We Help You Build Audit-Ready Validation Confidence
Training • Spot Checks •
Powered by CAGES®
Welcome to Brayearst
Brayearst Validation Consulting strengthens life sciences validation practices through targeted training and document spot check reviews, delivered using the trademarked CAGES® Framework. We help teams build audit-ready confidence and internal capability to meet FDA compliance expectations.
Let’s explore how Brayearst can support your team’s validation needs; through training, documentation reviews, or strategy assistance. Please complete the form to start the conversation.
Once you submit the form, please check your inbox (including your junk or spam folder) for our follow-up email to schedule an introductory conversation.
What We Offer
At Brayearst, we apply Six Sigma methodology to a full spectrum of validation needs. Our services are ideal for life science organizations in pharmaceuticals, biologics, and medical devices seeking actionable insight and lasting results.
Our Core Services Include:
Training & Capability Building
Brayearst provides orientation training using the trademarked CAGES® Framework, designed to help professionals build a practical understanding of process validation, documentation structure, and FDA regulatory expectations.
Validation Spot Check
We perform expert document reviews of completed validation packages to help companies identify gaps or weaknesses before they create regulatory exposure. Spot check reviews apply our CAGES® Framework to assess claims, documentation completeness, and consistency across protocols.
Why Brayearst?
With over three decades of industry experience, our founder has trained, led, and executed across the full spectrum of validation activities in both chemical and medical device manufacturing. Our difference is our depth:
30+ years in chemical and life sciences manufacturing
Chemical Engineering degree from Carnegie Mellon University
Extensive audit experience with FDA, pharma clients, and internal stakeholders
Certified Six Sigma Black Belt
Team leadership across multi-site operations
Business unit-level training and validation program management
Process Overview
When you partner with Brayearst, you’re gaining more than a service provider; you’re engaging a process that delivers confidence and clarity:
Initial Inquiry
Share your needs through our intake form or a brief discovery call.
Tailored Proposal
We develop a custom scope; whether for training sessions, document reviews, or strategy assistance.
Execution with Oversight
You receive timely, expert-driven services aligned with FDA expectations and internal goals.
Ongoing Collaboration
We check in, adjust as needed, and stay available as a partner in your continued success.
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"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)
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“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)
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"Stephanie Brandford's engaging Six Sigma presentation added tremendous value. Her expertise at Brayearst Consulting is highly commendable."
Karen F. Underwood, MS, RAPS Member
Secure Your Manufacturing Future
Brayearst Validation Consulting addresses common challenges faced by FDA-regulated manufacturers: compliance uncertainty, documentation gaps, audit risks, and delayed product launches. Let’s work together to build stronger processes, greater confidence, and lasting success.