Blog Post Life Sciences Pharma The Challenge at the Final Mile of DQSA When the Drug Quality and Security Act (DQSA) was passed in 2013, it mandated that full compliance with electronic data ...
Case Study Quality + Compliance Biotech Organizational Change Management for Global Veeva Implementation This client develops and produces treatment for life-threatening diseases around the world. In addition to antiviral and antiretroviral therapy used ...
Case Study Life Sciences Information Technology Managing the LIMS Vendor Selection Process for a Contract Testing Lab A global leader in third-party testing services sought out Clarkston’s experience to help them select a Laboratory Information Management System ...
Case Study Life Sciences Biotech 3PL and Serialization Vendor Selection for a Biopharmaceutical Company Clarkston Consulting recently partnered with a client for a vendor selection project for 3PL and serialization capabilities. This client is a virtual biopharmaceutical company that focuses on developing ...
Blog Post Organizational Performance Consumer Products SOP Best Practices to Strengthen SOP Maturity Clear Standard Operating Procedures (SOPs) are essential to the successful quality operations of an organization in order to create consistency ...
Blog Post Consumer Products Food and Beverage Planning for the Baby Food Safety Act of 2021 Current State in Baby Food Industry Over the past year, multiple voluntary baby food recalls, due to arsenic levels, have ...
Case Study Biotech Pharma Labware BioLIMS Migration for a Biotechnology Company Clarkston successfully completed a Labware BioLIMS migration for a biotechnology company. This client focuses on producing therapies for the treatment ...
Case Study Pharma Quality + Compliance Managing PAI and BIMO Inspection Readiness Clarkston recently partnered with a client on a PAI and BIMO inspection readiness project. This client is a biopharmaceutical company ...
Blog Post Food and Beverage Consumer Products The New Era of Smarter Food Safety In April 2019, the FDA released the New Era of Smarter Food Safety initiative, which outlines their approach around food safety over ...
Blog Post Food and Beverage Quality + Compliance Food Quality Assurance in the Age of Tech-Enabled Traceability This food quality assurance piece is original content from FoodLogiQ and originally published on their website. Learn about the role ...
Case Study Quality + Compliance Biotech Delivery of a Global, Harmonized LIMS System During COVID-19 After being engaged for a site deployment of the project, Clarkston was asked to take over the program as the ...
Blog Post Quality + Compliance Consumer Products Making CPG Quality Management Consumer-Centric While compliance is often seen as a hindrance to market and product agility, CPG quality management and compliance align company ...
