About Brayearst Validation Consulting
Meet Our Founder
Stephanie Brandford, Founder & CAGES® Framework Steward
After spending 20+ years working in FDA-regulated manufacturing, I founded Brayearst Validation Consulting to apply my experience in validation, training, and documentation review. As Steward of the CAGES® Framework, I help life sciences teams strengthen validation practices, improve documentation, and build audit-ready confidence by combining process knowledge, practical guidance, and real-world experience.
The Brayearst Evolution
Brayearst originated with the goal of helping smaller companies address FDA-regulated manufacturing challenges through external validation expertise. As the business progressed, Brayearst developed the trademarked CAGES® Framework to provide a structured approach for delivering targeted training and document spot check reviews. Today, our services focus on building internal capability for validation teams, providing practical training and review tools to strengthen FDA compliance readiness.
Our Framework: CAGES®
The CAGES® Framework delivers a structured way to approach process validation by organizing project elements into four clear phases:
Claims — Define the intended outcomes of the process.
Approach — Establish how the process will demonstrate consistently achieving those outcomes.
Gathering Evidence — Collect the necessary documentation to support validation.
Summary — Present findings to demonstrate process control and compliance readiness.
The framework simplifies complex validation work, allowing teams to strengthen both documentation quality and confidence during regulatory inspections.
Who We Serve
Brayearst supports life sciences manufacturers (including medical devices, pharmaceuticals, and biologics) through targeted validation training and document spot check reviews. We help teams responsible for process validation, cleaning validation, software validation, test method validation, and contamination control strengthen documentation and internal capability, preparing confidently for FDA audits and inspections.
Company Credentials
Brayearst Validation Consulting was founded in 2023 and is headquartered in Maryland.
Certified as an MBE, WBE, DBE by the Maryland Department of Transportation and the City of Baltimore
Certified EDWOSB by the U.S. Small Business Administration
DUNS®: 125667420
NAICS: 541614, 541690, 611430
Let’s Talk
We're always open to conversations about improving validation outcomes. You can follow Stephanie on LinkedIn at founder.brayearst.com or schedule a meeting directly at meet.brayearst.com.
Let’s build strong, sustainable validation practices together.
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 spam folder) for our follow-up email to schedule an introductory conversation.