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Elementis Global
The Process And Culture Requirements For Exceptional Regulatory Technology
Greg Bellotti
Historically, regulatory projects were passed to IT departments to check the box meeting a compliance or audit standard. For some projects, staff were trained to adopt new process steps with little or no follow-up. Others created audit reports or alerts if activity surpassed limits. Since regulatory projects do not produce revenue, actually they created cost and add time, business buy-in was difficult to sell. For small-medium businesses, especially multi-national businesses, overspending on regulatory projects (technology, implementation, and continuous operation) could significantly impact operating profit. In six sigma terms, these projects were waste.
But what happens if you are non-compliant? What are the implications? Should we weight the cost of non-compliance as a measured risk?
Holistically, Global IT had many tactical efforts to complete; TOMS, DPIA’s, DPO, etc. It seemed every vendor was selling a service and toolkit. Timelines were tight, and those engaged were frantic with details and checklists. Making matters a bit more challenging was the ambiguity of directives and how to best apply the “reasonable” factor into our plan.
Reviewing risk, project plans, budgets, and new regulations in the wings, it became apparent we needed a strategic shift to properly manage GDPR and all compliance projects. We concluded we must treat them as revenue-producing projects, projects critical to our sustainability.
Organizationally we learned that technology itself would not solve HR operation or customer management challenges;
our success in the aforementioned was a result of intradepartmental understanding, process discovery, and strategic goals mapped to a technology solution. That would be the methodology we would apply to regulatory compliance.
No longer small, regional solutions—our regulatory mission adopts best practice methodology we employ for safety, manufacturing, sales, and data management. Management committed cultural adoption of platforms, processes, and people to operate within regulatory compliance rather than report on it as a by-product of various tools
Regulatory excellence at all levels:
• Data protection
• Legal protections and requirements
• Financial regulations
• Product registration and sales regulations
• FDA/EMA
No longer a burden of effort but a strategic investment to differentiate Elementis as a global leader and steward of exceptional operations enhanced with strategic technology.
Being extraordinary in your regulatory space requires understanding how you must operate at a process level, adopt process operations culturally and crystalize them together with strong technology platforms that meet your current and future needs.
