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Tag: GxP compliance

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A smiling female clinical research professional in a navy suit stands in a modern office, holding a tablet displaying data next to a large monitor showing a clinical trial process flow diagram.

Clinical Trials, GxP Auditing5 days ago

Quality Management Systems in Australian Clinical Trials: Sponsor Responsibilities

Australian clinical trial professionals reviewing GCP data management records on validated systems, demonstrating ALCOA+ data integrity and TGA inspection readiness under ICH E6(R3).

GxP AuditingJanuary 19, 2026

Data Management and Good Clinical Practice – An Australian Perspective

Pharmaceutical professionals overseeing AI decision-support systems under PIC/S Annex 22 AI validation requirements in a GMP manufacturing facility.

AI Hub, BusinessJanuary 18, 2026

PIC/S Annex 22 Explained: What Pharmaceutical Manufacturers Must Know About AI Validation

Two pharmaceutical and data governance professionals reviewing AI documentation and privacy controls in a regulated healthcare setting in Australia.

AI HubJanuary 17, 2026

Privacy in the AI-Enabled Pharmaceutical Landscape

A professional reviewing printed documentation at a desk in a modern office environment, focused and engaged

Business, GxP AuditingJanuary 15, 2026

Good Document Practice – Pharmaceutical Industry Considerations

Three pharmaceutical quality professionals review a GMP audit checklist on a monitor in a modern Australian quality office, collaborating at a standing desk.

DevelopmentJanuary 13, 2026

Seven Golden Rules GMP Compliance

Two professionals reviewing clinical research data, charts, and regulatory documents together at a desk using a laptop.

GxP AuditingJanuary 1, 2026

GCP Consultant Australia: 20 Good Clinical Trial Updates for 2025 That Should Be Shared

Multidisciplinary pharmacovigilance professionals reviewing an AI-enabled safety dashboard during a collaborative meeting focused on adverse event trends, regulatory oversight, and patient safety.

PharmacovigilanceDecember 30, 2025

Pharmacovigilance Consultant View – Top 20 Pharmacovigilance Updates for 2025

Pharmacovigilance professional reviewing Australian TGA safety reporting requirements with regulatory colleague

PharmacovigilanceDecember 29, 2025

Pharmacovigilance Services in Australia: How to Appoint Your Local Contact Person & Ensure TGA Compliance

Clinical operations professional reviewing regulatory documentation while analysing validation and performance data on a laptop dashboard

AI Hub, GxP AuditingDecember 22, 2025

Computer System Validation in Clinical Trials

Professionals reviewing inspection readiness and Part 11 documentation alongside a validated digital system in a regulated environment

GxP AuditingDecember 21, 2025

Understanding 21 CFR Part 11 Requirements

A team of pharmaceutical quality and compliance professionals reviewing data integrity reports and audit documents during a meeting.

Development, GxP Auditing, PharmacovigilanceNovember 12, 2025

Quality and ALCOA+ Principles: Building Data Integrity You Can Defend Under Inspection