QAIRC helps businesses realize their full quality potential
QAIRC - Quality Assurance, Inspection Readiness, Consulting.
Bringing order to processes, embracing efficiencies, helping you to recognize and manage risk, and driving inspection readiness.
A no-nonsense, jargon-free approach that makes it easy for your team to embrace the advantages of a quality culture. QAIRC’s leadership have a long ans successful quality history in both, bringing new products to market and in rectifying quality system errors.
Untangle your standards (SOPs)
We can help you bring order to you difficult to follow, messy and inefficient SOPs, while ensuring they are compliant with GxP regulations* and focus on users needs:
Putting you back In control of your business.
Stopping things falling through the cracks.
Improving your staffs adherence.
Enhancing your ability to measure and improve.
Reducing costly errors and delays.
Improving your teamwork, communication and bottom line.
*The most common 483’s issued by FDA in 2023 relate to SOP management and adherance.
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Embrace your quality cycle
With SOPs as the backbone of your quality organization. We can help with your day to day, providing a correctly scaled solution:
Defining your Quality Management System
Understanding and managing your risks, investigating challenges
Planning and tracking improvements you want to make
Following with actions taken (CAPA)
Enhancing your skills with training
Providing you oversight through audit
Building your quality culture
*The second most common 483’s issued by FDA in 2023 relate to the quality system and continuous improvement via change control and CAPA.
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Be inspection ready
Are you confidant that you’re as ready as you can be for regulatory inspection or your customers audits, or do you have gaps? We can help you :
Measure and improve the maturity of your quality system.
Train you on the inspection and audit process and expectations.
Perform ‘mock’ inspections and audits.
Coach individuals and teams on improving performance.
Track gaps to closure and demonstrating proof.
Improve your readiness and peace of mind.
Being inspection ready means you’re consistently able. Assuring the public, subjects, and patients that you’re doing your best you can to improve healthy outcomes.
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Being inspection ready
Are you at an even earlier phase?
Start down the right path and stay on it
Why try to start out using the wrong tools to manage your compliant systems. I can provide you with a turn key QMS, repopulated with the core SOPs you need to get going and be compliant from day one. Right sizing your QA function for when you need support, and providing the training you need to demonstrate compliance. Hit the ground running!
