Brayearst Validation Consulting — Safeguard your Business with Expert Validation for FDA Compliance and Process Optimization using Six Sigma.

Inquiry Form

Are you still thinking about how to bring your processes into compliance and achieve operation excellence? Thank you for your consideration in meeting your validation consulting needs with Brayearst.

Please provide your contact information and any details you’d like to share for us to move forward with your project.

Professional hands typing on a laptop keyboard, planning for FDA compliance and Six Sigma validation projects with Brayearst Validation Consulting.

Are you ready to invest in your business to experience uninterrupted manufacturing and revenue generation while satisfying regulatory requirements?

Once you've sent this form, remember to check your email, including any junk or spam folders, for a follow-up message to prepare for our initial consultation. Looking forward to hearing from you!

Female professional analyzing data on a computer with digital manufacturing images, highlighting Brayearst's tailored validation services for life sciences.

At Brayearst Validation Consulting, we offer a comprehensive suite of validation services tailored to meet the unique needs of life sciences companies. Our approach leverages Six Sigma methodology to ensure your manufacturing processes are not only compliant but also optimized for long-term success.

  • Installation Qualification (IQ)

  • Operation and Performance Qualification (OQ/PQ)

  • Process Performance Qualification (PPQ)

  • Cleaning Validation (CV)

  • Software Validation or Computer System Validation

  • Test Method Validation or Analytical Method Validation

  • Validation Master Plan

  • Validation Training

  • Six Sigma Training

Grid of cartoon headshots representing the diverse expertise of Brayearst Validation Consulting's team, reflecting decades of industry experience.

At Brayearst Validation Consulting, our edge lies in the depth and breadth of our founder's experience over three decades across the chemical and medical device industries. Here's what sets us apart.

  • Industry longevity - over 30 years experience in chemical and medical device manufacturing industries

  • Educational background - Bachelor’s degree in chemical engineering from Carnegie Mellon University

  • Regulatory insight - defended validation documentation in audits by FDA, pharmaceutical customers, and corporate

  • Six Sigma Black Belt certification - completed projects; trained and mentored other Black and Green Belts

  • Leadership and team management - led a team of validation engineers supporting three facilities

  • Training expertise - trained and developed training content on validation topics

Process Overview

Here’s what you can expect when working with Brayearst Validation Consulting.

(1) First, completing the inquiry form starts the information sharing necessary to build a proposal.

(2) Next, accepting the proposal starts project activities to meet your needs.

(3) Finally, you can go to market with confidence that your validation documents will hold up to scrutiny.

  • "In a very short time, Stephanie understood the functionality well enough to write detailed, challenging test cases, and provide effective training and troubleshooting support."

    Karol P.; Validation Manager, Becton Dickinson (BD)

  • “Stephanie did an amazing job at providing virtual training and sharing her changes with the Network so that others don’t have to start at the beginning!”

    Kelly L.; Validation Program Manager, Becton Dickinson (BD)

  • "Stephanie Brandford's engaging Six Sigma presentation added tremendous value. Her expertise at Brayearst Consulting is highly commendable."

    Karen F. Underwood, MS, RAPS Member

Get in Touch
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Secure Your Manufacturing Future

FDA-regulated manufacturers often struggle to keep up with compliance requirements, risking severe operational disruptions. Product quality issues can tarnish their reputation and market standing. Many companies lack the in-house expertise needed for comprehensive process understanding, leaving management concerned about validation documentation that might not withstand audit scrutiny. Additionally, scheduling delays in market entry can lead to significant revenue losses. Partner with Brayearst Validation Consulting to address these challenges and secure your business's future.