TESTIMONIALS
From compliance to confidence!
Discover how QSN has guided organizations across pharma, medtech, biotech, and labs to success.
"Our company relied heavily on Kathy and her team at QSN to build a GxP QMS from scratch, including supporting eQMS configuration, validation, SOP detail and process development, and supported our TGA audit... I would highly recommend Kathy and her team at QSN to any pharma start-up or company."
"Having worked with Kathy for many years, I can speak from first-hand experience of the exceptional quality of her work. Her honest, practical approach, and collaborative way of working is what makes her stand out from the rest. The improvements she identified and helped implement to the company's internal audit program resulted in an ISO13485 TGA A1 audit rating. Kathy's valuable service, knowledge and expertise is second to none. I highly recommend her and the QSN team to any company who wants a positive audit outcome."
"Kathy did an extraordinary job leading our ISO17025 accreditation of our company in record time. Since the first day Kathy became an extension of our team and trained the staff not only to set up the quality systems but also so make sure they would own the systems that we were implementing. Kathy led the audit when the assessors were on site and coordinated responses post-audit, with very positive auditor feedback... I highly recommend Kathy to any company interested in the accreditation process, she will maximize the chances of success."
The QSN team helped our company implement a QMS from scratch, and guided our team through accreditation in record time. Our business has been able to grow and access more clinical studies because of QSN’s expertise and Quality guidance.
"QSN helped with our audit readiness - their willingness to provide support and share their knowledge and experience with the team was the best thing about their service."
"I personally wanted to say thanks to you and the rest of the QSN team for all the QA and QMS support as we have now received notification that we have passed our ISO 13485 Stage 2 Audit."
"The masterclass... was absolutely brilliant, useful, insightful and reminding basic principles in making simpler, easy to understand documents in almost all functions and areas.
"The best thing about QSN is their knowledge, experience and they're just a great lot of people to work with. They know what they're doing yet they can be humble and always professional on their approach on things!"
"QSN has a can-do attitude with positive mindset and proactive approach to problem solving. This was a great asset in helping us to focus on solutions and accomplish the tasks at hand."
PAST PROJECTS
1. Reusable Medical Device Reprocessing – Greenfield Site Project (Victoria)
Standards: ISO13485, AS 4187, ISO9001
Key Deliverables: Transition to ISO13485, QMS, validation and early-stage development, QA, auditing
Project Summary:
QSN provided support to this international company who developed a bespoke process, currently first in the world, for reprocessing and sterilizing their highly-sensitive medical devices used in surgery. The company had developed a pilot process based on AS 4187 requirements. QSN assisted the company with the following services:
- Supported the development and trial of a pilot facility – internal workshops, process mapping, integration with the wider business processes (ISO9001 compliant), product/material/personnel flows, Gemba walks and process reviews.
- Ensured that the end-to-end reprocessing process was compliant and met IFU requirements for all medical devices.
- Provided Quality and compliance support to the project team and business QA/RA team.
- Developed protocols for early-stage end-to-end studies as a precursor to validation, transport and logistics studies, process validation and equipment validation.
- Supported sterilization validation as the QA representative.
- Developed the new greenfield facility user requirements specification prior to architectural planning and fit out.
- Developed the facility environmental monitoring program.
- Completed Gemba walks and internal audits of the new greenfield facility.
- Developed the greenfield facility QMS (~200 docs), including numerous bespoke processes, aligned with ISO13485, including batch instructions, batch records, packaging and labelling requirements, procedures, instructions, forms etc.
- Completed facility vendor qualifications as the QA representative.
- Managed facility QMS integration with the wider business QMS – change controls, document approvals and routing.
- Supported audit readiness for ISO13485 accreditation.
- Performs ongoing mock/internal audits to ISO13485 prior to re-accreditation/licensing by the notified body.
2. GMP Cannabis Manufacturer – Greenfield Site Project (Victoria)
Standards: PIC/S GMP, TGO 93, Office of Drug Control (ODC)
Key Deliverables: QMS implementation, validation, production, QA, auditing, training, eQMS implementation
Project Summary:
A medicinal cannabis manufacturer, as a subsidiary of an international company, developed a greenfield GMP manufacturing site. They imported fresh cannabis from overseas cultivators. Their manufacturing process included drying, milling, extracting, winterization, fill and finish. They had developed a commercial scale, in-house extraction process using super-critical CO2. Finished product presentations were bulk in oil (for compounding pharmacies), vapes, bottled oil preparations, and gel caps. QSN assisted the company with the following services:
- Develop QMS documents (~200 docs) from scratch to address GMP, TGO 93 and ODC requirements.
- Support the development of risk assessments for the end-to-end manufacturing process and supply chain, particularly for different cultivators and international supply pathways.
- QA representative support for all QMS and QA activities.
