LabLynx One

Full version history and change control on every file, with locking to prevent unauthorized concurrent edits on controlled documents.

Secure, traceable co-authoring within teams or with external collaborators, governed by permission controls.

Consistent, up-to-date file access anywhere, on any device.

Kanban-style card tracking drives visibility and efficiency across projects and document workflows.

Fully encrypted file storage with audit trails, version history, and change control aligned to regulatory requirements.

Supports both cloud-hosted and on-premises deployment, scaling from a single startup lab to a multi-site enterprise.

An on-premises hardware/software hybrid acting as the local nerve center — communicating directly with instruments, software, and edge devices, handling protocol translation and data normalization on-site.

Pre-configured integration profiles spanning pharmaceutical, biotech, environmental, forensic, and clinical instrumentation, with custom profiles available for unusual equipment.

Hosted on sciCloud.net, providing scalable, real-time integration management and orchestration, remote access, centralized updates, and system-wide visibility.

Taps into sciCloud.net's built-in AI-powered laboratory intelligence for anomaly detection, predictive analytics, and intelligent scheduling.

Integration workflows defined as visual, node-based flows — file watchers, parsers, transformers, validators, and API writers — without hand-written integration code.

Validates instrument outputs against defined ranges and formats before transmission, catching anomalies before they reach the platform.

Pre-built templates for CLIA, HIPAA, 21 CFR Part 11, GLP, GMP, ISO 9001, ISO 17025, ISO 15189, ISO 13485, CAP, and more — each mapping clauses to required controls and evidence.

Formal risk register aligned to ISO 31000, capturing likelihood/impact scoring, controls in place, residual risk, ownership, and treatment plans.

Structured Nonconformance → Root Cause → Corrective Action → Effectiveness Check → Closure workflow, with premature closure blocked until effectiveness is verified.

Full audit cycle support — scheduling, framework-driven checklists, finding categorization, and remediation tracking through to verified closure.

Policy creation, acknowledgment tracking, and gap analysis against active regulatory frameworks.

Automatically identifies personnel-related control requirements and assigns the corresponding course in LabCourses — closing the loop between compliance obligation and verified competency.

Browser-based authoring with rich text, embedded LabDrive documents, video, and interactive modules — no external authoring software required.

Assigning a role (e.g., "QC Analyst") automatically enrolls the person in every course required for that role — no manual course-by-course assignment.

Imports third-party training content from any SCORM- or xAPI-compliant source, including commercial safety and compliance libraries.

Randomized question banks, multiple question formats, configurable pass/fail thresholds, timed exams, and controlled attempt limits.

Automated reminders and re-enrollment when training with a defined renewal period comes due (annual HIPAA, biannual competency checks).

Every training activity generates a permanent record — course, version, completion date, score, attempts, and outcome — exportable for accreditation evidence.

Centralized record of client organizations, contacts, and relationship history, distinct from the operational Client Account data the Lab Portal module manages.

Structured quote generation, pricing/contract terms, and renewal tracking tied to each account.

Lead-to-close tracking for new business development, separate from existing client operational activity.

Surfaces upcoming contract renewals and at-risk accounts ahead of expiration.

Gated, step-enforced execution creates the contemporaneous record Part 11 inspectors look for — a live, system-enforced sequence rather than a narrative written up after the fact from memory.

Result entry and result review/release carry distinct signature levels, so authorship and approval are never satisfied by the same click from the same person.

Investigator, reviewer, and closure signatures build a defensible multi-step approval chain on every CAPA, with each signer's role and meaning explicit.

Author, reviewer, and approver signatures create the same multi-tier chain for every controlled SOP revision, keeping procedural documents as defensible as test results.

Specification/Limits Set — Product templates enforce identity and release testing before a Certificate of Analysis can be generated, closing off the shortcut of skipping identity testing.

Out-of-Specification Investigation records capture root cause and disposition decisions before a batch release call is finalized, not after product has already shipped.

Lot and expiration tracking on incoming components ties every finished batch back to the specific, identity-tested material lots that went into it.

Maps 21 CFR Part 111 clauses directly to the controls and evidence a facility already has in place, rather than requiring a separate compliance tracking system.

Specification/Limits Set — Regulatory templates compare results directly against label-claim tolerances, flagging a guarantee that's drifted out of range before it becomes a labeling violation.

