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Quality & Compliance

Investigations and CAPA, connected to the data

Quality events start where the data lives. HDLIMS opens investigations automatically, links them to the exact records involved, and tracks every corrective action to closure.

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Overview

Quality that starts where the data lives

When the QMS is separate from the lab system, investigators spend their first days reconstructing what happened: which sample, which instrument, which analyst, which reagent lot. Context gets lost, and trends across events stay invisible.

HDLIMS Quality & Compliance runs on the same data model as the LIMS. An out-of-specification result opens a Phase I investigation already linked to the sample, method, instrument calibration status, reagent lots and analyst training record. CAPAs, change controls and effectiveness checks remain traceable back to the original event.

What changes for your lab

Shorter investigation cycle times

Pre-linked context and guided workflows remove the reconstruction work that slows investigations down.

Visible quality trends

Events, root causes and CAPAs in one place reveal recurring issues before they become systemic.

Stronger inspection outcomes

Complete, connected records demonstrate control instead of requiring explanation.

Capabilities

Core Quality & Compliance capabilities

OOS and OOT investigations

Phase I and Phase II workflows aligned with FDA OOS guidance, triggered automatically from result evaluation.

Deviations and incidents

Capture planned and unplanned deviations with impact assessment, root cause analysis and approvals.

CAPA management

Corrective and preventive actions with owners, due dates, escalations and effectiveness checks.

Change control

Assess, approve and implement changes to methods, specifications, equipment and configuration with full traceability.

Audit trail review

Risk-based review queues that surface relevant audit trail entries, rather than raw logs nobody reads.

Document control

Controlled SOPs and methods with versioning, periodic review and read-and-understood training links.

Automatic investigations

Investigations that start themselves, with context

Result evaluation triggers the right workflow and pre-populates everything the investigator needs, so the first day of an investigation is spent investigating.

  • Automatic hold on dependent samples and dispositions
  • Pre-linked method, instrument, reagent and training records
  • Guided root cause tools such as 5 Whys and fishbone templates
  • Escalation from laboratory investigation to full-scale investigation and CAPA

Audit trail review

Audit trail review that people actually complete

Regulators expect meaningful review of audit trails for critical data. HDLIMS filters audit events by risk and presents them alongside the record they relate to.

  • Configurable rules that flag edits, deletion attempts, re-integrations and late entries
  • Review queues by product, method or analyst
  • Signed review records with comments
  • Metrics on review timeliness for management review

Audit trail review

  1. 01 Configurable rules that flag edits, deletion attempts, re-integrations and late entries
  2. 02 Review queues by product, method or analyst
  3. 03 Signed review records with comments
  4. 04 Metrics on review timeliness for management review

Inspection readiness

Be ready for an inspection on any given day

Pull a complete, cross-linked history for any batch, sample, instrument or person in minutes, instead of assembling binders.

  • One-click record history across LIMS, LES, SDMS and Quality
  • Quality metrics dashboards for management review and APR/PQR
  • Trend analysis of deviations and investigations by root cause
  • Controlled read-only access for auditors

Industries

Used across regulated industries

Pharmaceutical QC Biotech & Biologics Clinical & Diagnostics Food & Beverage

Works with

Related modules on the platform

LIMS Samples, tests, specifications, results and reporting, with complete traceability. LES Guided, paperless SOP execution with real-time checks and instrument capture. SDMS Automatic capture, parsing and long-term preservation of raw instrument data. Analytics & AI Dashboards, quality trending, self-service reporting and a governed AI assistant.

FAQ

Quality & Compliance: frequently asked questions

Does HDLIMS replace an enterprise QMS?
HDLIMS Quality & Compliance covers laboratory quality processes end to end. Organizations with an existing enterprise QMS can integrate it, for example by creating linked records there for site-wide CAPAs, while keeping lab investigations close to the data.
How does HDLIMS support FDA OOS guidance?
The OOS workflow follows the structure of the FDA guidance on investigating OOS results: a Phase I laboratory investigation to identify assignable cause, followed by a Phase II full-scale investigation when needed, with documented conclusions and approvals.
Can audit trails be turned off?
No. Audit trails for GxP records are always on and cannot be disabled or edited by any user, including administrators.

See Quality & Compliance in action on HDLIMS

Book a tailored demo with a lab informatics specialist. We map your sample types, methods and compliance requirements, then show you exactly how HDLIMS fits.

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