Compliance Group Inc. (CG) brings a unique angle to the Quality/Compliance Technology space. Our story begins with roots as a subject matter expert (SME) in staffing on computer system validation (CSV) for all types of software. So what? There are a lot of CSV staffing companies, consulting companies, and ALM technology companies. However, none of them are like Compliance Group.

With our foundation in CSV, we have rapidly expanded the depth and breadth of our capability and talent in the areas of strategic Business Process Consulting, Technology, and Organizational Change Management (OCM). We are now on an exciting trajectory in executing our Mission for our customers, which is “To enable the fastest path to Quality Excellence.” From our vast CSV experience, we know many of the technology solutions used across the value chain…we understand their intended uses, their requirements, how to assess risk, how to assure/test, which solutions will match best given the customer’s culture, etc. With an agnostic approach to technology and OCM methodology, we can enable high quality across the value chain for our customers, driving high Design Quality, High Manufacturing Quality, High Supplier Quality High IT Quality, High Regulatory Quality, etc. Even our Vision is unique and aspirational. As most of us have a Life Science background, we have all experienced “friction” in Quality. Our Vision is to flip this: “To make Quality Frictionless.”

Compliance Group Inc. (CG) is a “customer intimacy” focused company. We are relentlessly curious in understanding our customers’ challenges, and we’re passionate about solving big problems that will make a difference for them, the industry, and the patients and healthcare providers we all serve. With our vast staffing network of specialized niche SMEs, our business process thought leaders, our technology expertise, and the recent addition of our OCM practice, we help create coherency in resourcing people, processes, and technology to drive adoption and value.

As a thought leader, we have been at the forefront of shaping the new FDA risk-based Computer Software Assurance (CSA) methodology and thought process. Our very own Industry leader, Jason Spiegler, SVP Strategy, Sales, and Customer Experience co-created the CSA initiative back in 2016 with the FDA, while he was with Siemens Digital Industries. As formed, what eventually became known as the FDA-Industry CSA (FICSA) team, a group of creative and innovative people who like to challenge the status quo and happen to know validation, CG was one of the founding team members. Ever since, Compliance Group has helped the FICSA team to evangelize and educate the Life Science industry on the application of critical thinking for CSA.

We have done hundreds of public webinars, conference presentations, and individual company presentations on CSA. Compliance Group developed a Digital CSA solution 6+ years ago, before most companies had even heard of CSA. In addition, our counterpart, Khaled Moussally, EVP Corporate Development and Operations participates on the ISPE GAMP Americas Steering Committee and has co-authored several Good Practice Guides (GPGs) including the "Data Integrity by Design” in 2020, “Enabling Innovation” in 2021, and GAMP 5 2nd Edition in 2022.