Your Accreditation Audit. Ready Any Day of the Year.
LIMSera Compliance Manager maps your entire laboratory quality system to ISO/IEC 17025, GLP, GMP, and all major frameworks — so compliance is a continuous, evidenced, operational state.
When Compliance Is Reactive, Every Audit Is a Risk.
The cost of a failed assessment is not just corrective action — it is the time, resource, and reputational damage that follows.
Compliance managed in spreadsheets and shared drives
SOPs in one place, CAPAs in another, training records in email. No single source of truth for your quality system.
Gaps discovered at assessment, not before
Expired documents, overdue CAPAs, and incomplete training records surface when the assessor finds them — not when your team can fix them.
No visibility into accreditation readiness
Quality managers cannot answer ‘Are we audit-ready today?’ without manually checking multiple disconnected systems.
Data integrity relies on discipline, not systems
Without immutable audit trails and electronic signatures, data integrity depends on individual behaviour — not system-enforced controls.
The Complete Compliance Lifecycle. Managed Continuously.
Six connected stages. Every action documented. Every gap surfaced before an assessor finds it.
Every clause of your accreditation standard mapped, documented, and linked to evidence. Gaps surfaced proactively.
Centralised, version-controlled document library with review cycles, approval workflows, and role-based access.
Structured root cause analysis, action tracking, effectiveness review, and formal closure. Overdue CAPAs auto-escalate.
Plan, schedule, execute, and document internal audits. Findings linked to corrective actions with closure tracking.
Personnel qualifications, training records, competency assessments, and authorisation management with renewal alerts.
Management reviews, risk register updates, compliance KPIs, and accreditation readiness scoring — all in one place.
Real-Time Compliance Dashboard. Audit-Ready Every Day.
Document control, CAPA tracker, audit findings, risk register, and personnel alerts — all visible in one screen, from any device.
Everything Your Quality Team Needs. In One System.
Nine core capabilities — connected, configured, and accreditation-ready from day one.
Standard Clause Mapping
Every requirement mapped, documented, and evidenced. Compliance gaps surfaced proactively — not at assessment.
Document Control
Version-controlled library for SOPs, methods, and policies. Defined approval workflows. Always the current version.
CAPA Management
Root cause analysis, owner assignment, due dates, effectiveness review, and closure. Overdue CAPAs auto-escalate.
AI trend detectionNonconforming Work
Identify, document, investigate, and resolve deviations. Every nonconformance linked to its corrective action.
Risk Register
Document risk sources, assess likelihood and impact, assign mitigation controls, track effectiveness over time.
Internal Audit Management
Plan, schedule, execute, and document audits. Finding records, corrective action linkage, and closure tracking.
Proficiency Testing & ILC
Record PT participation, document results, assess z-scores, and record required corrective actions.
Measurement Uncertainty
GUM-compliant uncertainty calculation, documentation, and reporting. Contributions, combined and expanded uncertainty per method.
Personnel Competency
Track qualifications, training, competency assessments, and test authorisations. Automated renewal alerts.
AI gap detectionCompliance That Anticipates. Not Just Documents.
Traditional compliance is reactive — problems found at audits. LIMSera AI shifts compliance from reactive to predictive.
Compliance Gap Identification
AI continuously monitors open CAPAs, expiring documents, approaching review dates, and incomplete training — surfacing gaps before an assessor finds them.
Risk-Based Prioritisation
AI applies risk weighting based on standard clause, historical significance, and time to next assessment — helping prioritise by actual risk.
Nonconformance Trend Analysis
When the same nonconformance recurs across analysts, instruments, or time periods, AI surfaces the systemic pattern a single CAPA has not resolved.
Live Compliance Health Score
Real-time score across all standard requirements — updated as actions complete, documents are approved, and records maintained.
CAPA-2026-009, 012, 014 past due date. Combined risk score: High. Escalation triggered to QA Head.
SOP-055 Internal Audit Checklist v2.0 expires Apr 22. Review cycle not initiated. Author notified.
Analyst K. Ota completed competency assessment for HPLC Method A. Authorisation renewed for 12 months.
Your Data. Your Rules. Your Choice of Deployment.
Compliance Manager is available standalone or as part of the full LIMSera platform — in the cloud, self-hosted, or hybrid.
LIMSera Cloud
Instant setup. No infrastructure. Automatic updates and 99.9% uptime SLA.
Private / Self-Hosted
Full data sovereignty. Deploy on your own infrastructure with complete control.
Part of LIMSera LIMS
Compliance Manager alone today. Expand to the full platform when ready.
Standards Supported
Every Role in Your Quality Programme.
Quality Managers
Own the complete compliance programme from a single dashboard — every open action, expiring record, and compliance gap visible.
Accreditation Coordinators
Manage documentation and evidence trails for any accreditation body — without searching across disconnected systems.
Laboratory Directors
Real-time compliance posture view — not just at assessment time, but every working day.
Analysts & Technicians
Always work against current, approved methods with competency records maintained automatically.
IT & Data Governance
Full audit trail, role-based access, and data integrity architecture aligned to 21 CFR Part 11.
Senior Management
Management review inputs, risk register status, and compliance KPIs for executive oversight.
Everything You Need to Know About Compliance Manager.
Make every day an audit-ready day.
See LIMSera Compliance Manager configured for your accreditation framework, your quality system, and your compliance requirements — in a live 30-minute walkthrough. No generic demos.
No commitment required · Implementation support included · Available worldwide · 30+ countries