LATEST NEWS - GMP, ISO & INDUSTRY BLOGS
Advancing a Botanical Drug Product into Phase 2
Advancing a botanical-derived product into clinical development presents a distinctive quality and CMC challenge. Unlike a conventional synthetic drug substance, a botanical-derived product may origin... ...more
Good Manufacturing Practices
October 01, 2026•9 min read
Dealing with audit deficiency remediation
Audit deficiency remediation is the process of identifying the underlying cause of a compliance gap, determining the actions required to correct it, and establishing objective evidence that the correc... ...more
Compliance ,Audit Readiness
September 29, 2026•8 min read
Achieving TGA medical device compliance
For manufacturers, this means integrating regulatory requirements into product development, quality management and operational decision-making. ...more
Compliance
September 25, 2026•8 min read
What is a Compliance Partner program?
A Compliance Partner program provides a structured way to maintain that continuity. It gives an organisation access to specialist support for auditing, system maintenance, regulatory developments and ... ...more
Compliance
September 22, 2026•7 min read
Pharmaceutical Quality System (PQS) explained
A Pharmaceutical Quality System provides the infrastructure that connects individual quality activities into a functioning framework. ...more
Medtech ,QMS
September 17, 2026•8 min read
How do I get a GMP manufacturing licence in Australia?
The TGA licence is ultimately evidence that the manufacturing site has met the applicable regulatory requirements for the authorised scope. ...more
GMP
September 14, 2026•8 min read
ISO 14971 Risk Management 101
A robust ISO 14971 process connects risk management with the technical and quality activities that generate meaningful risk information. ...more
ISO 14971
September 09, 2026•9 min read
Do You Need Help With Your CAPA Backlog?
A corrective and preventive action (CAPA) system is intended to identify the causes of quality problems, correct them effectively, and prevent recurrence. ...more
Compliance
September 07, 2026•7 min read
Outsourced Quality Assurance Pharma
Outsourced quality assurance can provide access to specialist expertise without requiring an organisation to build every capability entirely through permanent internal resources. ...more
Quality Culture
September 02, 2026•10 min read
Writing SOP's people can follow
A procedure may contain technically accurate information, appropriate terminology and all the expected sections, but if users cannot quickly understand what they need to do, when they need to do it, o... ...more
Quality Culture
August 31, 2026•11 min read
Medical Device Site Licensing Made Simple
Our work can include quality system development, gap assessments, audit preparation, procedure development, risk management, validation strategy, supplier controls, CAPA systems, document control, tra... ...more
Medtech
August 26, 2026•8 min read
GMP consultant Australia - What We Do
Quality Systems Now provides GMP consulting support to organisations that need to establish, strengthen, assess or maintain compliant quality systems. Our work focuses on practical implementation ...more
GMP
August 24, 2026•6 min read
Last Chance to Join the Webinar on Writing SOPs
The webinar, Writing SOPs people can actually follow: plain language and AI in practice, takes place on 25 August 2026 at 7:00 PM Brisbane time. ...more
News
August 21, 2026•9 min read
Quality Systems Now – Your Quality Management Maturity (QMM) Consultant
A mature QMS should do more than provide a collection of policies and procedures. It should provide a coherent framework for controlling activities, managing risk, identifying problems, implementing i... ...more
QMS
August 18, 2026•9 min read
Audit Deficiency Remediation
An audit deficiency identifies a gap between expected and observed performance within a quality system. The finding may relate to documentation, procedures, training, data integrity, equipment, facili... ...more
Audit Readiness
August 13, 2026•9 min read
How AI Turns a Process Map and a Compendial Test Method into First-Draft Procedures
When provided with a clearly defined process map and authoritative technical source material such as a compendial test method, AI can generate a structured first draft of a procedure. ...more
AI
August 11, 2026•10 min read
Ensuring GLP-Ready Lab Practices
Laboratories operating in regulated environments must be prepared to demonstrate control over their activities at any time. ...more
Medtech ,Compliance
August 05, 2026•6 min read
Achieving Reduced Audit Findings and Fewer Rework Cycles
Achieving reduced audit findings and fewer rework cycles requires a proactive approach to quality management. ...more
Audit Readiness
August 03, 2026•6 min read
Raw Material Sourcing, Batch Consistency, and CMO Oversight
By implementing robust supplier qualification processes, maintaining appropriate manufacturing oversight, controlling changes and strengthening documentation practices, organisations can reduce supply... ...more
Quality Culture
July 30, 2026•6 min read
Without Systems in Place Early, Documentation Is Fragmented, Rework Is Frequent, and the Risk of Non-Compliance Increases
Without systems in place early, documentation becomes fragmented, rework becomes more frequent and the risk of non-compliance increases. These challenges can create unnecessary delays, increase costs ... ...more
Compliance
July 27, 2026
How to Avoid Delays in Market Entry
ISO 13485 establishes requirements for a quality management system covering design and development, supplier management, document control, corrective action, training, management review and continual ... ...more
ISO13485 Certification
July 22, 2026•6 min read
Software as a Medical Device (SaMD) Start Up Case Study
Quality Systems Now provided targeted support to identify compliance gaps, strengthen documentation, improve validation activities, prepare personnel through structured training and conduct independen... ...more
Medtech
July 20, 2026•5 min read
Why Big Pharma QMS Does Not Suit Your Startup
The transition from research to regulated manufacturing requires careful planning. A startup needs a QMS that reflects its current activities while preparing for future expansion. ...more
QMS
July 15, 2026•6 min read
Is Your Organisation Stuck Between R&D and GMP?
The transition from R&D to GMP does not need to represent a conflict between innovation and compliance. The most successful organisations recognise that quality systems support scientific progress. ...more
GMP
July 13, 2026•5 min read
Resources: QSN Academy · Blog · Webinars · eBooks · Scorecards · Book
Connect: LinkedIn (QSN) · LinkedIn (QSN Academy) · Linkedin (Dr Kathy Walsh) · Facebook · Email at info@qualitysystemsnow.com.au · Contact Us
Legal: Privacy Policy · Terms & Conditions · Complaints Procedure · Sitemap · QSN ABN 42 621 334 754