LATEST NEWS
QSN Isn’t Just External Support — It’s Capability Building That Stays With the Company
Investing in QSN’s capability-building approach transforms compliance from a temporary activity into a sustainable organisational strength, reinforcing quality culture, reducing risk, and enabling lon... ...more
QMS ,Compliance
February 04, 2026•5 min read
TGA Compliance Principles 2026–2027: A Proactive and Risk-Based Approach
The TGA Compliance Principles for 2026 and 2027 reflect a proactive, risk-based approach to safeguarding public health through the regulation of therapeutic goods. ...more
News
February 03, 2026•5 min read
Achieving Organizational Discipline Around Quality Records
Achieving organizational discipline around quality records is a scientific and systematic endeavor that extends across regulatory, operational, and cultural dimensions. ...more
Procedures and Policies ,Quality Culture
January 29, 2026•5 min read
From Design Controls to Clinical Evidence
From design controls to clinical evidence, the development of therapeutic goods is a continuous, interconnected process grounded in scientific discipline and regulatory compliance. ...more
Quality Culture
January 27, 2026•6 min read
Operational Knowledge Gaps
Quality Systems Now provides more than external support — it builds capability within startups, embedding regulatory, quality, and operational knowledge. By implementing structured QMS, regulatory pre... ...more
Leadership Values
January 22, 2026•4 min read
Funding & Investor Expectations
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 r... ...more
News
January 20, 2026•4 min read
Establishing a Robust Quality Management System (QMS)
For therapeutic goods, biotechnology, and medical device startups, a robust QMS is essential for regulatory compliance, operational efficiency, and investor confidence. Early-stage companies often und... ...more
QMS
January 15, 2026•5 min read
Regulatory Complexity & Compliance Burden
Regulatory complexity and compliance burden are inherent challenges in the therapeutic goods and biotechnology sectors. Startups must contend with fragmented, technical, and constantly evolving global... ...more
Compliance
January 13, 2026•4 min read
Case Study SaMD and IVD Medical Device Start-Up
This case study illustrates how targeted ISO 13485 support can enable a SaMD and IVD medical device start-up to establish robust, compliant quality systems and achieve audit readiness. ...more
Medtech
January 07, 2026•5 min read
Can you help with our next audit or inspection?
Can you help with our next audit or inspection? Absolutely. Quality Systems Now offers audit readiness reviews, mock inspections, and audit response assistance to support organisations through every s... ...more
Audit Readiness
January 04, 2026•5 min read
Pharmaceutical Quality Management Systems for the Future
The future of pharmaceutical Quality Management Systems lies at the intersection of regulatory rigor, technological innovation, and organizational excellence. ...more
QMS
January 02, 2026•5 min read
Happy New Year 2026: A MedTech Perspective on Innovation and Compliance
May 2026 be a year of innovation, regulatory excellence, and continued progress in improving patient outcomes worldwide. ...more
News
December 31, 2025•4 min read
Validation Gaps That Kill Launch Timelines
Validation is a critical component of quality management that ensures medical devices are safe, effective, and compliant. For MedTech innovators, gaps in validation ...more
Quality Culture
December 25, 2025•5 min read
Fast Track to ISO 13485 for MedTech Innovators
With the support of GMP and regulatory compliance specialists like Quality Systems Now, organizations can navigate the complexities of ISO 13485 implementation, ensuring both compliance and business s... ...more
ISO13485 Certification
December 22, 2025•5 min read
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