Compliance Group
Enabling the Fastest Path to Quality Excellence

Compliance Group’s (CG) story began as a subject matter expert in staffing computer system validation (CSV) for all types of software. Over the years, it has rapidly expanded the depth and breadth of capability and talent in the areas of strategic business process consulting, technology, and organizational change management (OCM). Today, the company is bringing a unique perspective to the quality/compliance space.

“We are now on an exciting trajectory as we execute our mission for our customers: to pave the quickest route to achieving excellence in quality,” says Jason Spiegler, the SVP of Strategy and Customer Experience at Compliance Group (CG).

From its vast CSV experience, CG understands the intended uses and requirements of the technology solutions used across the value chain. It comprehends how to assess risk, how to assure/test, and which solutions will match best given a customer’s culture.

With an agnostic approach to technology and OCM methodology, CG can enable high design, manufacturing, supplier, IT, regulatory, and quality across the value chain for customers.

The approach begins with CG’s assessment of a customer’s “as-is” vs. “to-be” skillsets, business process workflows, digital technology roadmaps, and organizational culture. From there, CG can co-create and execute a plan based on the culture to remove/ minimize friction while driving higher quality where required in their value chain. What enables the company to take this process seamlessly is its business process thought leaders, technology expertise, and recent addition of its OCM practice. As a result, CG is able to create coherency in resourcing people, processes, and technology to drive adoption and value.

CG has also been at the forefront of shaping the new FDA risk-based Computer Software Assurance (CSA) methodology and thought process. Spiegler co-created the CSA initiative back in 2016 with the FDA while he was with Siemens Digital Industries.

He 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, who are also computer system validation experts.

The company has helped the FICSA team to evangelize and educate the life sciences industry on the application of critical thinking for Computer Software Assurance (CSA). The company has done hundreds of public webinars, conference presentations, and individual company presentations on CSA. This has assisted it in solving many of its clients’ predicaments.

We are now on an exciting trajectory as we execute our mission for our customers: to enable the fastest path to Quality Excellence

As an example, Flex, a $30 billion+ contract manufacturer with a $6B health division, collaborated with CG to implement a robust risk-based Computer Software Assurance (CSA) business process. The goal was to test smarter while significantly reducing the time and documentation required. After demonstrating significant value with a manual CSA process, Flex invested and adopted a Digital CSA process using the Siemens Polarion technology implemented by CG.

With a digital data-centric CSA solution, Flex was able to significantly increase the velocity of change while error-proofing their validation activity and visualizing end-to-end digital threads of their impact analyses.

Given its deep regulatory compliance knowledge, industry thought leadership, collaboration with the regulators, and OCM expertise through the lens of validation, it’s a no-brainer that CG brings a unique and significantly differentiated perspective to assessing and minimizing friction for customers.

As Spiegler rightly mentions, “What’s important is to solve the customer’s problem, regardless of partner, tool, technology, or methodology.”