- Complete vendor qualifications.
- Support for the validation program, including developing the VMP and key protocols for equipment, process, and cleaning in production.
- Support for test method validation, developing testing specifications, equipment validation and laboratory processes.
- Support the implementation of an eQMS, including workflow customization, executing test scripts with the vendor, validation reporting, developing GMP templates for the system, planning cutover of data and documents into the system etc.
- Stability program development (initial) and review (in operation).
- Audit readiness activities and on-site audit support during the TGA inspections.
- Develop numerous bespoke processes to manage manual inwards goods, vault storage, material storage, and retention storage within a small facility.
- Support for ongoing PQRs across product families.
- Initial and ongoing training in GMP refresher, auditing, PQRs, audit readiness, plain language document writing, GDocP.
3. Testing Laboratory ISO17025 Accreditation Project (Victoria)
Standards: ISO17025
Key Deliverables: Transition to ISO17025 accreditation, QMS, QA, training, audit readiness and audit support
Project Summary:
A laboratory specializing in PBMC, cryopreservation, ELISA and Multiplex techniques supporting international clinical trial testing required NATA accreditation in ISO17025. They had established a small laboratory with some systems and processes in place but did not have a QMS. QSN assisted the company with the following services:
- Developed a QMS from scratch (~100 docs), including developing laboratory processes with SMEs.
- Established a chain of custody process within the laboratory to manage incoming samples and subsequent test samples.
- Supported equipment validation, including cold storage, incubators and key instruments.
- Established processes and systems for data integrity of laboratory data and results, including checking and approval/release.
- Supported temperature mapping of temperature storages, including protocol development and reporting.
- Trained the company in Good Documentation Practices (GDocP) for laboratory
- Trained the company in ISO17025 standard.
- Trained the company in all QMS procedures (read & understand).
- QA Representative for the laboratory for ~ 2 years, managing all aspects of the QMS, training, changes, deviations and nonconformances, internal audits etc.
- Audit readiness support prior to inspections.
- Managed the NATA audit inspection on behalf of the company, including leading the company audit activities during the inspection and responding to deficiencies.
- Ongoing QA and QMS support once accredited.
4. New Sponsor of a Medicine – GMP and GCP Support (International)
Standards: PIC/s and FDA GMPs, ICH GCP
Key Deliverables: Implement a QMS, general QA support, support for transition from development activities to GMP compliance, client training in quality systems
Project Summary:
A start-up sponsor developing a new oral dose medicine engaged QSN to establish a fit for purpose QMS and client-specific processes to support clinical trials, ongoing product development and registration. QSN supported the company with the following services:
- Design and implementation of a complete QMS (~150 documents) tailored to a virtual sponsor model with outsourced GMP activities (API manufacturing, finished product manufacture, and analytical testing).
- Authored QMS and client specific documents in collaboration with client SMEs to ensure coverage of both GMP and GCP requirements, enabling effective oversight of sponsor obligations during clinical trials.
- Developed a 21CFR Part 11 compliant document management and approval framework suitable for a small virtual sponsor company, providing secure, audit-ready records and streamlined approval processes.
- Established a SharePoint architecture to support controlled GMP document management, delivering a scalable, user-friendly platform that facilitated compliance and efficient document control.
- Supported GMP batch readiness with transition of documentation and systems from product development to GMP, including collation and review of historical batch manufacturing records, vendor change controls, specifications, vendor qualifications and quality agreements etc., resulting in a complete and inspection-ready documentation package.
- Managed general QMS administration and QA oversight activities on behalf of the sponsor, ensuring continuous compliance, timely approvals, and effective monitoring of outsourced activities.
- Provided QA and product development support for the stability program and regulatory submissions considering a complex, international supply chain.
(QSN has successfully supported multiple sponsor organisations in establishing QMS frameworks, implementing QA processes, and providing tailored training. Please contact us if you would like further examples.)
5. Manufacturer of CAR T-Cell for Cancer Cell Therapy – eQMS Support (International)
Standards: PIC/S GMP, GAMP
Key Deliverables: Transition to an eQMS, computer system validation, QA
Project Summary:
A GMP start-up manufacturer wanted to automate their QMS and release processes to reduce the time required to provide cell therapy to individual patients. QSN provided the following services:
- Gap assessment of QMS documents and eQMS vendor validation documents to provide a transition plan including list of document changes and validation gaps.
- Provided validation support for eQMS implementation.
- QA Representative for validation activities.
- Support for document changes needed with adopting the eQMS workflows and addressing doc numbering changes.
6. Reusable Medical Device Reprocessing – Greenfield Site (Victoria)
Standards: AS4187, ISO9001
Key Deliverables: QMS, eQMS implementation
Project Summary:
A reusable medical device reprocessing company was establishing multiple sites across Australia for routine reprocessing of medical devices. The company required assistance to develop their QMS and implement eQMS software, intended to be used across multiple sites, once established. QSN provided support to the company with the following services:
- Completed a gap analysis and review of existing procedural documentation.