Certificate of Analysis reporting documents the guaranteed-analysis verification for producers and state regulators in the format each typically expects.

Multi-jurisdiction regulatory mapping keeps state-by-state AAFCO adoption variations organized, since requirements can differ meaningfully by state and by commodity.

Real-time, step-enforced data capture is precisely what makes execution contemporaneous rather than reconstructed after the fact from a analyst's recollection.

Every module's create, edit, and delete history is timestamped and attributable by design across the entire platform, not added as an afterthought to one module.

Version and revision history preserve the original entry alongside every subsequent edit, satisfying the Original requirement without sacrificing the ability to correct honest mistakes.

Full file-level version history keeps controlled documents complete and enduring across their entire lifecycle, from draft through retirement.

Chain-of-Custody Transfer Log templates create the auditable, time-stamped custody record ANAB assessors and defense attorneys alike will scrutinize.

Qualification status gates task assignment, so only currently-qualified analysts perform regulated examinations — and that qualification history remains available for later challenge.

Retains case-related SOPs and controlled documents with the version history an appeal may require years after the original examination.

Manages the internal audit cycle ANAB accreditation maintenance requires between formal assessment visits, keeping continuous compliance rather than periodic scrambling.

Composite/Bulk Sample and General Chemistry/Microbiology Test Order templates standardize germination and purity testing procedure across every analyst running the test.

Certificate of Analysis reporting documents test results back to growers, producers, and certifying agencies in the format each expects.

Retest/Resample Request workflow formally handles a borderline germination result that warrants a repeat test before a final certification decision.

Calibration and qualification status on every instrument used in aerospace testing is tracked and immediately audit-ready, supporting the traceability chain from the equipment side.

Analytical Instrument Registration and Calibration Event templates support the part-to-instrument traceability chain AS9100 auditors expect to see documented.

Multi-standard framework mapping across ISO 9001, IATF 16949, and AS9100 for facilities carrying more than one certification simultaneously.

Retains legacy SOP versions alongside current ones, preserving the full procedural history across the ASCLD/LAB-to-ANAB transition without losing either version.

Case and evidence records from the ASCLD/LAB era remain retrievable under Sample Disposal/Retention Record templates, regardless of how old the case is.

Internal audit management can track continuity-of-practice evidence across both accreditation eras in a single system.

Recurring/Scheduled Sampling Program templates keep trend-relevant testing consistent, sample after sample, on the schedule an asset-health program depends on.

Calibration Event tracking on wear-metal analyzers keeps trend data comparable over time, catching instrument drift before it corrupts a trend line.

Instrument data bridge feeds high-volume wear-metal analyzer output directly into results without manual transcription error, preserving the precision the trend analysis depends on.

General Chemistry Test Order and Specification/Limits Set templates enforce method-specific fuel testing consistently across every batch and every analyst.

Certificate of Analysis reporting documents full-panel batch conformance for regulators and downstream distributors before release.

Keeps the analytical instruments used in fuel testing within their required calibration windows, since an out-of-calibration instrument invalidates the whole batch result.

Per-course completion templates and expiration tracking produce the competency evidence CAP checklists specifically require, retrievable by analyst and by method.

Reference Range/Clinical Limits Set and Critical Value Callback Record templates document clinical-testing checklist items directly, in the format inspectors expect.

Reagent Lot tracking supports the biorepository-specific checklist items covering specimen and reagent handling and storage.

Pre-built CAP framework templates map checklist items directly to the controls and evidence already documented elsewhere in the system.

Method- and equipment-specific qualification templates match CLIA's complexity-tiered personnel requirements, scaling documentation appropriately by test complexity.

Result entry and review signature levels enforce the qualified-reviewer requirement before a patient result is allowed to release.

Calibration and maintenance history keeps every test system's QC documentation audit-ready, regardless of complexity tier.

Generates the assessed competency evidence CLIA moderate- and high-complexity testing personnel requirements specifically ask for, not just attendance records.

Recurring/Scheduled Sampling Program templates keep permit-driven monitoring on schedule automatically, closing the gap that leads to late-report violations.

Specification/Limits Set — Regulatory templates compare results directly against that specific facility's permit limits, not a generic benchmark.

