Surge in Data Integrity Findings in GxP Inspections

Surge in Data Integrity Findings in GxP Inspections

Quality Systems Now
Published on: 15/04/2026

Recent inspection trends reinforce a fundamental principle: organisations cannot control risks that they cannot see. Data integrity failures, supply chain vulnerabilities, and system fragmentation all point to the same underlying issue—insufficient visibility into the true state of operations.

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TGA Compliance Principles 2026–2027: A Proactive and Risk-Based Approach

TGA Compliance Principles 2026–2027: A Proactive and Risk-Based Approach

Quality Systems Now
Published on: 03/02/2026

The TGA Compliance Principles for 2026 and 2027 reflect a proactive, risk-based approach to safeguarding public health through the regulation of therapeutic goods.

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Funding & Investor Expectations

Funding & Investor Expectations

Quality Systems Now
Published on: 20/01/2026

For therapeutic goods, biotechnology, and medical device startups, securing funding is not simply a matter of demonstrating innovative science. Investors require evidence of robust governance, clear regulatory pathways, and effective risk management.

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Happy New Year 2026: A MedTech Perspective on Innovation and Compliance

Happy New Year 2026: A MedTech Perspective on Innovation and Compliance

Quality Systems Now
Published on: 31/12/2025

May 2026 be a year of innovation, regulatory excellence, and continued progress in improving patient outcomes worldwide.

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