- Developed a document register for the new QMS.
- Drafted QMS documents with SMEs.
- Multiple Gemba walks through the operational areas to map current processes.
- Reviewed eQMS solution for compliance and suitability.
- Reviewed eQMS vendor validation and installation documents.
- Supported QA activities as requested.
7. Pharmaceutical Manufacturer – Technical Writing and SME Support for New Site (Victoria)
Standards: PIC/S GMP
Key Deliverables: QMS technical writing, Cross Contamination Strategy (CCS) development, SME technical support
Project Summary:
A large multi-national pharmaceutical manufacturer of aseptic medicines established a new facility and required support to tailor iQMS and technical documentation in readiness for inspection for TGA GMP site licencing. Starting documents from other established sites were available but required detailed amendment to reflect site-specific processes, local operations, and regulatory expectations. QSN partnered with the client to deliver the following services:
- Technical writing and collaboration with SMEs over ~18 months, producing and refining QMS documents across engineering, facility management (e.g., cleaning, gowning, waste management, utilities), and warehouse/supply chain operations, which ensured site-specific procedures were inspection-ready and fully aligned with GMP expectations.
- Process mapping and process design workshops with SMEs to ensure procedures aligned with site practices and supported operational readiness.
- Drafting the site Cross Contamination Strategy (CCS) providing a robust, compliant framework that addressed regulatory expectations and enabled the site to clearly demonstrate contamination prevention measures during inspections.
- Providing SME support for the introduction of new manufacturing components, specifically regarding the extractables and leachables (E&L) strategy and review of supplier documentation to ensure compliance, reduced regulatory risk, and confident approval of new materials.
(QSN has successfully supported numerous pharmaceutical manufacturers in developing technical documentation and QMS frameworks tailored to new and established facilities. Please contact us for further examples).
8. SaMD and IVD Medical Device Start-Up – ISO13485 Support (Queensland)
Standards: ISO13485, ISO14971, IEC 62304, ISO/TR 80002-2
Key Deliverables: QMS, validation, training, audit support
Project Summary:
An IVD medical device company developed software to review patient medical results from their IVD kit. The company required support prior to gaining their ISO13485 accreditation, and ongoing compliance support. QSN provided support to the company with the following services:
- ISO13485 gap assessment of current QMS with recommendations and risks.
- Review of new QMS procedures developed by SMEs.
- Review and support of the validation program.
- Training in ISO13485, ISO14971, IEC 62304 and GDocP.
- Mock ISO13485 inspection prior to notified body inspection.
- Ongoing annual mock inspections for audit readiness prior to notified body inspection.
9. New Medical Device Manufacturer – ISO13485 Transition and Accreditation Support (Victoria)
Standards: ISO13485, ISO14971, ANZ standards specific to device
Key Deliverables: QMS, training, QA, audit support, facility/manufacturing, product development, regulatory affairs
Project Summary:
A manufacturer transitioning into medical device manufacture (during COVID) required support to establish their facility, products, QMS and personnel ready for ISO13485 inspection by a notified body. QSN supported the company with the following services:
- Developed a QMS, customized to the manufacturer’s processes, products and systems (~200 docs).
- Established a starting material specification and testing process, and provided support for external testing of materials prior to release for use in Production.
- Established a compliant inwards goods receipt process that inspected, labelled and tracked materials in the warehouse (manual system).
- Provided support to the QA Manager and Production Manager for compliant. manufacturing activities – personnel/material/product flows, cleanroom layout and appropriate qualification requirements, cleanroom gowning and cleaning process.
- Provided support for release for supply and final inspection – new process to the company.
- Reviewed validation protocols drafted by SMEs.
- Trained key personnel from QA and Production in gowning and cleaning requirements.
- Trained the company in ISO13485.
- Drafted study reports to support the technical file.
- Collated or drafted documentation for the STED in collaboration with Regulatory Affairs
- Audit readiness activities.
- Audit support during two (2) notified body inspections.
10. GMP Cannabis Manufacturer – QMS and GMP Support (New South Wales)
Standards: PIC/S GMP, TGO 93, ODC
Key Deliverables: QMS integration, validation review, training, Product Quality Review (PQR), audit support, regulation interpretation, stability program optimisation
Project Summary:
A medicinal cannabis cultivator and manufacturer required expert support to integrate a second site into their existing QMS and validation program and manage production/facility upgrades for GMP compliance (e.g. cleanroom qualification, HVAC, material and product flows etc.). QSN provided support to the company with the following services:
- Reviewed of QMS frameworks from both sites and developed a consolidation plan to harmonise and leverage common processes, resulting in a streamlined, integrated quality system across the organisation.
