Built for confidence in
regulated environments

Accura is designed for life sciences organisations where data integrity, traceability, validation and controlled quality processes are essential. The platform provides the foundation needed to manage quality operations with confidence throughout the system lifecycle.

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Data integrity by design

Trusted data is the foundation of regulated quality management.

Accura helps organisations maintain reliable, complete and traceable quality records throughout their lifecycle, supporting ALCOA+ principles and regulated data management practices.

Quality records should remain:

Attributable — Actions and records are linked to identified users
Legible — Information remains clear, accessible and understandable
Contemporaneous — Activities are recorded at the time they occur
Original — Records maintain their source integrity
Accurate — Information remains reliable and controlled

Supporting ALCOA+ principles: Complete • Consistent • Enduring • Available

Data integrity in regulated environments

Controlled electronic records with complete traceability

Support regulated quality activities with secure electronic records, approvals and controlled workflows.

Accura provides capabilities designed to support organisations managing electronic quality records in regulated environments.

Electronic signatures
User authentication
Role-based access controls
Complete audit trails
Version history
Controlled approvals
Record lifecycle management

Supporting validation throughout the system lifecycle

Support structured validation activities from implementation through ongoing system operation.

Implementing and maintaining a quality system requires structured validation activities, controlled changes and appropriate documentation. Accura provides a validation-ready foundation with supporting materials to help organisations manage their quality system lifecycle.

Structured qualification approach
Validation documentation support
Controlled system configuration
Change management processes
Release management practices
Supporting evidence for quality activities

Aligned with recognised quality standards and frameworks

Accura supports organisations operating in regulated environments by aligning with widely recognised regulatory expectations and quality management practices.

FDA 21 CFR Part 11

Supports requirements related to electronic records, electronic signatures and controlled system access.

GAMP 5 / Computer Software Assurance (CSA)

Designed around modern software assurance principles for regulated computerised systems.

EU GMP Annex 11

Supports expectations for computerised systems used within regulated pharmaceutical environments.

ISO 13485

Supports quality management requirements for medical device organisations.

ISO 15189

Supports quality requirements for medical laboratories.

ISO/IEC 17025

Supports quality management expectations for testing and calibration laboratories.

TGA, NATA & IANZ

Supports organisations operating within recognised accreditation environments.

Maintain confidence before, during and after audits

Access the information and evidence needed to demonstrate control over your quality processes.

Accura helps quality teams maintain visibility across records, activities and approvals, making it easier to prepare for inspections and demonstrate compliance.

Complete activity history
Traceable quality records
Controlled documentation
Transparent workflows
Faster access to supporting evidence
Improved inspection readiness