11 Compliance

Massachusetts, USA



11 Compliance Consulting specializes in quality systems management, focusing particularly on compliance with 21 CFR Part 11 and Annex 11 requirements. Based in Swansea, MA, the firm excels in providing implementation guidance for Electronic Document Management Systems (EDMS), Learning Management Systems (LMS), and Quality Management Systems (QMS). They are committed to enhancing organizational success through comprehensive compliance strategies that permeate every department, supported by effective tools and oversight.

Services offered include:

  • Quality Systems Management
  • EDMS, LMS, and QMS implementation
  • Training Development and Delivery
  • Electronic Quality Management System (EQMS) configuration
  • Project management for internal and external clients

Regions served: 

  • Primarily the United States, focusing on organizations requiring robust compliance systems and quality management.