Optimized Acceptance Testing for Continuous Process Verification

$34,990.00

The Kymanox team of technical experts provides turnkey services for optimizing product/process sampling plans aligned with Continuous Process Verification (CPV) that is an expectation of the FDA per Industry Guidance Document, Process Validation: General Principles and Practices, Section IV.  Partnering with us can provide you with the following benefits:

  • Improved understanding of sources of process/product variation
  • Support for transitioning to variable based methods, where applicable, which often requires fewer samples than pass/fail test methods
  • Support for resource allocation and for decreasing opportunities from variations commonly associated with multiple technicians/analysis over a multi-shift operation
  • Increased knowledge and actionable information that can be used to drive process efficiencies
  • Formal summary report of product/process assessment that can be referenced as needed for submissions, complaint investigations, auditing, change control, and potential CapEx and OpEx requests

Overview of 3-Week Assessment

  • 2-day On-Site Working Sessions with Kymanox SME(s) to review product/process.
  • For one product or one process servicing multiple products under a single platform, Kymanox will:
    • Evaluate data generated through the entire supply chain including incoming testing of raw materials, in-process testing, and functional release testing
    • Conduct capability analyses for both variable and attribute data
    • Identify observed trends
    • Recommend an optimized sampling plan tailored to meet the product/process requirements and provide the most useful (actionable) information
    • Recommend sampling strategy for continuous process verification
  • Kymanox deliverables will include:
    • Slide Deck Summarizing Highlights from Data Analysis
    • Formal Report that includes:
      • Assessment of all data analyzed
      • Recommendations of Optimizing Sampling/Acceptance Testing

Base price: $34,990.00

Please contact our team directly at info@kymanox.com to discuss custom options to meet your company’s specific needs in regards to optimizing Sampling Plans for Continuous Process Verification.

SKU: SER-01 Category: