Strategic Partner

11 Compliance Consulting

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.

Compliance Services: FDA 820
• Support Clients in Rolling Out Electronic Quality Systems to Comply with FDA 820 
• Systems Validation
• SOP Development, End-User Training and Acceptance