An ISO audit can feel like a daunting task but one that’s well-worth the challenge as gaining ISO9001 or ISO13485 ...

Clear standard operating procedures (SOPs) are essential to the successful operation of an organization in order to create consistency in ...

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 ...

Clear Standard Operating Procedures (SOPs) are essential to the successful quality operations of an organization in order to create consistency ...

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