TestLedger™ Compliance Platform provides real-time, cryptographically sealed test documentation for regulated testing programs. Records are finalized at the point of execution and remain verifiable by auditors, eliminating reliance on post-hoc explanations during inspection.
Designed for regulated testing environments that require defensible documentation to reduce audit disruption and inspection risk. TestLedger supports continuous audit readiness by ensuring records are complete, immutable, and reviewable before an inspection begins.
Prevention matters more than cleanup.
Applicable to CLIA, DOT, and other regulated testing programs.
View how TestLedger produces inspection-ready documentation throughout the testing lifecycle.
Cryptographic Record Integrity
Test records are cryptographically sealed using SHA-256 at the time of finalization. Record integrity can be independently verified through hash comparison against exported documentation, providing objective evidence that records have not been altered.
Complete Audit Trail
Chain-of-custody audit logs capture operator actions, immutable timestamps, and event sequencing across the testing lifecycle. All activity remains reviewable without post-hoc reconstruction or narrative explanation.
Inspection-Ready Output
Documentation can be exported on demand in formats suitable for regulatory inspection, reducing last-minute preparation and minimizing audit disruption.
Designed to Support Regulatory Requirements Including
21 CFR Part 11
Electronic records and electronic signatures
DOT Programs
Federally mandated testing and reporting requirements
CLIA Standards
Regulated laboratory testing environments
HIPAA Safeguards
Administrative, technical, and physical protections for regulated data
What Auditors Actually Examine
Audits become high-risk events when teams must rely on explanations instead of records that stand on their own. During inspections, regulators focus on a small set of verifiable facts that 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 eliminates reliance on narrative explanations during inspection, reducing pressure on staff and minimizing audit-day uncertainty.
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.
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.
Record Lifecycle
Draft
Editable
Finalized
Complete
Sealed
Tamper-evident
Draft Window Controls
Records are editable only until operator-initiated finalization. All pre-finalization edits are logged in the audit trail. Configurable auto-finalization timeouts prevent indefinite draft states. Backdating is not possible—timestamps reflect actual server time at action.
Time Source & Offline Handling
Server time uses NTP synchronization. Offline records capture device time and are flagged as "offline-captured" upon sync. Both device timestamp and server reconciliation timestamp are preserved. Clock discrepancies exceeding thresholds trigger review flags.
Closed System Operations
TestLedger operates as a closed system with authenticated access. Exported records include cryptographic hashes for independent verification outside the system. Open system considerations apply when exports are transmitted to third parties—hash verification confirms integrity.
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
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.
Experience the Compliance Platform
From compliance profile selection to cryptographically sealed records, explore the complete documentation workflow in our interactive demo.
The interactive demo showcases core platform capabilities. All data entered is stored locally in your browser and is not transmitted to any server.
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 Documentation Workflows*
Reduction in audit preparation time versus manual compilation, based on internal case benchmarks
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
- ✓ HL7, DICOM, PDFs, JSON All medical formats
- ✓ 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 compliance documentation across multi-client regulated testing workflows
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 retrievable on demand for inspection evidence
- ✓ 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
Implements documentation and control patterns designed to map to established regulatory frameworks and existing SOP-driven quality systems.
Supports encryption in transit and at rest; role-scoped access; authenticated access logging. Sealed records are tamper-evident and retention-enforced.
HIPAA Controls
Designed to support HIPAA Security Rule technical safeguards (access control, audit controls, transmission security) as part of a broader compliance program
CLIA
Supports CLIA-oriented traceability metadata (operator, timestamps, site context), configurable retention, and review-friendly reporting
Electronic Records & Signatures
Implements integrity and auditability patterns consistent with Part 11 expectations, when electronic records are used under applicable predicate rules
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.
Part 11 Controls Matrix
Transparent mapping of Part 11 control expectations to TestLedger features and customer procedural responsibilities.
Regulatory Evidence Package
Sample exports and verification procedures to demonstrate record integrity during inspection.
Sample Record Exports
Example sealed record in PDF and JSON formats, including audit trail excerpt and signature manifestations.
- • PDF export with embedded hash
- • JSON with full record structure
- • Audit trail excerpt
Hash Computation Method
Technical specification of how record hashes are computed for independent verification.
- • Fields included in hash
- • Attachment binding method
- • Canonicalization rules
Independent Verification
Step-by-step procedure to verify record integrity without requiring TestLedger application access.
- • Offline verification steps
- • Third-party tool options
- • Command-line examples
Vendor Qualification Package
Available upon request for Professional and Audit-Ready customers. Includes Part 11 assessment, security overview, change control summary, business continuity documentation, and data retention specifications.
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 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
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, attribution, and traceability of changes, the answer should be system-generated evidence your organization can rely on.
The Cost of Documentation Failure
Regulatory deficiencies do not merely delay timelines. They compound risk across operations, financing, and market access. The relevant question is not whether audit-ready documentation has a cost—but whether an organization can absorb the consequences of proceeding without it.
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 most 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. Follow-up inspections and sustained FDA engagement are often required.
Valuation & Financing
Material Pressure
Regulatory setbacks routinely exert material pressure on valuation, investor confidence, and transaction terms. This is especially true for single-asset or pre-revenue companies where regulatory milestones drive financing events.
Prevention Costs a Fraction of Remediation
No system guarantees regulatory approval. However, purpose-built documentation infrastructure eliminates one of the most frequent and avoidable failure modes. Continuous compliance readiness requires modest, predictable investment. Reactive remediation consumes months of organizational time, significant capital, and irreplaceable focus that should be directed toward development and commercialization.
Complements Your Existing Systems
TestLedger augments existing EDC, LIMS, and Quality Management Systems by adding a defensible record layer that supports inspection-ready documentation. 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. Cryptographic sealing begins immediately upon record finalization.
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 completeness reporting*
- SSO/SAML integration
- HIPAA BAA available where applicable
- 99.9% SLA · Configurable retention (default 7-year)
*Batch completeness reporting verifies record traceability and documentation completeness; it does not make regulatory compliance determinations.
Try Demo14-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.
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Your Next Audit is Coming
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See how TestLedger supports inspection-ready documentation before auditors arrive.