What do compliance and your electric company have in common? Both are critically important, but many people don’t notice them until something goes wrong…
Compliance is often regarded as a back office activity, but it is truly the backbone of the business in heavily regulated industries. For companies in life sciences, from pharma and medical devices to digital health and lab management, meeting compliance standards is a critical business need and often quite literally the lifeline of the company.
And compliance is complex. Compliance needs differ based on industry and even company to company based on a myriad of factors: which agencies regulate the company? In which geographies? What policies does the company have in place? How is compliance divided across departments in the company? And not only are compliance needs not one-size-fits-all, they are also ever-changing. as new regulations or new products come online.
While large-cap companies have big compliance teams with big budgets, small and medium companies in life sciences shoulder massive responsibility but have two less-than-perfect options.
They can hire a professional services team to tailor and implement a compliance solution that meets the company’s specific needs. But once a professional services team is involved, costs are often prohibitive, implementation times are long, and the project never really ends given changing regulatory needs.
Conversely, some companies use an out-of-the-box digital solution, which is far less expensive and quick to implement. However, these solutions are rigid, one-size-fits-all programs that follow best practices but don’t address the specifics of each company’s requirements. Here, companies need to mould their compliance needs to fit the solution, rather than the solution adapting to the company’s needs.
The result? Many small and medium companies stay with paper-based systems long after the compliance teams want and need a digital solution. In life sciences this is particularly ironic, since companies doing cutting-edge science and delivering state-of-the-art products and services don’t have the resources to move to a digital solution.
Compliance teams in small and medium companies need and deserve the same high-quality compliance systems as the big players. And they can’t afford to wait until their company grows, both because regulators and customers aren’t waiting and, more importantly, because compliance is key to a company’s DNA. Technology is now making it possible, for the first time, to level the compliance playing field by offering small and medium companies the same quality compliance systems as the big players, without having to choose between affordability and quality.