Your aging quality management system (QMS) and the problems caused by it are keeping you up at night. You would ...

The wait and suspense for the United States Food and Drug Administration’s (FDA) plans to harmonize and modernize the way ...

The benefits of a quality management system (QMS) to an organization are generally well understood among quality professionals today. Using ...

LIMS data integrity not only impacts the efficacy and efficiency of the LIMS platform, it has cascading effects on regulatory ...

A strategic approach to LIMS design is critical to realize the full benefits of any LIMS platform. Not only will ...

A quality philosophy that focuses on a business approach to compliance versus a compliance approach to business is key to ...

LIMS implementations are often viewed as a challenging journey due to the investment of cost, commitment of resources and competing ...

The client develops and manufactures pharmaceutical products for a wide range of medical disciplines. Specifically, the Vaccine Research and Development ...

As companies face the challenges of a slowdown due to COVID-19, this may be the perfect time to review the ...

Laboratory Information Management System (LIMS) implementations can be challenging due to the cost, commitment of resources, and other competing priorities ...

You are in the middle of an FDA inspection and a significant issue just surfaced.  How you handle the situation ...

In September of this year, the FDA plans to release guidance on the transition from the traditional concepts of Computer ...