Electronic Records & Signatures
Controls that support secure records, approvals, and accountable user actions.
COMPLIANCE CAPABILITIES
A deeper compliance layer beneath the platform
Accura provides the compliance controls, data integrity, audit trails, and validation support needed to manage quality with confidence.
Data Integrity Principles
Controls that support attributable, accurate, complete, and traceable quality data.
Validation & Audit Evidence
Documentation, change control, and audit trail support across the system lifecycle.
REGULATORY ALIGNMENT
Aligned with recognised quality
standards and frameworks
FDA 21 CFR Part 11
Electronic records, electronic signatures, and controlled system access.
EU GMP Annex 11
Computerised systems used in regulated pharmaceutical environments.
GAMP 5 / CSA
Risk-based approaches to computerised system validation and assurance.
ALCOA+ Data Integrity
Reliable, complete, and available data throughout the record lifecycle.
ISO 15189 / ISO 17025
Quality and competence requirements for laboratories and testing environments.
CONTROLLED ELECTRONIC RECORDS
Records, approvals and signatures with complete accountability
The platform supports quality control with electronic signatures, verified users, role-based permissions, and audit trails for traceable actions across records and workflows.
Electronic signaturesUser authenticationRole-based access controlsAudit trailsVersion historyControlled approvals
DATA INTEGRITY BY DESIGN
Support ALCOA+ principles across quality records
Trusted data is the foundation of regulated quality management. We help quality records remain reliable, complete and traceable throughout their lifecycle.
Attributable
Actions and records are linked to identified users.
Legible
Information remains clear, readable and accessible.
Contemporaneous
Activities are captured with time-based context.
Original
Records maintain source integrity and lifecycle history.
Accurate
Information remains reliable, controlled and reviewable.
Plus
Complete, consistent, enduring and available.
VALIDATION LIFECYCLE
Validation support from
implementation through
ongoing change
Accura provides a validation-ready foundation with supporting documentation, controlled configuration and release management practices to help teams maintain confidence as the system evolves.
01
Implementation planning
Define intended use, scope and quality process requirements.
02
Configuration control
Set up workflows, roles, permissions under controlled governance.
03
Qualification evidence
Use supporting documentation and test evidence to support qualification and deployment.
04
Controlled change
Maintain confidence through release management and change impact review.
AUDIT READINESS
Find the evidence you need before, during and after audits
We help quality teams access records, approvals, activity history and supporting evidence more quickly, reducing the manual burden of audit preparation.
Traceable quality recordsComplete activity historyControlled documentationFaster evidence accessInspection readinessTransparent workflows