How We Work:
Project-Based
Fractional Support
QMS Packages
Kate Ashley Solutions provides fractional quality assurance, quality systems, and compliance support for healthcare, biotechnology, pharmaceutical, med tech, and medical device organizations. We help startups and growing companies build the quality infrastructure needed to move confidently through each stage of growth while maintaining practical, scalable systems.
Our services are designed to provide flexible support based on organizational needs—from targeted projects to embedded fractional quality leadership. Whether building a quality foundation, preparing for audit readiness, strengthening operations, or expanding existing systems, we deliver solutions that align quality with business goals.
Services
Quality Management Systems (QMS)
QMS Development & Implementation
QMS Gap Assessments
QMS Remediation & Improvement
Quality System Documentation
SOP and Documentation
SOP Development & Customization
SOP Package Libraries
Fractional SOP Support
Complete QMS Documentation Packages
Document Control Support
Audits and Compliance
Internal Audits
Audit Readiness Assessments
FDA & ISO Compliance Support
Supplier Audits & Supplier Quality
Inspection Preparation Support
Fractional Quality Readiness Program
Scalable Quality System SOPs
Fractional Quality Assurance Support
Interim Leadership
Quality Operations and CAPA
CAPA Management Support
Deviation & Nonconformance Management
Root Cause Analysis
Risk Management Support
Change Control Support
Training Support
Quality 101
Good Documentation Practices
Initiate Your Consultation
Submit the form outlining your objectives, and a consultant will respond promptly to discuss how our expertise can advance your goals.