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Aligning Quality Systems to Business Needs

Don't Let Ineffective Quality Systems Jeopardize Your Pharmaceutical or Medical Device Company.

Looking to develop your Quality System but not sure where to turn? Are your current quality systems failing to provide the assurance of safety and effectiveness your company needs? Need help planning or executing your Quality System development and implementation? Let Quality Systems Services, LLC guide you. Building a Quality System for the future in today’s rapidly evolving environment means making insightful decisions on design and implementation.

Who We Are

Quality Systems Services, LLC is a small consulting firm that works with pharmaceutical and medical device companies to navigate the complexities of compliance. With 25+ years of experience as an industry leader, owner and founder Kimberly Wallbank navigates these complexities of FDA compliance while maintaining the most efficient processes for their unique business needs.

Kimberly Wallbank has diverse experience and expertise in assisting pharmaceutical and medical device companies achieve compliance with FDA (21CFR210/211 and 21CFR820), ISO 9001, ISO13485 and other recognized standards and regulatory requirements. Whether it is a proactive implementation or a 483/warning letter/consent decree remediation, Quality Systems Services has worked with clients in achieving their compliance goals while reducing non-value-added activities.

Specializing in:

- Complaint Handling

- Deviations/Investigations

- Corrective Action/Preventive Action (CAPA)

- Risk Management

- Supplier Management

- Training

- Document Life Cycle

- Records Management

- Auditing

- Environmental Monitoring

- Manufacturing and Laboratory Systems

Why Should You Care About Quality Systems?

 

 

 

 

 

 

 

 

 

 

 

 

 

Quality Systems are the backbone of a successful pharmaceutical or medical device company. They provide assurance that the products manufactured are safe and effective. However, the most effective quality system is the one that aligns with your business needs and meets regulatory requirements. Quality Systems Services, LLC provides the guidance and knowledge to create a tailored quality system for your company.

 

Each part of your Quality System needs to work in concert with each other. Your training program needs to link with your documentation system to ensure that as new and updated Standards Operating Procedures (SOPs) are approved, and your staff that performs the activities in the SOPs are trained prior to use. Your Complaint Handling process needs to link to your CAPA program to ensure that corrections to your product or process are completed and effective to address and eliminate the determined root cause.

 

What is worse than having no Quality System? Having a Quality System is overly complicated! Why? Because an overly complicated Quality System is difficult to follow and maintain, which leads to deviations, nonconformances and ultimately, an FDA inspection with poor results. Quality Systems Services, LLC gets to know your business to create the best Quality System for your needs.

 

 

Let our Quality Systems Consultant Save You Time and Create a Solution!

 

The process for creating and remediating Quality Systems can be time consuming and overwhelming. Having the right partner to navigate the process with you can ease your burden. Let us at Quality Systems Services, LLC help you achieve this goal!

 

Contact us by filling out the form here or call 845-596-9666.

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Testimonials

Director of Operations, Nuclear Pharmaceutical Division of a Large Pharmaceutical Company

“Kimberly’s expertise and knowledge base were apparent from day one, but that is only what qualifies her for consultancy. The reason Kimberly was so effective was because she helped us understand and get to the root cause of our issues. How our processes set up our operators for failure, or how our training program was just checking a box and not providing an output of prepared employees – just a few examples of Kimberly’s findings that she helped resolve. I very much endorse Kimberly and believe she is not your cookie cutter consultant with zero vested interest.”

Associate Director, Head of Production Nuclear Pharmaceutical Division of a Large Pharmaceutical Company

“I had the pleasure of working with Kimberly to help us improve our quality systems program at our new manufacturing site in the U.S. Kimberly has shown to be an expert in investigation management, root cause and failure analysis, and implementation of effective CAPAs. She had the knowledge and expertise to promote a positive quality culture and instill continuous quality improvement for our company.”

Principal Engineer, Large Biopharmaceutical Company

“Kimberly is the ‘consummate professional’. She is extremely talented in conducting highly effective accurate GMP investigations. She has a strong knowledge of current good manufacturing practices (cGMP) and regulatory guidelines and is well versed in all QA functions necessary for our industry. She possesses outstanding technical writing, project managing, and analytical skills, utilizing these skills in composing clear, concise investigation reports written in a manner than readers less knowledgeable in the subject can easily understand. Her technical (scientific, engineering, single use materials, validation) knowledge is excellent as well. This understanding allowed for the technical investigation processes (e.g. data mining/analysis supporting hypothesis for RCA, product impact assessments) to be interpolated and entered to the investigations. Kimberly would also strive for corrections and process improvements and would ensure that these CAPA actions were implemented to allow for improved manufacturing.”

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