Addressing Compliance Technology Space Challenges: A Client-Centric Approach by Compliance Group
What are major challenges to quality improvement in Compliance? This is a question we at Compliance Group asked ourselves, which drove the initial framing of our strategy, restructuring of our organization, and prioritization of investments. We determined six major frictions that impede Quality Excellence for our customers, which increase exponentially as you move across the value chain. They are:
- Constrained Resources
- Cumbersome/Inconsistent Procedures
- Fragmented Business Processes and IT Systems
- An Overly-Conservative Regulatory Interpretation
- Cultural Resistance
- Organizational Complexity
We have met with hundreds of companies over the past year, and there was unanimous head-nodding when we introduced our “Friction” slide. Depending on the customer, at least two of these challenges always seemed to resonate.
Most companies have great talent, but they experience the friction of Constrained Resources, defined as lacking the right skilled workforce, at the right time, in the right location for the right duration.
Most companies have compliant procedures, but they introduce friction by making them very cumbersome to execute. As the company grows, its procedures become inconsistent, which increases inefficiencies and compliance risk.
Almost every company lists “Fragmented Business Processes and IT systems” as one of their top two Frictions. Think of all the different workflows a company has across their value chains. Now think about all the disparate systems that are used across a workflow – IT Systems, homegrown excel databases, email, and other manual systems. The fragmentation creates significant friction for speed, efficiency, quality, compliance, and employee experience.
An Overly Conservative Regulatory Interpretation is a friction we see frequently. In most cases, the Lifesciences Manufacturer is doing things in a very cumbersome way because they think that’s what the Regulator wants. We have clarified many misperceptions for our customers, saving them significant time, money, and frustration.
Cultural Resistance is the biggest friction causing business processes and digital transformation to fail. It is an indication that the organization hasn’t invested in developing internal cross-functional change leaders with the right OCM (Organizational Change Management) skillsets and methodology for their culture.
And finally, Organizational Complexity can drive great friction, especially when some of the other frictions are at play. I know most Plant Managers read hearing, “I’m here from Corporate and I‘m here to help.”
It seems like many organizations play “whack a mole” with these frictions. They staff people to close an immediate hole, but then another hole opens due to an “overly-engineered for compliance” business process. They plug inefficiencies by streamlining a part of a business process, but then don’t consider how to digitally thread the process. Their focus is then drawn to changing or upgrading technology, without considering how new technology impacts the business process. More holes are created as a “tool” is selected without considering its cultural, holistic or logistical fit in the overall workflow.
Many organizations fail to realize that a holistic approach is required, including a shift in mindset. As a result, the company limps along in slow incremental improvements, without ever really eliminating or even minimizing these frictions, and don’t achieve the value they expect. Compliance Group recognizes that a holistic approach is mandatory. Given our deep regulatory compliance knowledge, industry thought leadership, collaboration with Regulators, and our technology and OCM expertise through the lens of validation, we bring a unique and significantly-differentiated perspective to assessing and minimizing friction for our customers.