Internal Audit Finding tracking supports the periodic self-assessment many NPDES permits require as a condition of continued permit coverage.

Maps state-specific NPDES program variations for labs reporting across multiple permit jurisdictions with differing requirements.

Client Account Profile and Status Inquiry templates keep each client's specific commitments visible and self-service, without staff needing to track them manually.

Tracks contract terms, pricing, and renewal timing separately from the operational testing record, so sales-side and lab-side data stay properly separated.

Client Complaint tracking captures any missed commitment as a documented, closed-loop case rather than an informal apology that leaves no record.

General Chemistry and Microbiology Test Order templates are built around specific method identifiers, keeping method selection explicit and traceable rather than left to analyst discretion.

Calibration records confirm the instrument was qualified for the specific method's detection limits at the time testing was performed.

Out-of-Specification Investigation captures any QC failure against a method's defined acceptance criteria, with root cause tracked before results are reported.

Rich-text entries built from protocol templates capture the metadata and experimental context that makes a data set findable and interpretable long after the fact.

Cross-entry search across the accumulating research record is what actually makes data findable in practice, not just theoretically well-labeled.

Supports multi-institution collaboration and consistent file access, keeping shared research data accessible across a distributed team even as individual members move on.

Microbiology Test Order and Certificate of Analysis templates document environmental monitoring and finished-product testing results together.

CAPA Action Plan and Internal Audit Finding tracking keep preventive-control documentation audit-ready rather than assembled reactively.

Lot and expiration tracking is what makes rapid recall-readiness tracing actually possible, rather than theoretically achievable.

HACCP/FSMA framework mapping assembles recall-readiness evidence packages before an auditor or an actual recall situation ever asks for them.

Gated, step-enforced execution is the core mechanism that prevents an undocumented deviation from happening unnoticed in the first place.

Calibration and PM event templates produce the equipment qualification evidence GMP audits consistently require.

Structured Nonconformance through CAPA workflow, with premature closure blocked until effectiveness is actually verified, not just claimed.

Formal risk register and GMP framework mapping across whichever manufacturing-adjacent regulation applies to a given facility's products.

Microbiology Test Order and Specification/Limits Set — Regulatory templates enforce PMO's specific numeric limits on every incoming load.

Certificate of Analysis reporting documents compliance back to the processor on the unusually tight timeline dairy testing demands.

Retest/Resample Request handles a borderline antibiotic screen or bacterial count that needs confirmation before a full-load rejection decision is made.

Version/revision history preserves the complete experimental record independent of any one researcher's continued involvement with the institution.

Retains finalized protocols and data-related documentation on the same platform-wide retention schedule as regulated content, without a separate system.

Supports the long-term, multi-institution file access many funder data-sharing plans specifically require as a condition of the award.

Structured, timestamped log entries are exactly the format CCP monitoring records need — frequent, short, consistent, and immediately time-stamped.

CAPA Action Plan tracking documents the corrective action a CCP deviation requires before product is allowed to proceed to the next stage.

HACCP framework mapping and recall-readiness evidence packages tie CCP monitoring records to the broader food-safety compliance picture.

Role-level default permissions with entry-level sharing controls keep patient-identifiable data visible only to those roles that specifically need it.

Patient demographic and specimen fields are scoped to the roles that specifically require clinical access, rather than visible platform-wide.

Every access and edit is logged and attributable, directly supporting the breach-scope determination a HIPAA incident investigation requires.

Maps HIPAA's specific administrative, physical, and technical safeguard requirements to the controls already documented and in place.

General Chemistry Test Order and Specification/Limits Set — Product templates support the specification-driven testing PPAP approval requires.

Nonconformance rate and CAPA closure tracking by production run feeds directly into SPC-style trend reporting rather than sitting in isolated case files.

Multi-standard framework mapping across ISO 9001, IATF 16949, and AS9100 for suppliers certified to more than one automotive or aerospace standard.

Author and reviewer signature levels distinguish original authorship from a witnessing countersignature, both of which carry independent evidentiary weight.

Every edit preserved and comparable side-by-side is the backbone of an entry's evidentiary value in a priority dispute years later.

Time-stamped, attributable history makes a late alteration intended to strengthen a priority claim detectable rather than invisible to later scrutiny.

