Documentation workflows for every stage of compliance readiness
Whether you're preparing for an inspection, recovering from a finding, or building a system for the first time — LabComplyx has a defined starting point.
Lab Health Score
Free
27-question self-assessment across 10 compliance domains. Results: gap report by domain, priority risk ranking, recommended next step. For any CLIA/CAP lab that wants an honest picture of where they stand.
Get My Free Health Score →Workflow Assessment
$1,500 fixed fee
Live review of CAPA, deviation, and documentation workflows against CLIA/CAP requirements. Deliverable: written gap analysis, risk-ranked remediation roadmap, one 60-minute debrief call. For labs preparing for accreditation renewal or responding to a recent inspection finding.
Book a Free Compliance ReviewGoverned AI Pilot
From $3,500
Implement 1–2 governed AI-assisted documentation workflows (typically CAPA and deviation management). Every AI-generated draft requires human QA review. Deliverable: configured workflow, controlled document templates, human-review checklist, ALCOA+ audit trail for pilot outputs.
Book a Free Compliance ReviewReadiness Sprint
$4,500–$6,500
Defined-scope engagement to prepare for a specific upcoming inspection or accreditation survey. Deliverable: prioritized remediation list, updated/new controlled documents, evidence binder, mock-inspection checklist. For labs with inspection date within 90 days.
Book a Free Compliance ReviewFractional Support
From $1,500/month
Ongoing compliance documentation operations for labs without a dedicated QA manager. All tiers include governed AI-assisted drafting, mandatory human review, ALCOA+ audit trail, monthly status report.
- Essentials $1,500/mo1–2 workflows
- Standard $2,500/mo3–5 workflows
- Comprehensive $4,500/moHigh-volume/multi-site
LabComplyx IS
- A governed AI-assisted documentation layer
- Structured workflows for CAPA, deviations, SOPs, inspection readiness
- Requires human review before any AI content is finalized
- ALCOA+ audit trail
- For small/midsized labs without dedicated QA
LabComplyx IS NOT
- A LIMS replacement
- A substitute for qualified QA judgment
- A guarantee of inspection passage
- An enterprise QMS (MasterControl, Qualio, Veeva)
- An FDA-cleared medical device