Life Sciences organizations have seen a rapid increase in the introduction of new regulations and industry standards. Further, the industry faces increased risks on data integrity, privacy and security. The implementation of the regulatory requirements has often led to multiple and discrete compliance programs focusing on FDA, EMEA, but also SOX, privacy and many other regulations and standards. This led to high maintenance costs of regulatory programs and duplication of work. Companies are therefore investigating opportunities to achieve cost reduction through process improvement & control rationalization.
Another regulatory compliance challenge is the outsourcing of more and more activities to specialised companies e.g. Clinical Research Organisations, external labs, service organisations or partnership companies. This means that Life Sciences organisations become heavily dependent on the vendors’ regulatory compliance as the vendor’s non compliance could compromise the activities of the company.
Companies should adopt risk intelligent principles to focus the compliance effort more on the ‘real’ risks. Through process optimization, standardization and a risk based validation process, companies can achieve compliance at a much lower cost. Although regulators allow Life Science companies to apply a risk intelligent approach to compliance, a lot of companies struggle to find a strategy to get it working.
Deloitte supported different Life Sciences companies in: