Pre-validated. Continuously qualified. Built for regulated science.

Modern Quality Management
for Life Sciences

Accura is a cloud-native electronic Quality Management System (eQMS) purpose-built for life sciences organisations. Pre-validated by design, continuously qualified as it evolves.

Designed for regulated environments aligned with

FDA 21 CFR Part 11
ALCOA+ Data Integrity
GAMP 5 / CSA
ISO 13485
ISO 15189
ISO/IEC 17025
TGA, NATA & IANZ
FDA 21 CFR Part 11
ALCOA+ Data Integrity
GAMP 5 / CSA
ISO 13485
ISO 15189
ISO/IEC 17025
TGA, NATA & IANZ

Why Accura

Built for the lifecycle of regulated quality

Accura is architected to support quality systems throughout their entire lifecycle—from initial deployment through ongoing operation and platform evolution.

Pre-Validated by Design

Deployed on a validation-ready foundation with structured qualification evidence generated as part of the platform architecture.

Continuous Qualification

Every platform update goes through a controlled release process with automated qualification testing and structured validation evidence generation.

Regulatory-Ready Workflows

Built with FDA 21 CFR Part 11, ALCOA+ data integrity principles, electronic signatures, audit trails, and controlled quality processes.

Controlled Release Model

System updates are managed through structured release cycles where qualification activities are part of normal platform operation.

How It Helps

Spend less time managing compliance.
More time advancing science.

Accura reduces the operational burden of maintaining a validated quality system while keeping control, traceability, and audit readiness intact.

Reduce validation effort across system changes

Maintain continuous audit readiness

Improve traceability across quality processes

Replace fragmented quality tools with a single platform

Faster onboarding and system adoption

Reduce reliance on manual documentation

Platform Modules

Everything your quality system needs—unified

A single connected platform for managing documents, training, deviations, risk, audits, and supplier quality in regulated environments.

Document Control

Controlled documents with versioning, approvals, and full traceability.

Training & Competency

Role-based training assignments and compliance tracking.

CAPA Management

Structured deviation handling and corrective/preventive action workflows.

Change Control

Controlled evaluation and approval of regulated system and process changes.

Risk Management

Link risks to quality events, suppliers, audits, and CAPAs.

Audit Management

Plan, execute, and close audits with integrated findings tracking.

Explore All Modules

Built For

Life sciences organisations operating in regulated environments

Built for biotechnology, medical devices, diagnostics, pharmaceuticals, and laboratory teams where quality and compliance are critical to operations.

Biotechnology

Medical Devices

Diagnostics & Laboratories

Pharmaceuticals

Contract Research & Testing

Built for teams who need quality systems
that don’t slow them down

Accura helps life sciences and laboratory organisations maintain compliance, strengthen quality processes, and reduce administrative burden—while keeping full regulatory control and data integrity intact.

Schedule a Demo Talk to Our Team