Navigating the maze of laboratory regulatory compliance can feel overwhelming. Yet, it's a journey every lab must undertake to ensure reliable results and build a solid reputation in the industry.
Whether it's GxP, ISO 17025, or 21 CFR Part 11, understanding these standards is crucial. Our guide breaks down what each regulation entails and how they impact your daily operations.
We'll walk you through the steps to get certified—from organizing your documentation and setting up audit trails to conducting internal audits and preparing for inspections.
But there's more.
We delve into common pitfalls that can trip up even the most diligent labs. You'll discover why relying on pen and paper might be putting your lab at risk.
Learn about key quality control metrics you should be tracking and how modern software solutions like LIMS and QMS—especially integrated platforms like QBench—can simplify compliance and boost efficiency.
With practical tips and actionable insights, this guide equips you to navigate regulatory requirements confidently. Let us help you turn compliance from a hurdle into a stepping stone for your lab's success.