Reagent Lot patterns adapted for specimen lots track storage location, condition, and quantity as structured, searchable fields.

Continuous freezer and storage-condition monitoring integration turns an overnight excursion into a documented, actionable event instead of a silent, undiscovered failure.

Sample Disposal/Retention Record templates keep every specimen's retention schedule tracked and properly enforced over its entire storage life.

Gated execution against validated methods supports the design verification and validation testing ISO 13485 requires before a device design is finalized.

CAPA workflow blocks premature closure until effectiveness is actually verified with follow-up evidence, directly matching ISO 13485's expectation.

Risk register aligned to ISO 31000 connects testing-level quality events to the device's broader, ongoing risk management file.

Calibration events link to reference standards, building the measurement traceability chain ISO 17025 assessors specifically verify during an audit.

Per-course completion templates with expiration tracking produce the personnel competence evidence assessors expect to see documented, not just claimed.

Specification/Limits Set templates and full audit trail support the method validation and result traceability the standard requires throughout.

Pre-built ISO 17025 framework template maps clauses directly to the controls and evidence already documented elsewhere in the system.

General Chemistry Test Order and Specification/Limits Set — Product templates support both raw material qualification and finished-product release testing.

Lot and expiration tracking on raw materials ties every finished batch to specific, qualified, traceable ingredient lots.

ISO 22716 framework mapping documents the cosmetics-specific GMP controls a facility has in place for audit purposes.

Structured Nonconformance through CAPA workflow, with root-cause and effectiveness tracking, is the operational core of practical ISO 9001 compliance.

Standard SOP and policy templates enforce the consistent, documented process control the standard requires across every department.

Internal audit management supports the scheduled self-assessment program ISO 9001 certification maintenance requires between external audits.

Protocol-specific entry templates keep experimental documentation aligned with what was actually IRB/IACUC-approved, rather than what was more convenient in practice.

Retains the approved protocol itself as a controlled document, version-linked directly to the study record it governs.

Provides a structured path for documenting and reporting any protocol deviation back through the appropriate institutional channel promptly.

Chain-of-Custody Transfer Log templates create the field-to-report custody record NELAC-TNI assessors specifically expect to review.

Calibration records confirm instruments met each method's required detection limit at the specific time testing was performed.

Multi-jurisdiction regulatory mapping keeps state-specific NELAC-TNI program variations organized in a single, coherent view.

Specification/Limits Set — Regulatory templates can be configured per state program, keeping multi-state limits distinct rather than conflated into one generic set.

Microbiology and General Chemistry Test Order templates cover the pesticide, heavy metal, and potency panels each individual state requires.

Multi-jurisdiction regulatory mapping is essential here, since state cannabis/hemp requirements vary more than almost any other regulatory category.

Environmental Water Sample and Specification/Limits Set — Regulatory templates can be scoped to the specific state program a given sample falls under.

Multi-jurisdiction regulatory mapping across whichever state environmental program applies keeps requirements from being conflated across state lines.

Specification/Limits Set — Regulatory templates compare nutrient guarantee results against each specific state's tolerance rather than one generic standard.

Certificate of Analysis reporting documents compliance in the format needed to support state registration submissions.

Multi-jurisdiction mapping keeps each state's fertilizer program requirements distinct for producers selling across multiple state lines.

General Chemistry and Microbiology Test Order templates support the specific methods APHIS animal health testing requires.

Certificate of Analysis reporting generates the documentation livestock health certificates for interstate or international movement require.

Provides a structured path for documenting and routing a reportable-disease result promptly to the appropriate regulatory authority.

Microbiology Test Order templates document pathogen testing against FSIS's specific statistical performance standards over time.

Lot and expiration tracking supports the rapid traceability an FSIS-coordinated recall action demands on short notice.

HACCP/FSMA framework mapping extends to FSIS-specific recall-readiness evidence packages tailored to meat and poultry facilities.

Maps HECVAT questionnaire sections directly to the security and privacy controls a lab informatics vendor already has documented, speeding response to a university's request.

Provides the access control and SSO-compatible authentication model HECVAT specifically asks vendors to describe.

Documents the logging and monitoring capability HECVAT's security section expects a vendor to have in place.

Retains the completed, current HECVAT itself as a version-controlled reference document, ready to share with a university's procurement or security office on request.