RESULTS: We engaged with life science technology leaders to collaboratively create and implement a playbook, filled with best practices, easy-to-implement roadmaps, and tools. This strategic approach saves time, minimizes confusion, and trims budgets. Audit teams report fewer audit issues and a more streamlined process. Due diligence teams are empowered with well-thought-out standard operating procedures and transparent disclosures foster confidence and clarity.

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CHALLENGE: The life science industry was struggling with mixed messages from the FDA on how to set up information technology infrastructures to assure compliance with privacy and security regulations.  The FDA had no roadmap or established rules and guidance to provide companies. The question on the table was, “if out of 100 companies, there are 99 different ways to do this, what is the right way?”

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ACTIONS: Listening to this challenge, we recruited leaders from across small and medium-sized life sciences enterprises: medical doctors, attorneys, regulatory affairs experts, chief information officers, information technology developers, project management professionals, data center owners, due diligence teams, and FDA auditors to define the problem in detail and scope. We established the Life Sciences Information Technology Global Institute. Within the Institute, we created the first ever Good Informatics Practices Guidance document and published six chapters of tools and resources:
 

1. IT Ecosystems & Governance

2. IT Risk Management

3. Verification & Validation

4. Training

5. Security

6. Data Management