Our thank you goes out to Kathy and the Team for the trial and feedback on our profit simulator.
Introduction to Quality Systems Now
Supporting Excellence in Regulatory Compliance
Quality Systems Now is a leading consultancy in the field of GMP and regulatory compliance, providing specialised support to organisations involved in the manufacture and testing of therapeutic goods, biotechnology products, and medical devices. Founded by industry veteran Kathy Connell, the company offers tailored solutions that help clients navigate the often complex regulatory landscape, achieve compliance with national and international standards, and build sustainable quality systems. Whether working with established pharmaceutical manufacturers, early-stage biotech firms, or accredited testing laboratories, Quality Systems Now delivers practical and strategic support designed to meet the highest standards of quality and regulatory integrity. Learn More >>
Expertise in GMP and ISO Standards
One of the key strengths of Quality Systems Now lies in its deep knowledge of Good Manufacturing Practice (GMP) and its integration with ISO quality standards, including ISO 9001 and ISO 13485. The company’s consultants bring hands-on experience across all aspects of pharmaceutical and biotech operations, including manufacturing, quality control, documentation, validation, and inspection readiness. They assist clients in interpreting and applying frameworks such as PIC/S GMP, the Therapeutic Goods Administration (TGA) requirements, and global standards like those of the EMA and FDA.
This expertise ensures that Quality Systems Now can provide both corrective and preventative guidance. For example, during a compliance gap analysis, the team can identify process or documentation weaknesses, then provide actionable plans to correct them—minimising the risk of non-conformities during regulatory inspections.
Tailored Services for Diverse Clients
Quality Systems Now serves a wide range of clients across the regulated life sciences sector. Services are always tailored to the specific size, scope, and maturity of each organisation. Start-ups and early-phase R&D firms might require assistance setting up foundational systems such as Standard Operating Procedures (SOPs), deviation reporting workflows, or training registers. In contrast, established manufacturers may benefit from validation program reviews, internal audit preparation, or CAPA investigations following recent inspections.
Their flexibility allows them to work effectively with:
- Pharmaceutical manufacturers and wholesalers
- Biotechnology research companies
- Medical device firms
- Contract testing laboratories
- Compounding pharmacies
- Cosmetic and complementary medicine producers
Whatever the size or sector, Quality Systems Now adjusts its approach to suit the client’s unique regulatory obligations and operational constraints.
Education Through QSN Academy
Training and capability-building are core components of Quality Systems Now’s mission. Through its educational arm, QSN Academy, the company delivers high-quality GMP training courses aimed at building compliance knowledge across all staff levels. Programs include GMP induction training for new starters, refresher modules for experienced staff, and advanced training in Good Documentation Practices, deviation investigations, and audit preparation.
Courses are available online, onsite, or via live Zoom sessions, making them accessible regardless of location. All QSN Academy training is designed with adult learning principles and includes assessments to ensure competency. These programs help organisations embed quality thinking and empower staff to take ownership of compliance in their daily work. More about Training Courses >>
Proven Methods, Practical Results
Unlike generalist consultants, the team at Quality Systems Now combines technical expertise with a grounded understanding of operational realities. Their approach is built around collaboration, risk awareness, and measurable results. Every engagement is managed systematically—starting with scoping and planning, followed by structured execution and outcome reporting.
For example, a typical GMP system review includes:
- An initial audit against PIC/S GMP or ISO standards
- A written gap analysis report and risk-rated findings
- A roadmap for remediation including documentation updates and training
- Optional hands-on support with implementation
This methodical and transparent workflow helps clients understand what’s required, why it matters, and how to meet the standards in a cost-effective and sustainable way.
Strategic Partnerships
Quality Systems Now doesn’t just serve clients—they build strategic partnerships. They take the time to understand the context of each business, from supply chain complexity to resourcing constraints, and provide advice that is not only compliant but commercially sensible. For instance, in helping a client scale up production, the team might integrate GMP principles into process design while also addressing scheduling efficiency and material control.
Furthermore, they offer guidance beyond compliance, including strategies for new product registration with the TGA, quality agreements with contract manufacturers, or preparation for overseas market entry. In this way, Quality Systems Now helps clients turn regulatory obligations into competitive advantages.
Building a Culture of Quality
A defining principle of Quality Systems Now is its commitment to fostering quality culture. While compliance is essential, the long-term goal is to embed quality into the organisation’s mindset, ensuring that systems are not just followed but understood and valued by staff. This cultural alignment reduces errors, improves patient safety, and builds trust with regulators and customers alike.
To support this, Quality Systems Now offers leadership coaching, QMS maturity assessments, and change management advice, especially during transitions such as mergers, facility upgrades, or product launches.
Conclusion
In the tightly regulated field of therapeutic goods, quality and compliance are non-negotiable. But that doesn’t mean they must be complex, costly, or disruptive. With Quality Systems Now, organisations gain a partner who understands the science, the regulations, and the operational challenges—and who is committed to delivering practical, effective solutions. Through expert consulting, customised training, and a commitment to continuous improvement, Kathy and her team empower companies to meet compliance goals, strengthen internal capability, and ultimately deliver safer, more reliable products to the market.