We are regulatory compliance specialists
helping therapeutic goods manufacturers, testing laboratories
and biotechnology companies.
IF A REGULATOR WALKED IN TODAY,
ARE YOU PREPARED FOR AN AUDIT?
At Quality Systems Now, we understand the pressure of being audit-ready. That’s why our Compliance Readiness Assessment is designed to help you quickly identify any gaps in your GMP and ISO 13485 compliance.
WHAT WE DO
Quality Systems Now (QSN) is a boutique consulting company.
We specialize in helping therapeutic manufacturers, testing laboratories and associated supporting companies
gain or maintain their GMP manufacturing license or ISO accreditation.
We will help you develop or transform your systems and processes, while ensuring compliance.
Anyone can put a process in place that turns out to be complex to use, or not quite meeting compliance requirements.
It takes knowledge and experience to make things simple for users:
Simple Quality Management Systems
Simple operational processes validated as fit for purpose
Simple study design to support your product registration
Simple procedures and instructions
Integrated and user-friendly
Simple, Compliant... Period!
At QSN, we work with you wherever you are on your compliance or commercialization journey.
We won't complicate things but will advise and support you on your compliance responsibilities and doing things right first time.
WHY WORK WITH US
We often have clients who return to QSN multiple times because of the great experience they have working with us.
QSN consultants are knowledgeable in their niche areas of expertise. They have been in the industry for many years, working with clients, so they have authority and know what works in practice.
We also pride ourselves on being flexible and agile, able to quickly engage and assist clients, wherever they are on their compliance journey.
And we won't over-complicate things, we keep it simple!
We support clients across four core service areas:
OUR FRAMEWORK
We work with all clients using our QSN framework. Whether you need help with all stages or just one or two to meet your goals, this is our roadmap for delivering your project.
Check out our QSN framework below.
SIX PILLARS OF IMPLEMENTATION
As part of the framework Stage 3 - Begin the Transformation, QSN uses the following compliance pillars to help you implement your project.
So, whether you have a new greenfield site, or a documentation project, we understand the wider view and can help you deliver a simple, compliance solution.
SOME OF THE INDUSTRIES WE SUPPORT
PHARMACEUTICAL
MEDICAL DEVICES
BIOTECH
TESTIMONIALS
"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."
Senior Quality & Regulatory Manager
GMP/Medical Devices
"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."
CFO
Biotech
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.
CEO
Biotech/Clinical
"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."
QA Manager
GMP Pharma
"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."
QA Manager
Medical Devices
"The masterclass... was absolutely brilliant, useful, insightful and reminding basic principles in making simpler, easy to understand documents in almost all functions and areas.
QA Manager
GMP Pharma
"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!
Project Manager
Medtech
"QSN have 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."
Operations Manager
Medtech
"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."
Quality Manager
GMP Pharma
Excellent videos, clear, concise and very informative. Kathy is a great source of knowledge and her help and advice is always invaluable for us.
Quality Systems Manager
Medtech
Clear structure, right level of details, up to date information, useful for any medicine manufacturers/sponsors. Catering for all customer needs with the text and video.
Quality Manager
Medtech
The course is providing a very clear and sequential training deck which would aid in learning for new trainees and trainees who are refreshing their knowledge.
Quality Manager
GMP Pharma
Very well structured and presented nicely (as expected from a professional writer)
Scilife Training Attendee
Kathy is a very pleasant and good communicator with efficient style!
Scilife Training Attendee
This was a very clear and informative, to the point, webinar.
Scilife Training Attendee
TRANSFORM YOUR PROCEDURES INTO
USER-FRIENDLY DOCUMENTS USING
PLAIN LANGUAGE
Learn how to eliminate:
Mix-ups, mistakes, high error rates or impacts from unclear, incomplete or incorrect documents
Inefficiency and decreased productivity
Negative impacts during development or manufacturing
Inspection deficiencies that impact time, cost and company reputation.
