LATEST NEWS
Season’s Greetings and Merry Christmas from Quality Systems Now
From everyone at Quality Systems Now, we wish you a Merry Christmas and a positive start to the New Year. Thank you for your continued engagement, professionalism, and commitment to quality and compli... ...more
News
December 17, 2025•4 min read
The Role of Compliance in Product Development
Product development compliance is an essential scientific discipline that underpins successful innovation in regulated industries. ...more
Compliance
December 15, 2025•5 min read
Clarifying and Strengthening the Regulation of Medical Device Software Including Artificial Intelligence (AI)
The regulator’s mid-2025 review acknowledges that the existing, technology-agnostic, risk-based framework remains fundamentally appropriate for SaMD and AI-enabled medical devices ...more
News
December 10, 2025•5 min read
Case Study: QMS Gap Assessment and Integration
The QMS gap assessment and integration project demonstrated how systematic evaluation, scientific documentation practices, and targeted training can achieve compliance with PIC/S PE 009 and Annex 3 re... ...more
Quality Culture
December 08, 2025•6 min read
ISO Accreditation Readiness Scorecard
GMP licensing and ISO accreditation are critical milestones for therapeutic goods manufacturers, testing laboratories, and biotechnology companies. A readiness assessment using a structured scorecard ... ...more
ISO Recommendations
December 03, 2025•4 min read
AusBiotech 2025 International Conference
AusBiotech 2025 offered a valuable reflection point for the biotechnology sector, particularly regarding GMP and regulatory compliance. ...more
News ,GMP
December 01, 2025•3 min read
Think You're Ready for Your Next GMP Inspection?
Preparing for a GMP inspection requires a comprehensive, structured approach encompassing quality management systems, documentation, facilities, equipment, personnel, process control, and risk managem... ...more
GMP
November 27, 2025•4 min read
Establishing Readiness for Clinical Trial Manufacturing
Establishing readiness for clinical trial manufacturing is a multidimensional process requiring attention to regulatory compliance, facility and personnel preparedness, quality systems, process valida... ...more
Medtech
November 24, 2025•5 min read
Is Your Warehouse Process Designed for GMP or ISO Compliance?
Warehousing is a critical component of the supply chain for therapeutic goods, biotechnology products, and laboratory materials. ...more
GMP
November 19, 2025•6 min read
What is the Difference Between R&D Documentation and GMP Documentation?
The regulatory environment surrounding R&D documentation is generally less stringent than that governing GMP documentation. ...more
GMP
November 17, 2025•5 min read
QMS Gap Assessment and Integration
The QMS gap assessment and integration conducted by QSN demonstrates a comprehensive approach to achieving regulatory compliance in the therapeutic goods sector. ...more
QMS
November 10, 2025•5 min read
GMP Certification Milestones & Global Inspection Activity
GMP certification milestones and global inspection activity are more than regulatory formalities; they represent critical mechanisms for ensuring product quality, patient safety, and corporate credibi... ...more
GMP
November 05, 2025•6 min read
Temporary GMP Exemptions for Bacteriophage Therapies in Australia
The proposed temporary GMP exemption by the TGA for personalised bacteriophage therapy manufacture in Australia marks a significant regulatory development for the emerging phage‑therapy sector. ...more
News
November 02, 2025•6 min read
Case Study: Supporting a Manufacturer Transitioning to ISO 13485 Compliance
This case study demonstrates how Quality Systems Now provides end-to-end support for manufacturers transitioning into medical device production. By combining standards expertise, practical implementat... ...more
Compliance
October 29, 2025•4 min read
New Regulations to Strengthen Medical Device Patient Safety
The introduction of mandatory reporting requirements for medical device-related adverse events marks a significant step forward in enhancing patient safety in Australia. ...more
News
October 26, 2025•4 min read
Understanding the Gaps and Overlaps Between ISO 13485, EU MDR, and MDSAP
ISO 13485, EU MDR, and MDSAP share significant commonalities in quality management, risk control, post-market surveillance, and documentation practices. However, gaps remain in clinical evaluation, UD... ...more
ISO13485 Certification
October 22, 2025•6 min read
General GxP Requirements – GLP, GCP, and GMP
GLP, GCP, and GMP form the backbone of GxP requirements in the life sciences sector. While each framework has a distinct focus—laboratory studies, clinical trials, and manufacturing—they share core pr... ...more
GMP
October 18, 2025•5 min read
Understanding the Therapeutic Goods Legislation Amendment Effective from 1 October 2025
Understanding the Therapeutic Goods Legislation Amendment Effective from 1 October 2025 ...more
Therapeutic Goods Administration ,News
October 13, 2025•3 min read
Compliance Isn’t a Cost Center, It’s Your Launch Strategy
When you’re ready to scale or license your innovation, buyers and investors want one thing: regulatory assurance. ...more
Compliance
October 12, 2025•5 min read
Public Feedback sought on updates to Good Manufacturing Practice (GMP) Guidelines
The Therapeutic Goods Administration (TGA) has opened public consultation on proposed updates to the Good Manufacturing Practice (GMP) guidelines that regulate the manufacture of therapeutic goods in ... ...more
GMP
October 08, 2025•7 min read
A Startup’s Guide to Regulatory and Commercial Readiness
For many startups, the steepest learning curve lies not in the innovation itself—but in understanding and meeting the rigorous expectations of regulators such as the Therapeutic Goods Administration (... ...more
Compliance
October 05, 2025•7 min read
Understand What Is the Risk Management Plan (RMP) and Risk Management File (RMF)
Risk Management Plan (RMP) and the Risk Management File (RMF). Although closely related, they serve different but complementary purposes. Understanding how these fit into your broader quality and regu... ...more
Quality Culture
October 01, 2025•7 min read
Companies With Strong Quality Cultures Resolve Issues 25% Faster
Research and practical experience show that companies with strong quality cultures consistently resolve issues up to 25% faster than those without. ...more
Quality Culture
September 29, 2025•6 min read