Since 2022, the FDA has issued more than 600 warning letters for violations of GxP requirements. Regardless of the origin – poor documentation, incorrect data collection, or incomplete training – the cost of a warning letter for noncompliance can derail a manufacturing operation.

In the lab, leaders are laser-focused on maintaining compliance. With existing complex system infrastructures and heavy reliance on manual test execution, the manufacturing lab has an opportunity to streamline operations for reduced risk and increased efficiency. Positive change is underway as the industry moves to improve lab processes and enable more connected, seamless, and automated ways of working.

These changes are not just an incremental improvement but a necessary shift in the way labs operate to stay competitive in today’s market. The move towards digital transformation in the lab is becoming increasingly vital, and staying ahead of compliance issues is just one part of the equation. Companies that adopt these modern methods will not only avoid costly compliance issues but will also drive overall business agility and innovation.

Three pillars that can increase lab efficiency include bringing test execution and sample management data onto a single digital platform, improving right first time by having procedure documents and execution in the same system, and enabling review by exception. These advancements can drive productivity while making lab data available much faster, improvements that can keep product release on track.