Every Action Logged. Every Report Ready. Every Audit Passed.
An unbreakable chain of evidence from first data entry to final signed report — and the reporting engine to turn it into compliant documents in minutes.
Why Data Integrity Is the Most Critical Issue in Laboratory Operations.
A data integrity finding does not mean someone cheated. It means a system allowed data to be changed without documentation, a result to be approved without a named authoriser, or a report to be issued without traceability.
LIMSera makes compliant behaviour the path of least resistance and non-compliant behaviour technically impossible.
From Data Entry to Signed Report. Six Stages.
Every action captured, every report generated, every signature verified, every record archived — automatically.
Capture
Every data event written to an immutable, cryptographically protected audit log automatically. No user action required.
Verify
Results spec-checked, IQC verified, and linked to instrument calibration status before they reach the reporting stage.
Generate
Approved results trigger automatic report generation from verified data using the correct template. Zero manual formatting.
Sign
Digital sign-off with FDA 21 CFR Part 11 compliant e-signatures. Identity confirmation, meaning statement, non-repudiation.
Distribute
Reports auto-distributed to clients, portals, regulatory systems, and archives upon final approval. Configurable per recipient.
Archive
Every report stored in a searchable indexed archive. Retrievable by any filter. As accessible on day 3,000 as on day 1.
Real-Time Audit Trail & Reporting. Every Action Documented.
Live audit log, report status, e-signatures, readiness scoring, and AI anomaly checks — all in one screen.
Audit Trail & Reporting. In One System.
Nine core capabilities — connected, audit-ready, and accreditation-aligned from day one.
Immutable Audit Trail
Append-only log with cryptographic integrity. User identity, timestamp, event type, previous and new values, and reason for change.
Report Builder
Configurable templates for test reports, CoAs, calibration certificates. Branding, layouts, regulatory language, signature blocks.
Auto Report Generation
Approved results trigger automatic report generation. No manual formatting, no copy-paste, no template selection.
e-Signatures
FDA 21 CFR Part 11 and EU GMP Annex 11 compliant. Identity confirmation, meaning statement, non-repudiation.
Conformity Statements
Auto-generated using configurable decision rules — simple acceptance, guard band, or shared risk per ISO/IEC 17025.
Amendment Management
Structured workflow with documented reason, authorised sign-off, version control. All versions preserved.
Readiness Dashboard
Live dashboard surfacing unsigned reports, open amendments, missing approvals — your readiness score at any time.
AI-poweredClient Portal
Branded self-service portal for clients to track samples, download signed reports, and retrieve certificates.
Archive & Retrieval
Searchable indexed archive. Retrievable by sample ID, report number, client, date, or test type.
How AI Enhances Audit & Reporting.
Pre-Report Anomaly Check
AI monitors results before reporting. If data was produced under flagged conditions, report generation is paused and quality notified.
Automated Quality Narrative
AI generates natural language summaries of quality trends, anomaly statistics, and compliance status for management reviews.
Audit Preparation Intelligence
Before a scheduled assessment, AI analyses record completeness and generates a prioritised gap list targeting areas of actual risk.
Your Data. Your Rules. Your Choice.
LIMSera Cloud
Instant setup. 99.9% uptime SLA.
Private / Self-Hosted
Full data sovereignty on your infrastructure.
Part of LIMSera LIMS
Start standalone. Expand when ready.
Regulatory Alignment
Data Integrity for Every Role.
Quality & Compliance Officers
Continuous visibility into data integrity status, audit trail completeness, and accreditation readiness.
Laboratory Directors
Professional, compliant reports generated automatically — zero formatting overhead, consistent presentation.
Analysts & Report Authors
No template hunting, no copy-paste. Reports generated from approved data automatically.
Client-Facing Teams
Branded self-service portal for report access. Consistent presentation to every client.
Regulatory & Submission
Regulatory-format reports meeting FDA, EMA, MHRA, WHO requirements — from verified data.
Accreditation Assessors
Complete, searchable, immutable records. Every question has a documented, accessible answer.
Everything You Need to Know About Audit & Reports.
Make data integrity and compliant reporting the easiest part of your day.
See LIMSera Audit & Reports configured for your accreditation framework, your report templates, and your data integrity requirements — in a live 30-minute walkthrough. No generic demos.
ISO 17025 · FDA 21 CFR Part 11 · GMP · Available worldwide · 30+ countries