Expanding horizons of Ethics, risk and compliance (ERC) in Pharma

 Ethics, risk and compliance (ERC) has become a priority for organizations around the world, more so for pharmaceutical companies. The pharma sector, by nature, is volatile and given this, individual companies have put in considerable efforts to develop robust ERC frameworks and guidelines to be abided to. Initially considered as different departments, ERC has evolved to become a single function and has been a strategic enabling partner for organizations.

The need for an upgrade

The pharmaceutical industry is rapidly changing and this ever shifting landscape calls for an upgrade in the ERC function as well.  The truth is that without modernizing ERC operations, it will eventually become difficult for pharma companies to leverage ERC’s expertise. We are witnessing the way regulatory requirements are becoming more stringent and the growth in the regulators’ precision and speed to identify risks. As these factors increasingly come into play, the ERC function will have to become more agile and sophisticated and thus, the adoption of digital technologies seems the most relevant stage of progression.

How can digital help?

The value that digital technologies can add is innumerable. They make it possible to bring in more efficiency in routine tasks, to maintain and analyze the huge amounts of available data and transform ERC operations in a way that can help us predict the risks ahead and also provide solutions to navigate through them.

Leveraging data and digital in ERC operations, help us pin point unidentified indicators and behavior patterns that accompany issues that are non – compliant. These indicators can be detected from amongst hundreds of variables that are otherwise humanly impossible to identify. An area where machine learning and advanced analytics can be of significance is predictive maintenance. Pharma, as an industry, is reliant on varied high-performance components and shifting to a digital driven approach, in this case, can result in cutting down costs considerably.

A very important aspect where digital innovations can be useful is third party risk assessment. A background check for third parties usually involves analyzing information that, more often than not, does not tie back to a source point. Using data and digital technologies can help analyze and present information about them from different systems and public sources which might bring to the fore their linkages to high-risk parties/individuals.

The way ahead

The use of data and digital in the ERC function is still at a nascent stage for pharma companies. There is a lot of potential in these tools and including these in the overall ERC strategy will help add value to the overall organization in a meaningful and impactful way than it has ever done.

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