FAQs
At Quality Systems Now, we believe in transparency, clarity, and collaboration from the very first conversation. Below you’ll find answers to the most common questions about what we do and how we work so you know exactly what to expect when partnering with QSN.
GMP and GxP Compliance
What is GxP compliance?
GxP is the collective term for the quality guidelines and regulations — GLP, GCP and GMP — that apply across the life sciences, from laboratory testing through clinical trials to manufacturing. QSN helps companies meet GxP requirements without over-engineering their systems.
How do I get a GMP manufacturing licence in Australia?
You'll need to demonstrate that your facilities, systems, documentation, and processes meet TGA GMP requirements, usually confirmed through an on-site inspection. QSN supports the full licensing journey — gap assessment, documentation, system implementation, and inspection readiness.
What's the difference between GMP, GLP and GCP?
GMP (Good Manufacturing Practice) applies to manufacturing, GLP (Good Laboratory Practice) applies to non-clinical laboratory testing, and GCP (Good Clinical Practice) applies to clinical trials. Many companies need to satisfy more than one standard as they move from R&D through to commercialisation, and QSN provides phase-appropriate support across all three.
Who regulates GMP compliance in Australia?
The Therapeutic Goods Administration (TGA) regulates GMP compliance for medicines and manufacturing in Australia, alongside equivalent international frameworks (FDA, EU GMP) for companies operating or exporting overseas. QSN helps clients navigate both local and international regulatory expectations.
PQS and QMS
What is a Pharmaceutical Quality System (PQS)?
A PQS is the overarching quality management framework that governs how a pharmaceutical or biotech company controls its processes, documentation, and product quality. QSN helps build PQS/QMS frameworks that are fit-for-purpose for your business stage. A Quality Management System (QMS) is the equivalent system used for ISO standards.
How do I set up a QMS for a medical device company?
This typically starts with a gap assessment against ISO 13485 and relevant regulatory requirements, followed by building out core procedures, records, and controls. QSN supports the end-to-end setup, tailored to your product risk class and business stage.
What documents do I need for a QMS or PQS?
Your PQS or QMS must meet the requirements of the relevant regulations for your product, type of registration, industry and country. At minimum, most PQS/QMS frameworks require a quality manual, core SOPs (document control, CAPA, change control, training, supplier management etc), records and forms, and risk management documentation. The exact set depends on your industry, regulatory pathway, and business stage. Sponsors typically require fewer procedural documents compared to manufacturers. Your PQS/QMS should describe all processes that your company uses to 'do the things that you do'.
Do startups need a full PQS/QMS from day one?
Not usually. QSN's approach is phase-appropriate — early-stage companies typically need a lighter, scalable system that can grow with the business, rather than a fully mature PQS/QMS built for commercial-scale manufacturing. Clinical biotechs and early-stage startups need some systems to be full GMP, and others to have flexibility, depending on the stage of investigational medicine.
What's a phase-appropriate quality system?
It's a QMS or PQS scaled to match your company's actual stage of regulatory development — avoiding both under-engineering (missing compliance requirements) and over-engineering (unnecessary complexity and cost). This is a core part of QSN's consulting philosophy. For example, investigational medicines, clinical development moves through Good Laboratory Practice (non-clinical), Good Clinical Practice and Good Manufacturing Practice.
ISO Accreditation
How do I get ISO 13485 certified?
The process involves a gap assessment against the standard, building out your QMS documentation and controls, implementing them in practice, ensuring your operations are documented, equipment and processes are validated and meet the requirement of ISO13485, training your personnel, and passing a certification audit from an accredited body. QSN supports each stage, from initial assessment through to audit readiness.
What is ISO 17025 accreditation for?
ISO 17025 is the international standard for testing and calibration laboratory competence, covering technical competence, equipment, and quality management. QSN helps testing laboratories prepare for and maintain ISO 17025 accreditation.
What's the difference between ISO 9001 and ISO 13485?
ISO 9001 is a general quality management standard applicable across industries, while ISO 13485 is specific to medical device quality management and includes additional regulatory and risk-management requirements. Some companies hold both, depending on their product scope.
Auditing and Audit Readiness
How do I prepare for a GMP audit?
Preparation typically involves reviewing your PQS/QMS documentation, your operations, equipment and facility against current requirements, running mock inspections, training staff, and closing any identified gaps ahead of time. QSN offers audit readiness reviews, consulting support and mock inspections tailored to your site.
What is a mock inspection?
A mock inspection simulates a real regulatory inspection, testing your systems, documentation, and staff readiness in a low-stakes setting so gaps can be identified and fixed before the real thing. QSN conducts mock inspections as part of our audit readiness services.
What happens during a TGA inspection?
A TGA inspection typically involves auditors reviewing your facilities, PQS documentation, records, validation studies and product manufacturing, and interviewing staff to confirm compliance with GMP requirements. QSN can help you prepare for and manage the inspection process, train personnel in audit readiness and hosting an audit, and responding to findings.
How do I respond to audit findings?
Audit findings are usually addressed through a formal CAPA (Corrective and Preventive Action) plan that identifies root cause, corrective actions, and preventive measures with defined timelines. QSN can help design your CAPA response and quality improvement plans.
What is a CAPA plan?
CAPA stands for Corrective and Preventive Action — a structured process for investigating quality issues or audit findings, fixing the immediate problem, and preventing recurrence. It's a core element of all PQS/QMS frameworks and a common focus area during inspections.
