Product Hub: Creating centralised control for a decentralised approach

Maintaining the long-term safety of a manufacturing environment while meeting the demands of compliance is a microbial quality control manager’s top priority…

The need to investigate out-of-specification (OOS) results continues to be one of the most commonly observed current good manufacturing practice (cGMP) issues during quality control laboratory inspections. Having access to accurate, relevant and reliable data is therefore essential to support confident decisions on product quality. Moreover, current FDA warning letters and new global guidance documents outline the increasing requirements regarding data integrity, alerting many organisations to existing deficiencies in their data and reporting. Charles River Cortex™ enables users to effortlessly improve their compliance status. With the growing volume of quantitative Limulus amebocyte lysate (LAL) tests being performed today, electronic data generation is now an expectation, rather than the exception. It can be challenging to securely manage data and maintain oversight of multiple systems distributed throughout a facility, but advances in technology have made it possible to do just that.