verifiable evidence, not explanations. TestLedger makes you audit-ready without the scramble.
Designed for teams accountable for regulated testing, audit readiness, and record integrity.
Prevention matters more than cleanup.
Applicable to CLIA, DOT, and other regulated testing programs.
Cryptographic Record Integrity
SHA-256 hashing applied at record finalization to create tamper-evident documentation with verifiable authenticity.
Complete Audit Trail
Full chain of custody capturing user actions, timestamps, and test events with immutable traceability.
Inspection-Ready Output
On-demand reports formatted for regulatory review, eliminating manual compilation and audit-day uncertainty.
Designed to Support
21 CFR Part 11
Electronic records and signatures
DOT Programs
Federally mandated testing
CLIA Standards
Regulated laboratories
HIPAA Safeguards
Protected health information
What Auditors Actually Examine
During inspections, audits, and formal reviews, regulators focus on a small set of verifiable facts. These questions determine whether records are trusted or subjected to deeper scrutiny.
When exactly was this data finalized?
Not when it was entered. Not when it was exported. When was it formally locked?
How do you know it was not modified later?
Can integrity be demonstrated, not just asserted?
How were corrections handled?
Is the correction history transparent and complete?
Can this be independently verified?
Or does verification rely on internal assurances?
Traditionally, answering these questions requires explanations, screenshots, and reliance on internal audit logs.
TestLedger removes interpretation from the audit process by making the record itself the answer.
During an FDA inspection, an auditor requests the full lineage of a diagnostic result generated 14 months prior, including who performed the test, when the record was finalized, whether any corrections were made, and proof that the data hasn't been altered since.
With TestLedger, the complete, time-stamped, cryptographically sealed record is retrieved in seconds, with no manual reconstruction, no explanations required.
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 is outcome-agnostic by design. It does not interpret results, make regulatory determinations, or replace existing quality systems. Its role is to ensure that records remain complete, traceable, and defensible whenever they are reviewed.
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.
Record Lifecycle
Draft
Editable
Finalized
Complete
Sealed
Tamper-evident
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 intentionally finalized and sealed using cryptographic hashing at the time of completion. Any subsequent modification invalidates the seal and is immediately detectable during review.
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.
Integrity Mechanisms
Document Any Regulated Test Result
From clinical rapid tests to industrial calibration verification, any test that requires defensible documentation can be recorded with cryptographic integrity.
Clinical Rapid Tests
Rapid and point-of-care testing requiring documented results for regulatory review.
Instrument Measurements
Digitally generated readings requiring traceable, auditable records.
Environmental Monitoring
Regulatory monitoring of water, air, and environmental samples.
Food Safety
Compliance documentation for pathogen detection, hygiene verification, and safety programs.
Veterinary Diagnostics
Diagnostic testing across companion animal, livestock, and veterinary programs.
Industrial Quality Control
Calibration verification, equipment status, and quality control documentation.
Where Documentation Integrity Matters Most
Designed for environments where records are routinely subject to regulatory, legal, and operational scrutiny.
Workplace Testing
Drug and alcohol programs
Clinical POC
CLIA-waived testing
Veterinary Clinics
In-house diagnostic testing
Water Utilities
Compliance testing
Food Production
HACCP documentation
Manufacturing
Quality control verification
Legal and Court
Defensible documentation
Government
Compliance programs
Capture. Record. Seal. Retain.
A structured documentation workflow designed for regulated environments.
Capture
Photo documentation captured at the point of testing
Record
Test details and results entered
Seal
System applies cryptographic seal
Retain
Record remains verifiable over time without reprocessing
The platform is designed to minimize documentation time without disrupting existing testing operations.
The Compliance Platform in Action
From tier selection to immutable sealed records, see the complete workflow.
TestLedger™
Create your account
14-day free trial, no credit card required
Tier Selection at Signup
Audit-Ready Dashboard with Seal Status & Witness Tracking
E-Signature & Witness Verification (21 CFR Part 11)
Sealed Record with Chain of Custody & Audit Timeline
These screenshots reflect capabilities of the TestLedger™ Compliance Platform.
Electronic signatures, witness verification, and audit timelines are core features in the Audit-Ready Tier.
All names, record IDs, and data shown are fictitious examples for illustration purposes only and do not represent actual records.
Measured Compliance Impact
TestLedger is designed to support measurable reductions in audit preparation time and documentation gaps across regulated testing programs. Actual outcomes depend on organizational implementation and existing processes.
Typical Operational Impact Across Regulated Workflows*
Reduction in audit preparation time by centralizing immutable test records, metadata, and supporting evidence
Fewer documentation discrepancies identified during internal audits due to standardized record capture and version control
Inspection readiness achieved, compared to multi week manual compilation cycles
Reduction in remediation effort following internal or external quality reviews
Reducing inspection related labor costs and operational disruption
*Based on projected operational improvements. Actual results depend on organizational implementation and existing processes.
