11 Compliance
Consulting
“Compliance isn’t just a job function
— it’s a cultural mindset.”
It should be embedded in every department, supported by effective tools and strong oversight, to drive organizational success.
At 11 Compliance Consulting, we bring deep subject matter expertise in quality systems management, with a focus on compliance with 21 CFR Part 11 and Annex 11. We specialize in providing practical implementation guidance—from procurement through deployment—for your next Electronic Document Management System (EDMS), Learning Management System (LMS), or Quality Management System (QMS).
Our Services: End-to-End or Specific Needs
“Keeping You in Compliance” is not just our mission—it’s our promise.
At 11 Compliance Consulting, we support clients through every phase of the electronic quality system lifecycle. Whether you need comprehensive, end-to-end support—from system selection through implementation, validation, and ongoing maintenance—or targeted assistance with a specific system, process, or initiative, our team delivers tailored, efficient solutions aligned with your compliance goals.
Expert Guidance for System Selection
When it’s time to select a system, you can count on 11 Compliance Consulting to guide you through every step of the process. We help you assess your needs, draft your Request For Proposal (RFP) and evaluate vendor options, to ensuring you make informed, strategic decisions for your eDMS, LMS, or QMS solution.
Whether you’re performing a software or Part 11 gap assessment, or revisiting your RFP to confirm your current system remains the best fit, our expert insights—rooted in years of experience and up-to-date regulatory knowledge—offer the strategic support you need to make confident, informed decisions.
For implementation, we work alongside your team to ensure smooth system deployment. Our experts analyze your workflows and processes to guide configuration and adopt a risk-based, least-burdensome approach to validation—letting you stay focused on your core mission with confidence in compliance.
After system release, we remain a dedicated partner. We provide team training, including “train-the-trainer” programs, create high-quality instructional materials (Training presentations, SOPs, Work instructions, etc.), and integrate content into your LMS. Our managed services cover ongoing maintenance, system evaluations, and rapid issue resolution to reduce downtime and ensure long-term success.
Explore our services to see how we can help keep your organization compliant, efficient, and audit-ready. “Your success is Our success”