LATEST NEWS
Software as a Medical Device (SaaS / SaMD)
Software now performs functions that were historically limited to physical medical devices, laboratory instrumentation, or direct clinical assessment. ...more
News
June 04, 2026•6 min read
Commercial pharmaceutical manufacturing (licensed facilities)
Commercial pharmaceutical manufacturing within licensed facilities operates under highly controlled regulatory frameworks designed to ensure the safety, quality, efficacy, and consistency of therapeut... ...more
Compliance
June 02, 2026•6 min read
Inspection readiness isn't a one-off activity - it's a system
Inspection readiness is not an event-based exercise. It is the outcome of an operational system functioning correctly every day. ...more
Audit Readiness
May 27, 2026•6 min read
Pharmaceutical Quality Systems and Your Business Success
Pharmaceutical quality systems are directly connected to long-term business sustainability. ...more
QMS
May 25, 2026•6 min read
Introduction to Software and AI in Regulated Medical Devices
Software and AI medical device compliance represents one of the most complex and rapidly evolving areas of regulatory science. It requires integration of traditional quality management principles with... ...more
Medtech
May 21, 2026•6 min read
Compliance Priorities 2027
The compliance priorities for 2027 reflect a clear shift toward integrated, data-driven, and scientifically structured regulatory frameworks. ...more
Compliance
May 18, 2026•6 min read
The TGA Compliance Principles
The TGA compliance principles are grounded in scientific rigor, risk-based thinking, and lifecycle control of therapeutic goods. ...more
Therapeutic Goods Administration
May 13, 2026•6 min read
A Case Study of ISO 13485 Transition Support
The ISO 13485 transition project for the IVD manufacturer demonstrates a comprehensive approach to quality system enhancement within a regulated medical device environment. ...more
ISO13485 Certification
May 11, 2026•7 min read
Quality that grows with your science
Quality that grows with your science is not a conceptual ideal. It is a functional requirement. ...more
Quality Culture
May 06, 2026•6 min read
GLP/GCP/GMP Expectations Explained by phase
GLP, GCP, and GMP represent a structured progression of regulatory expectations aligned ...more
Quality Culture ,GMP
May 04, 2026•5 min read
Can You pass ISO 13485 certification?
ISO 13485 certification is not just a regulatory requirement. It is a validation of an organisation ...more
ISO13485 Certification
April 30, 2026•6 min read
Evaluate your facility’s quality system, validation programs, and team readiness
Evaluating a facility’s quality system, validation programs, and team readiness is fundamental ...more
Compliance
April 28, 2026•6 min read
Common Regulatory Challenges for Therapeutic Goods Manufacturers
Therapeutic goods manufacturers face a complex and evolving regulatory landscape, with challenges spanning quality management, data integrity, validation, and supply chain oversight. While these chall... ...more
Therapeutic Goods Administration
April 22, 2026•6 min read
Case Study of an ISO ISO17025 Accreditation Project
While technical capability is essential, it is not sufficient on its own. A comprehensive and integrated QMS is required to provide the visibility, control, and consistency necessary for compliance. ...more
ISO 17025
April 20, 2026•6 min read
Surge in Data Integrity Findings in GxP Inspections
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... ...more
News
April 15, 2026•6 min read
The Visibility Problem in Regulated Environments
In GxP-regulated environments, the ability to see clearly is a prerequisite for effective action. Without sufficient visibility, even well-designed systems and highly capable teams are vulnerable to h... ...more
QMS
April 13, 2026•6 min read
Master the essentials of data integrity and GDocP
Mastering data integrity and Good Documentation Practice is essential for maintaining regulatory compliance and ensuring scientific validity in therapeutic goods development and manufacturing. These p... ...more
Quality Culture ,GMP
April 08, 2026•5 min read
We help you choose the right quality and regulatory actions at the right stage
The selection of appropriate quality and regulatory actions at the correct stage of product development is a critical determinant of success in regulated life science industries. Misalignment between ... ...more
Quality Culture ,Compliance
April 06, 2026•6 min read
Challenges of Early Stage Sponsors and Manufacturers for Medicines
Early stage sponsors and manufacturers of medicinal products operate within a complex and evolving environment where scientific innovation must be balanced with regulatory compliance and operational c... ...more
QMS ,Compliance
April 01, 2026•6 min read
CAR T-Cell for Cancer Cell Therapy – eQMS Support
The CAR T-cell therapy eQMS implementation project undertaken by Quality Systems Now demonstrated the critical role of integrated quality systems in supporting advanced therapeutic manufacturing envir... ...more
Quality Culture ,QMS
March 30, 2026•7 min read
Lab Notebooks, Shared Drives, eQMS — What’s “Good Enough”
By implementing structured, risk-based, and auditable recordkeeping practices, therapeutic goods manufacturers, testing laboratories, and biotechnology companies can confidently demonstrate that their... ...more
Compliance
March 24, 2026•5 min read
Data Integrity and Good Documentation Practices
Data integrity and good documentation practices form the backbone of compliance and scientific rigor in GxP-regulated industries. By adhering to principles such as ALCOA+, ensuring traceable and accur... ...more
Quality Culture ,Compliance
March 22, 2026•5 min read
Showing Maturity Without Overselling
Showing maturity without overselling is a strategic imperative for organisations operating under GxP and regulatory compliance frameworks. Evidence-based demonstration, transparent communication, incr... ...more
GMP
March 18, 2026•5 min read
Build Strong Foundations Before You Scale
Scaling in GxP-regulated environments is a complex and high-risk undertaking that requires a strong foundational framework. A robust Quality Management System, validated processes, reliable data pract... ...more
Quality Culture
March 16, 2026•6 min read