Read our updated trends report here: 2025 Quality and Compliance Trends Clarkston’s team of life sciences consultants have highlighted the ...

It’s critical for pharmaceutical, medical device, and biotech companies to always be ready for an announced or unannounced inspection by ...

The Remote Regulatory Assessment (RRA) was originally introduced in an April 2021 Guidance for Industry as a Remote Interactive Evaluation ...

It’s critical to have a good understanding of the processes used within your company, but how do we best document ...

Quality management has come a long way since the days of simply inspecting finished products for defects. With the advent ...

The FDA has recently updated two compliance program guides addressing PAI inspections (7346.832) and routine GMP surveillance inspections (7356.002). This ...

The benefits to having a Quality Management System (QMS) are generally well known and understood. Having a quality framework throughout ...

When organizations implement metrics, there is often the urge to track and trend any and every data point. The presence ...

Deciding when to invest in a QMS (Quality Management System) can be a time-consuming endeavor. It’s important to choose the ...

Choosing the right Quality Management System (QMS) software can change the way organizations do business. At times, organizations are quick ...

A quality system (QS) consists of processes that are implemented and documented to ensure that product quality is reproduceable, consistent, ...

Change management is defined in ICH Q10 as a systematic approach to proposing, evaluating, approving, implementing, and reviewing changes.  A disciplined ...