Gap Assessment Audit

At Qualitas, we understand that a robust quality system is the backbone of every successful CPG brand and manufacturing operation. Our Internal Gap Assessments are designed to proactively strengthen your foundation, identifying crucial improvement opportunities within your existing quality management system. We don't just find the gaps; we provide a clear, actionable roadmap for continuous enhancement and a solid base for your long-term success with Fractional Quality Management.

In the dynamic world of dietary supplements, food, cosmetics, and beverages, staying ahead of regulatory changes and industry best practices is paramount. Our expert team delves deep into your current operations, benchmarking them against applicable regulatory schemes and industry standards to ensure you're not just compliant, but optimized for growth and consumer trust.

Our comprehensive assessment reviews your quality system from start to finish. We conduct thorough evaluations against various regulatory frameworks and industry benchmarks, including:

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  FDA 21 CFR Part 111 (Dietary Supplements)
  

  FDA 21 CFR Part 117 (Food)
  

  ISO 22716 or NSF/ANSI 455-3 (Cosmetics GMPs)
  

  GFSI-benchmarked schemes
  

  Hybrid+ schemes tailored to your unique needs

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  Initial Consultation: We begin by understanding your specific needs, current system, and regulatory landscape.
  

  Documentation Review: Our experts meticulously review your existing Quality Management System (QMS) documentation, including SOPs, records, and policies.
  

  On-site Evaluation (or Remote, if applicable): We conduct a thorough assessment of your facilities and processes to identify any deviations or areas for improvement against chosen standards.
  

  Comprehensive Report Delivery: Within 48 hours of completing the assessment, you will receive a detailed report outlining identified gaps, their potential impact, and clear recommendations for corrective actions.
  

  Prioritized Action Plan (Optional): We can develop an optional 90-day prioritized action plan, providing you with a step-by-step guide to implement improvements effectively.
  

  Debrief & Strategic Planning: We will debrief our findings with your team, discussing the roadmap for improvement and how to build a stronger foundation for your quality operations.

Our Internal Gap Assessments are more than just a review; they are the critical first step towards optimizing your quality operations. The insights gained provide a strong foundation for integrating our Fractional Quality Management services, ensuring long-term success and sustained compliance without the burden of rigid, outdated systems.