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Aligning Quality Systems to Business Needs

Quality Systems Solutions for Pharmaceutical and Medical Device Companies

Shattered

You want to develop your Quality System but are unsure what to do next.

Maybe your current Quality Systems is not meeting your company needs.

 

Or, you need support with planning or executing your Quality System development and implementation.

Quality Systems are the backbone of a successful pharmaceutical or medical device company.

A quality system ensures that your manufactured products are safe and effective. However, the most effective quality system is the one that aligns with your business needs and meets regulatory requirements.

What’s worse than having no Quality System?

Having an overly complicated Quality System.

An overly complex system is difficult to follow and maintain, which leads to deviations, nonconformances, and, ultimately, an FDA inspection with poor results. The process of creating and remediating quality systems can be time-consuming and overwhelming. Having the right partner to navigate the process can ease your burden.

With a well-functioning quality system, your company can:

  • Compliance with Standards and Regulations

  • Improved Product or Service Quality

  • Reduced Costs

  • Enhance Customer Satisfaction

  • Continuous Improvement and Innovation

Quality Systems Services, LLC provides the guidance and knowledge to create a tailored quality system for your company. We get to know your business to create the best Quality System for your needs.

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.

We Can Save You Time and Create a Solution!

Building a Quality System for the future in this rapidly evolving environment means making insightful decisions on design and implementation. Let Quality Systems Services, LLC guide you.

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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