- Reviewed and refined procedures drafted by SMEs to ensure alignment with GMP and operational practices, improving compliance and ensuring procedures were practical for day-to-day use.
- Provided oversight and support for the validation program, including drafting and reviewing protocols for key systems, ensuring validation packages were robust, compliant, and ready for regulatory review.
- Conducted on-site Gemba walks to identify gaps and provide actionable recommendations, enabling timely remediation and strengthening GMP readiness.
- Delivered hands-on GMP support and guidance for QA Managers from both sites, building internal capability and improving consistency of quality oversight.
- Performed independent review of PQRs ensuring accuracy, completeness, and inspection readiness.
- Provided audit readiness and back room support during two successful TGA licensing inspections, helping the sites to navigate regulator queries and demonstrate compliance.
- Conducted stability program gap assessment across all products (flower, oils, vapes, etc.), including benchmarking against GMP requirements and providing risk-based recommendations for ongoing studies tailored to the botanical profile of cannabis products.
- Delivered targeted training in auditing, PQR preparation, authorised person/release for supply responsibilities, GMP refreshers, as well as routine onboarding training for new staff and role transitions, improving workforce competence and sustaining compliance across changing roles.
- Provided ongoing regulatory/compliance advice including navigating different regulations across the international supply chain and evolving requirements.
- Advised on regulatory considerations for product development, supporting compliant innovation and reducing the risk of delays in bringing products to market.
(QSN has successfully supported multiple medicinal cannabis manufacturers in establishing GMP-compliant QMS frameworks, developing technical documentation, developing risk-based stability strategies and addressing the unique regulatory and product challenges of medicinal cannabis. Please contact us for further examples.)
11. IVD and SaMD Medical Device Company – ISO13485 Transition Support (Victoria)
Standards: ISO13485, ISO14971
Key Deliverables: QMS, design and development, validation, audit support, training
Project Summary:
An IVD medical device company required support to transition to the updated version of ISO13485. Their IVD included a kit and software for the interpretation of results. They were accredited using the TGA, rather than a notified body. Consequently, the inspection by the regulator was expected to be thorough. QSN assisted the company with the following services:
- Completed a gap analysis to the updated version of ISO13485
- Developed a transition plan to the updated standard.
- Developed the design and development process with SMEs (process gap).
- Ensured the technical file/STED was updated.
- Developed a software version control and change control process.
- Reviewed and developed multiple QMS processes to close gaps.
- Completed quality activities as a QA Representative.
- Completed audit readiness preparations with SMEs and QA.
- Represented the company as the QA Representative, alongside the QA Manager, during TGA inspection.
- Supported closing minor deficiencies.
- Trained the company in ISO13485, clause-by-clause training in design and development requirements and systems, and data integrity and GDocP.
- Lead the development of material qualification, vendor qualification and material criticality assessments.
- Supported the end-to-end risk assessment of the manufacturing and distribution activities.
- Trained the company in ISO14971.
12. Pharmaceutical Manufacturer – Global SAP Software Implementation Project (International)
Standards: PIC/S, EU and FDA GMPs
Key Deliverables: QMS, Training, Project Management
Project Summary:
An international pharmaceutical manufacturer of aseptic medicines was completing a global implementation of SAP. Rollout was Northern Hemisphere followed by Southern Hemisphere. All Business as Usual needed to be maintained according to routine manufacturing schedules. QSN were included in the project team, responsible for QMS and training delivery. QSN supported the company with the following services (~18 months):
- Gap analysis of current site QMS documents impacted by the change.
- Participated in project team planning and reporting to the project manager and project board.
- Supported and tracked UK QMS document changes for Northern Hemisphere Go-Live (from the UK and from AU).
- Trained the project team on process mapping and identifying changes.
- Engaged with local stream leaders to process map As Is and To Be changes.
- Supported documentation drafting by stream teams.
- Developed site training packages for each user access level.
- Supported project change management activities.
- Supported the delivery of site training by stream leads.
- Supported Go-Live and post go-live activities.
13. Sponsor, Importer and Wholesaler of Radiopharmaceuticals – GMP Support (New South Wales)
Standards: PIC/s PE 009, including Annex 3
Key Deliverables: QMS gap assessment and integration
Project Summary:
A sponsor, importer and wholesaler of non-scheduled prescription radiopharmaceutical products, including Section 19a and Special Access Scheme (SAS) consent products, engaged QSN to assess, remediate and complete training activities for their QMS to meet the minimum TGA requirements. QSN supported the company with the following services:
- Completed a gap analysis of existing QMS documentation against PIC/s requirements.
- Created or updated QMS documents (~55 docs) and integrated these within the existing QMS.
- Engaged with SMEs to develop and review QMS documents.
- Delivered training for all new processes.