✅ QC & Compliance

Quality built into every result and record.

A1 LIMS embeds quality control and regulatory compliance into every step of your laboratory workflow. Configurable QC rules, automatic OOS/OOT detection, electronic signatures, and immutable audit trails mean your lab is always inspection-ready — not just at audit time.

Configurable QC rules — Westgard, custom limits
Automatic OOS & OOT detection and investigation
21 CFR Part 11 & Annex 11 electronic signatures
Immutable audit trail on every record change
QC & Compliance — Live View
98.4%
QC pass rate
3
OOS results
1
OOT flagged
WESTGARD RULES — Control Chart
● Mean ● ±2SD warning ● OOC alert
AUDIT TRAIL — Last 3 events
✅ Result authorised — J.Smith — 09:42
⚠️ OOS flagged — SMP-2024-041 — 09:38
📋 QC batch approved — A.Khan — 09:15
Key Capabilities

Everything you need from qc & compliance

Built into every A1 LIMS subscription — no add-ons, no hidden modules. Configure it to your lab's exact workflow.

📐
Configurable QC Rules
Define acceptance criteria, warning limits, and control rules for every test — Westgard rules, custom ranges, or regulatory limits. QC failures flagged automatically before results are reported.
🚨
OOS & OOT Detection
Out-of-specification and out-of-trend results flagged instantly. Structured investigation workflows capture root cause, corrective action, and final disposition — all in one place.
✍️
Electronic Signatures
21 CFR Part 11 and EU Annex 11 compliant electronic signatures for result authorisation, document approval, and record changes. Full signature audit with timestamp and user identity.
📜
Immutable Audit Trail
Every change to every record logged automatically — what changed, who changed it, when, and why. Tamper-evident audit trail that stands up to any regulatory inspection.
📋
Document & SOP Control
Manage SOPs, method documents, and quality records within A1 LIMS. Version control, approval workflows, and controlled distribution — ensuring analysts always use current documents.
🏅
Accreditation Support
Built-in tools to support ISO 17025, ISO 15189, GLP, and GMP compliance. Generate evidence packages for assessments, manage non-conformances, and track CAPAs to closure.
How It Works

Simple to set up, powerful in use

Get up and running in days, not months. A1 LIMS is designed to be configured by lab managers — not IT specialists.

1
Define Your QC Framework
Set acceptance criteria, control limits, and Westgard rules for each test method. Configure OOS and OOT thresholds — done once, applied automatically forever.
2
Results Checked in Real Time
As results are entered or imported from instruments, A1 LIMS checks them against your QC rules automatically. Failures flagged immediately — no manual review required.
3
Investigation Workflow Triggered
OOS and OOT results trigger a structured investigation workflow. Analysts document findings, supervisors review, and CAPAs assigned — all tracked to closure.
4
Electronic Authorisation
Passing results routed to the authorisation queue. Authoriser reviews, signs electronically, and releases the result. Every step in the audit trail.
5
Always Inspection-Ready
Your complete quality record — QC data, audit trails, investigations, signatures — available instantly for any inspection, assessment, or client query.
98%
Average QC pass rate across customer labs
100%
Audit trail coverage — every record, every change
<5min
OOS investigation initiated after detection
Zero
Failed regulatory inspections reported
See QC & compliance in action
Tell us about your regulatory requirements and current QC challenges. We'll show you how A1 LIMS makes compliance a built-in capability — not an afterthought.
Contact Us → Back to homepage
✓ ISO 17025 ready ✓ 21 CFR Pt 11 ✓ GLP & GMP
Also In This Platform

Explore other A1 LIMS solutions

🔬
Sample Management
⚙️
Workflow Automation
QC & Compliance
📊
Analytics & Reporting
🔗
Integrations