Clinical Trails and Product Development
What compliance is needed to run a clinical trial in Australia?
Clinical trials in Australia must meet Good Clinical Practice (GCP) requirements, along with TGA and ethics committee approvals depending on the trial pathway. QSN provides support to clinical biotechs across some parts of CMC, QA and developing a phase-appropriate PQS.
How do I transition from R&D to GMP manufacturing?
This transition involves scaling up systems, documentation, and validation from a research setting to a compliant manufacturing environment, without over-building for your current stage. QSN specialises in helping emerging life-science companies bridge exactly this gap.
Training
Where can I get GMP training?
Training in the GMP regulations is paramount for your personnel to take control of your PQS, systems and processes from day one and before site licensing. QSN offers a range of GMP training as part of our services, delivered both through public training sessions and tailored in-house programs for your team.
Is there ISO 13485 training available online?
ISO 13485 training is required to demonstrate that your personnel are able to operate compliantly according to the standard and the regulatory requirements. QSN offers both public and customised training programs covering ISO 13485 and related standards, including ISO14971. Check out https://qsnacademy.com for our training courses.
What is auditor training?
Auditor training equips staff to conduct internal or supplier audits competently, covering audit planning, technique, evidence-gathering, and reporting against relevant standards. QSN provides auditor training tailored to GxP and ISO frameworks.
Working With Us
How does QSN work with clients?
Our process is structured, transparent, and designed to make compliance easy. We begin with a complimentary Meet & Greet session to understand your needs, then prepare a tailored proposal outlining deliverables, timelines, and cost. The proposal serves as our Statement of Work (SOW). Once the proposal is approved and the initial deposit is received, QSN sets up project systems and begins work according to the agreed schedule. If a detailed SOW or project plan is required, this will be scoped as a deliverable within the project and completed once the proposal is approved.
What happens during the Meet & Greet?
The Meet & Greet is an informal discussion with one of our Principal Consultants to understand your business stage, regulatory obligations, and project priorities. It helps ensure your proposal is accurate, phase-appropriate, and aligned with your goals — whether you’re preparing for GMP licensing, ISO accreditation, or an upcoming audit.
What if we’re not sure exactly what we need?
That’s very common. Many organisations discover through discussion that their needs differ from what they initially expected. We can start with a short Discovery or Gap Assessment proposal to confirm what’s required, identify risks, and develop a clear roadmap before moving to an implementation proposal.
When do we start paying for QSN services?
Once your proposal is approved by your decision-maker and returned to us, QSN issues an initial deposit invoice which is payable before work begins. Activities are scheduled with you once payment is received. Remaining work is invoiced fortnightly in arrears based on actual hours worked or milestone completion, as outlined in your proposal.
What if we need internal approval before signing?
We understand that decision-making often involves multiple stakeholders. We can provide a short Executive Summary video presentation to help you brief decision-makers on the project’s objectives, compliance benefits, and cost justification.
Can we adjust the proposal scope or budget?
Yes. We understand every business has constraints. If the proposed scope exceeds your current budget or capacity, QSN can adjust priorities, phase the project, or deliver in modular stages to align with your needs and funding cycle.
When will QSN start the project?
Once the proposal is approved and deposit payment received, QSN will confirm the project start date with you. Consultants are usually available at short notice. Work is typically performed remotely or onsite as required, within your normal business hours.
How does QSN ensure project quality and confidentiality?
All QSN consultants follow our internal project management and quality review processes. We maintain strict confidentiality and are happy to sign a client-specific Non-Disclosure Agreement (NDA) if required. Our consultants are fully insured with professional indemnity and public liability coverage.
What do we need to provide for QSN to get started?
We’ll need timely access to relevant staff, documents, systems, and training for site safety or company induction. Prompt feedback on document reviews is essential to keep the project on track. We aim to finalise documents within two client review cycles to avoid unnecessary delays.
What if the project scope or timelines change?
We understand that priorities can shift. Any changes to the agreed scope or timeline will be discussed and approved in writing before proceeding. If your project is placed on hold for more than six weeks without notice, QSN may invoice for partial costs incurred and treat the project as terminated per our proposal terms.
What if we need to terminate or extend the project?
You can halt or extend a project at any time with written notice (minimum five business days). QSN will only invoice for work completed to date. If additional work is required, a formal scope extension or new proposal will be prepared.
What industries and standards does QSN support?
We work with clients across the pharmaceutical, medical device, biotechnology, and laboratory sectors, specialising in GxP (GLP, GCP, GMP), ISO 13485, ISO 17025, ISO 9001, and related regulatory frameworks including TGA, FDA, and EU requirements.
What kind of guarantees does QSN offer?
QSN guarantees that all deliverables meet current regulatory expectations and are tailored to your business stage. We provide fit-for-purpose, phase-appropriate systems that achieve compliance efficiently without unnecessary complexity.
How does QSN ensure projects stay on time and within budget?
Each project includes defined deliverables, milestones, and reporting. We maintain clear communication and provide progress updates as required. Any variations to scope or cost are always agreed in writing before implementation.
What happens after the project is completed?
We offer handover, training, and post-project support as needed. Many clients choose to continue with QSN through our Compliance Partner or Compliance 4 Life programs for ongoing support, internal audits, and system maintenance.
Can you help with our next audit or inspection?
Absolutely. QSN offers audit readiness reviews, mock inspections, and audit response assistance. We can also help you design your CAPA and quality improvement plans to address any findings efficiently.