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Tag: ALCOA+

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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

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

Hands holding a glowing digital globe labeled “PIC/S Annex 22,” with connected icons representing AI, systems, and cloud controls.

AI HubDecember 18, 2025

What PIC/S Annex 22 Actually Means for Your Manufacturing Operations

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