11 Compliance Consulting is a premier consulting firm specializing in quality systems management and compliance solutions. With a focus on compliance to 21 CFR Part 11 and Annex 11 requirements, we provide subject matter expertise to ensure your organization meets regulatory standards. Our core service offerings include implementation management for electronic document management systems (EDMS), learning management systems (LMS), and quality management systems (QMS).

From purchase to release, our team will guide you through the entire process, ensuring a seamless transition and successful implementation. Led by Kate Creegan, our owner and founder with over 20 years of compliance experience, we pride ourselves on delivering exceptional results. With a deep understanding of the pharmaceutical, biotech, and medical device industries, we offer tailored solutions to address your unique compliance needs.

At 11 Compliance Consulting, we are committed to partnering with organizations to achieve compliant solutions. Contact us today to learn how we can support your compliance journey