11 Compliance Consulting

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.

Our Services

11 Compliance Consulting 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.

News

11 COMPLIANCE CHECKLIST

INTRODUCTION 21 CFR Part 11 is an FDA guidance that sets out how organizations operating in the United States can use electronic records and digital signatures in their quality management systems to replace paper- based documents and ‘wet signatures’. Any organization that uses quality management and needs to conform to FDA regulations, such as pharmaceutical […]
Vital Signs of the Medical Device Industry

2021 Medical Device Trends Let’s just say what we’re all thinking: 2020 was rough. It threw pretty much every element of our lives into disarray, and we suddenly had to become experts at navigating a new way of working, schooling and socializing. It was disruptive, and it was challenging, but it was also transformative. While […]
FDA 21 CFR Part 11 and the importance of regulatory compliance in GMP and GLP labs

The regulations for food and drugs in the United States, described in Title 21 of the Code of Federal Regulations (CFR), are critical in ensuring safe and ethical drug administration. Whether you are an academic institution, a government agency, or a pharmaceutical company, you have to adhere to these rules at each step of the […]