Built Different
Most test documentation tools lock organizations into a single manufacturer's products. TestLedger works with the tests you already use.
Competitor Solutions
Manufacturer tied documentation tools
- ○ Only works with one brand's tests
- ○ Limited to a single testing category
- ○ Photos only, no document uploads
- ○ Contact sales for pricing
- ○ Switching costs lock you in
TestLedger™
Open platform
- ✓ Any test, any brand No lock in
- ✓ 8+ industries Healthcare to food safety
- ✓ Photos, PDFs, CSVs Any standard format
- ✓ Transparent pricing See plans below
- ✓ Cryptographic seal SHA-256 tamper evidence
Your tests. Your data. Your choice.
TestLedger is the documentation layer, not a sales funnel for someone else's consumables.
Built for Regulated Testing Professionals
TestLedger serves organizations where documentation integrity directly impacts regulatory standing, legal defensibility, and operational credibility.
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 multi-client compliance across diverse testing programs
Early-Stage Dx Companies
Preparing for first FDA inspection with audit-ready infrastructure from day one
Also serving: Compliance officers, testing program managers, occupational health services, and food safety operations
Audit, Inspection, and Regulatory Readiness
Operationally ready and regulator-aware documentation infrastructure.
Audit and Inspection Readiness
When inspections occur, documentation is immediately accessible and structured for review.
- ✓ Complete test history available on demand
- ✓ Filters by date, operator, test type, or result
- ✓ Exportable PDF reports for inspectors
- ✓ Verifiable record integrity indicators
- ✓ Chain of custody documentation
- ✓ Operator training and access records
No manual reconstruction required.
Instant Reports
Generate audit documentation in seconds, not hours
Security and Regulatory Alignment
Designed to support common documentation and control expectations across regulated programs, and map cleanly to existing SOPs and quality systems.
HIPAA Controls
Designed to support HIPAA compliance with role-based access, audit logs, and encryption capabilities
CLIA
Operator ID, timestamps, retention support, lot and device fields, review-friendly reporting
Electronic Records & Signatures
Implements audit trail patterns, access controls, and record integrity features aligned with 21 CFR Part 11 principles
DOT Workflows
Workflow standardization and chain-of-custody support fields. Note: Does not replace federally-mandated CCF forms where required
Regulatory Framework Alignment
TestLedger™ Compliance Platform is designed to support regulated testing programs operating under FDA, ISO, CLIA, and similar oversight frameworks. The platform maps to established documentation and traceability requirements, enabling continuous inspection readiness rather than episodic compliance efforts.
Feature-to-Clause Mapping
Precise alignment between TestLedger capabilities and specific regulatory requirements.
TestLedger supports these requirements through platform design, not post-hoc compliance retrofits.
TestLedger™ Compliance Platform does not replace quality systems or guarantee regulatory compliance. It reinforces existing systems by ensuring the records those systems depend on are complete, verifiable, and inspection ready at all times. Automation within TestLedger is intended to reduce manual error and improve consistency, not to remove accountability.
Regulatory frameworks are not optional. Infrastructure that supports them should not be either.
Why This Matters Now
The compliance documentation landscape is shifting rapidly. Organizations that invest in audit-ready infrastructure now will be better positioned as regulatory scrutiny intensifies.
Increasing FDA Scrutiny
Warning letters citing documentation deficiencies have increased significantly since 2020
Decentralized Testing Growth
Point-of-care and decentralized diagnostics require documentation that travels with the test
Rising Audit Frequency
Annual inspection cycles leave less time for reactive compliance preparation
Tool Inadequacy
Generic document tools lack immutability, traceability, and audit-specific workflows
Compliance Infrastructure, Not Compliance Theater
TestLedger creates defensible documentation that survives regulatory scrutiny, not just documentation that looks compliant until an auditor asks questions. When inspectors request evidence of record integrity, chain of custody, and tamper-proof timestamps, the answer should be the record itself.
The Cost of Documentation Failure
Audit deficiencies and failed FDA submissions don't just delay timelines. They can devastate companies. The question isn't whether audit-ready documentation is worth the investment. It's whether your organization can afford to be caught without it.
Failed FDA Submission
$2-10M+
Repeated studies, regulatory delays, and market access postponement. Documentation deficiencies are among the most common, and preventable, causes.
Form 483 / Warning Letter
6-18 mo
Remediation timelines, corrective action plans, and follow-up inspections. Record integrity issues trigger disproportionate scrutiny.
Valuation Impact
20-40%
Stock price decline or valuation haircut following regulatory setbacks. Investor confidence erodes faster than it builds.
