Case Study Organizational Performance Quality + Compliance Project Management for Veeva eQMS Implementation Clarkston recently completed a Veeva eQMS Implementation project for a biopharmaceutical company. This client focuses on discovering, acquiring, developing, and ...
Blog Post Life Sciences Quality + Compliance Four Considerations for Managing Product Quality Complaints Receiving product quality complaints is inevitable. The key to navigating product quality complaints, however, is establishing a robust product quality ...
Blog Post Consulting Services Quality + Compliance What Your Company Needs to Know About Preparing for an FDA Inspection The FDA has recently updated two compliance program guides addressing PAI inspections (7346.832) and routine GMP surveillance inspections (7356.002). This ...
Case Study Life Sciences Quality + Compliance Computer System Validation to Computer System Assurance Clarkston recently completed an outside-in perspective to identify opportunities for computer system validation (CSV) simplification and alignment to the anticipated ...
Blog Post Quality + Compliance Research + Development Preparing Your QMS to Enable the Lab of the Future Accelerated by the demands of COVID-19, organizations have continued to increase their investments in laboratory technologies and strategies, often aiming ...
Blog Post Quality + Compliance Life Sciences What You Need to Know About a QMS Audit The benefits to having a Quality Management System (QMS) are generally well known and understood. Having a quality framework throughout ...
Blog Post Quality + Compliance Life Sciences Developing QMS Metrics to Share With Your Leadership Team When organizations implement metrics, there is often the urge to track and trend any and every data point. The presence ...
Blog Post Life Sciences Quality + Compliance When to Invest in a QMS Deciding when to invest in a QMS (Quality Management System) can be a time-consuming endeavor. It’s important to choose the ...
Blog Post Quality + Compliance Life Sciences Considerations for Selecting a Quality Management System (QMS) Software Choosing the right Quality Management System (QMS) software can change the way organizations do business. At times, organizations are quick ...
Blog Post Pharma Consulting Services Enabling Safety and Sustainability with Drug Take Back Programs There are a number of regulations in the pharmaceutical industry surrounding safe practices for drug security and traceability along the ...
Blog Post Life Sciences Data + Analytics Who Do You Need on Your Quality Systems Team? A quality system (QS) consists of processes that are implemented and documented to ensure that product quality is reproduceable, consistent, ...
Blog Post Retail Data + Analytics Understanding the Emerging Demands for Retail Traceability Earlier this year, the New York State Legislature introduced the New York Fashion Sustainability and Social Accountability Act – a ...
