A Risk-Based Approach to GxP Computer Systems Validation Using Critical Thinking
Computer system validation is a key part of meeting regulatory requirements—how can you best ensure that your systems are compliant?
Regulations
Fielding Questions about Data Integrity from Regulatory Inspectors
Streamline interactions with inspectors by taking steps to minimize errors, writing comprehensive SOPs, and more
Book Review: "Building a Cannabis Testing Laboratory" by Javier Diaz
A useful guide for those starting the cannabis testing journey
Safety Considerations When Working Near Cryogenic Liquids
Key considerations for the safe use of cryogenic liquids
Developing a Robust Cleaning Validation Process
A proper cleaning validation lifecycle minimizes risks to product quality and ensures regulatory compliance
Three Reasons Why You Need a Chemical Inventory Management System
Forgoing a proper chemical inventory management platform will only increase risk and waste money
An Overview of Ultrasensitive Trace Metal Analysis
Advanced techniques overcome challenges with ultra-low detection levels
How to Prepare for a FDA GxP Inspection
Inspection outcomes depend not only on clinical factors but how you handle the inspection process
Protecting Your Lab’s Data Integrity
Evaluating instruments in the lab
Managing the Integrity of Data
Lab managers must refocus their efforts on managing data due to increased regulatory agency activity