11 Compliance Consulting offers subject matter expertise on quality systems management focusing on compliance to 21 CFR Part 11 and Annex 11 requirements. Our primary emphasis is providing implementation management from purchase to release of your next EDMS, LMS, or QMS.
Owner and Founder, 11 Compliance Consulting Corp.
Kate Creegan is the owner and founder of 11 Compliance Consulting Corp., a firm dedicated to partnering with organizations in pursuit of compliance solutions. Kate’s work focuses on helping clients with all stages of implementation, documentation and maintenance of electronic quality systems, ensuring adherence to the most up-to-date regulations.
She has 16 years of compliance experience within the pharmaceutical and biotech industries.
Project Management: We direct the implementation of your next EDMS, LMS, or QMS.
Configuration: We work with you to identify your business needs so that we can tailor our solutions to your workflow.
Validation: We design validation documentation, execute protocols, and develop and implement remediation plans.
End-user Training: We provide effective training programs specific to your organization.
Maintenance and Evaluation: We help you deploy long-term strategies for post-release system management.
Find out how 11 Compliance can help you meet your goals. Contact us today.
Tel: 617-314-6888 | Email: email@example.com