Regulatory compliance
Industry challenges
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.
Key questions:
- How to achieve cost reductions in the current compliance programs?
- How could Life Science companies build vendor programs to ensure regulatory compliance in all sourced activities?
- Which risk intelligent principles could be applied in managing compliance programs and projects?
- Which techniques can be adopted to ensure projects are delivered in time, on budget and compliant with company standards and international regulations and standards?
- What are the requirements to build a compliance program (including roles and responsibilities, methodology, templates,...)?
Deloitte offering - some approaches & credentials
Deloitte supported different Life Sciences companies in:
- Quality assurance for projects
- Control harmonization and process redesign
- Risk intelligence in life science compliance programs
- Vendor compliance management and audit
- Computer validation
- Internal compliance audit and remediation
- Compliance program set-up
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