Compliance is not a job function, it’s a cultural attitude. Compliance permeates every department, and combined with effective tools and oversight, results in organizational success.
11 Compliance Consulting offers subject matter expertise on quality systems management, with a concentration on compliance to 21 CFR Part 11 and Annex 11 requirements. Our primary emphasis is providing implementation guidance from purchase to deployment 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 compliant solutions. Kate is closely involved with aspects of both business development and client engagement.
Kate brings more than 20 years of compliance experience within the pharmaceutical, biotech and medical device industries.
11 Compliance focuses on helping clients with all stages of electronic quality system implementation. We are committed to finding the best solution for each client’s specific needs in the most efficient way possible.
Project Management: We partner with your company to design the best strategy for implementation and deployment to yield the greatest success.
Configuration: We work with you to clearly identify your business needs to ensure full optimization of available applications and solutions. We partner with you to configure to your specific user requirements.
Validation: We design validation documentation according your company’s processes and procedures. We guide you through the process of accepting vendor provided documentation, closing validation gaps and verifying that all identified risks are appropriately mitigated.
Training development and delivery: We develop custom interactive learning programs to maximize your training budget, emphasizing end user adoption and sustainability.
Maintenance and Evaluation: We provide long-term strategies for post-release system management and continuous software compliance.
Find out how 11 Compliance can help you meet your goals. Contact us today.
We are hiring! Contact us today to find out more.
Tel: 617-314-6888 | Email: email@example.com