Forged by the fire of FDA...

The story of Compliance Insight, like most stories, starts with an epic, life-changing event.

In the 1980s, both founding executives were employed by FDA-regulated companies. By 1990, these were bad times for pharmaceutical drug makers and the FDA. Several officials from the agency pleaded guilty to receiving bribes, and various companies admitted to providing false data.

In this context, the compliance attributes of both executives were confirmed as central to FDA-regulated industry success. Although not knowing each other at the time, Cynthia Ipach, the President and CEO, and Troy Fugate, the Vice President, approached GxP in compliance with these core values:

• Do the right thing

• Comprehensive and systemic actions for compliance

• Flexible and options oriented but keeping the compliance goal on target

• Think things through and don’t act without facts but make it happen by not suffering from analysis paralysis

• Positive attitude in everything

• Being empathetic with all stakeholders – to seek first to understand and then to be understood

In 1995, these two executives met for the first time while working at Pfizer. They developed a formidable team dynamic that spawned the idea of finding like-minded specialists to provide a systemic yet practical compliance approach to the FDA-regulated industry. From that point on, there was no stopping the two of them...

Cindy started in 2000 to get things rolling, and Troy joined in 2001. By Dec 2016, approximately 60 colleagues were working for Compliance Insight in the US and Canada - making them an international corporation. Compliance Insight has engaged large international firms with virtual companies, conducting various compliance projects in North America, Europe, and Asia.

In 2018, it was revealed that Compliance Insight had been named the Company of The Year by a prestigious industry magazine. This recognition comes after they were previously ranked among one of the Top 10 Pharmaceutical Compliance Solution Providers in 2016, 2019 and 2021 respectively - all while maintaining an impeccable quality assurance service record!

How have they maintained this growth and success? It all centers around their team...

What makes their team different: The skill sets of an Extraordinary Compliance Insight Colleague?

Compliance Insight will specifically hire, fire, review, and promote under a set of core values listed above as developed by the firm's two founders. Like the compass pictured here, one can wander throughout their career without vision and direction or focus on the wrong things. With the right core values, one can make a difference in the world!

Their goal is to set standards (called "Codes") for everyone working for Compliance Insight, not just to be a good service provider but one that is considered extraordinary! To be frank, good is their enemy!

These codes encompass the entire dynamic of working for Compliance Insight and embody their core values. The Code of Commitment is to their clients - what Compliance Insight will deliver once engaged. The Code of Conduct and the Code of Ethics are for their colleagues - everyone abides by these fundamentals - from the office staff to subject matter experts.

These all sound great, but how do you implement them? What is your proven process?

That's a great question! Cindy and Troy were thrilled to draw out the simple proven process. It centers around three key steps: Align - Apply - Adapt.

With hands waving wildly, Troy excitedly explained that the fundamentals could fit into any situation. He states that three things compose all companies - A Work System, A Work Place, and A Work Force.

For the "WorkForce," their company utilizes TACM, which stands for Train, Audit, Coach, and Mentor. The other two, "Work Place" and "Work System," use PDSA - representing Plan - Do - Study - Act.

Each process requires aligning with client objectives, applying the tools to complete the task, and adapting to the situation based on the data.

Seems simple and, as the Leadership Team at Compliance Insight exclaimed, has been successfully utilized for many projects, large and small, ranging from Consent Decrees to Regulatory Filings.

So what is in the future for Compliance Insight?

The entire Leadership Team at Compliance Insight has a ten-year vision that they are energetically working toward - with a very detailed plan of action.

Like their proven process, the vision is simple - Be the premier GxP compliance service provider! They have no direct plans to be the biggest, but they certainly will be the best!

Compliance Insight, Inc. is a compliance service provider serving pharmaceutical, medical device, biologics, and OTC companies worldwide. Their company headquarters is near Cincinnati, Ohio, but their colleagues are situated around the entire US and Canada, with strategic relationships to perform services in Europe, Asia, and South America. IE