How to keep your life sciences facilities GxP compliant
How to avoid costly delays, FDA citations, safety and quality breaches, and more through integrated facilities management
It’s never been more important to ensure the medical products you’re bringing to market are safe and effective for consumers. Emerging therapies such as COVID-19 vaccines and cell and gene therapies require sophisticated R&D and production systems, causing the procurement and operations for GxP life sciences facilities to grow increasingly complex and challenging. Adding to that challenge, the Food and Drug Administration (FDA) now expects faster, easier access to even more data from life sciences facilities. Facilities management (FM) teams are on the front lines of ensuring greater uptime and regulatory compliance, and the stakes are high.
Integrated facilities management (IFM) is an effective solution to these challenges. By integrating FM functions and vendors into a centralized team, typically in partnership with a real estate services provider, you can mitigate compliance and operational risks, helping avoid costly delays, FDA citations, 483 inspection observations, and even safety or quality breaches. Download the following scenario to see how IFM differs from traditional FM when it comes to an FDA inspection.