Prevention Costs a Fraction of Remediation
TestLedger doesn't guarantee regulatory approval. No system can. But audit-ready documentation infrastructure eliminates one of the most common, most preventable failure modes. The cost of continuous compliance readiness is measured in hundreds per month. The cost of rebuilding documentation after a deficiency is measured in months of lost time and millions in delayed revenue.
Complements Your Existing Systems
TestLedger is documentation infrastructure, not a replacement for EDC, LIMS, or your Quality Management System. It makes those investments more successful by ensuring the records they depend on are audit-ready from the start.
EDC Systems
Electronic Data Capture
EDC captures clinical trial data. TestLedger provides the tamper-evident documentation layer for point-of-care testing records that feed into or complement EDC workflows.
✓ Enhances EDC data quality with audit-ready source documentation
LIMS
Laboratory Information Systems
LIMS manages lab operations and sample workflows. TestLedger extends documentation integrity to decentralized and point-of-care testing where LIMS coverage doesn't reach.
✓ Extends compliance coverage beyond centralized lab environments
QMS
Quality Management Systems
QMS defines procedures and controls. TestLedger provides the immutable record layer that demonstrates those procedures were followed: the evidence QMS audits require.
✓ Provides the documentation evidence your QMS depends on
Why Not SharePoint, Google Drive, or Paper Logs?
Generic file storage has no cryptographic sealing, no tamper evidence, no chain of custody
Paper logs can be lost, altered, backdated, or reconstructed. Auditors know this
Spreadsheets lack audit trails, can be edited invisibly, and fail inspection scrutiny
Pricing and Packaging
Choose the compliance level your organization needs. Advanced regulatory documentation fields available in Professional and above.
All plans are self-activated. No sales calls, approvals, or onboarding gates. Records are enforceable from first use.
Pricing reflects documentation risk exposure and regulatory scrutiny level, not test volume alone.
When in doubt, choose the highest level of scrutiny your records may face.
Starter
Best for internal or low-risk testing where basic documentation is sufficient
Core documentation for low-risk or internal testing programs
Up to 3 users · 500 records/mo
- Photo capture/photo upload
- SHA-256 cryptographic sealing
- Offline capture & cloud sync
- PDF & JSON export
- Core fields: Result, Subject ID, Lot#, Operator
- Notes/Comments (free text)
- Email support (48hr response)
- Image attachments only (up to 5MB)
14-day free trial · No credit card required
Professional
Best for regulated testing programs preparing for audits or inspections
Expanded regulatory documentation fields for regulated testing
Up to 10 users · 5,000 records/mo
- All Starter features, plus:
- PDF, Word, Excel & document attachments
- + FDA 21 CFR 820 Compliance Fields:
- Kit manufacturer & catalog #
- Kit expiration tracking
- Controls passed verification
- Specimen type & collection time
- Invalid reason documentation
- Administrative dashboard
- API access & multi-location
- Priority support
14-day free trial · No credit card required
Audit-Ready
Best for high-stakes testing where results may be challenged or disputed
Legal defensibility for high-stakes testing
Up to 50 users · 25,000 records/mo
- All Professional features, plus:
- + Advanced Audit Trail:
- Witness ID & dual verification
- Retest linking & traceability
- Temperature & UDI/GTIN tracking
- Batch compliance reporting
- SSO/SAML integration
- HIPAA BAA available where applicable
- 99.9% SLA · 7-year retention
14-day free trial · No credit card required
Start your trial for early access and exclusive launch pricing. Launching Q1 2026.
Core compliance features available at launch. Advanced capabilities will expand throughout Q1 2026.
Billing & Trial Terms
14-Day Free Trial
- No credit card required to start
- Full access to your selected tier features
- Add payment method anytime during trial
- Billing begins only after trial ends and payment method is on file
Subscription Terms
- Monthly or annual billing. Save 20% with annual
- Cancel anytime. No long-term commitment
- Automatic renewal until canceled
- Access continues through end of billing period after cancellation
By starting a trial, you agree to our Terms of Service and Privacy Policy, which include billing, renewal, and cancellation terms.
Plan Overview
- Non-regulated settings
- Small wellness programs
- Basic documentation needs
- CLIA-waived laboratories
- Clinical trials
- DOT drug testing programs
- Healthcare facilities
- DOT observed collections
- Results that may be disputed
- Healthcare contracts (need BAA)
- Multi-site enterprise (SSO)
Enterprise Governance Inquiry
For organizations with requirements that extend beyond standard self-service plans.
If your organization has governance, contractual, jurisdictional, or policy constraints that may impact documentation systems, you may submit an inquiry outlining your requirements for consideration.
TestLedger will review the information provided and respond regarding feasibility and any specifications required.
Submit Enterprise InquiryInquiries are reviewed for consideration only. No commitments implied. No sales outreach.
Frequently Asked Questions
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Your Next Audit is Coming
Get ahead of compliance requirements with cryptographic proof your records haven't been altered.