Multimedia Life Sciences Quality + Compliance Exploring IT Infrastructure Qualification Practices for GMP Environments Imagine this: you put in a new firewall for your good manufacturing practices (GMP) facility. A few months later, you ...
Blog Post Life Sciences SAP + Technology The Transition to Computer System Assurance – What’s Next? The Food and Drug Administration has issued the draft guidance for Computer Software Assurance for Production and Quality System Software. ...
Blog Post Life Sciences Quality + Compliance Best Practices for Software Validation in Life Sciences Software validation, a standard practice in life sciences quality and compliance, has become even more critically important over the last ...
Blog Post Life Sciences Information Technology Preparing for the Shift from Computer Systems Validation to Computer Software Assurance Let’s explore the differences between Computer Systems Validation (CSV) and Computer Software Assurance (CSA): Tony is a truck driver, and ...
Case Study Biotech Consulting Services Veeva Vault QualityDocs and RIMS Implementation For several years, trends in modern medicine have been shifting towards promising treatments in cell and gene therapy. Backing these ...
Article Supply Chain Consulting Services McKesson Communicates Serialization & Aggregation Expectations to Suppliers In a letter this week to its suppliers, McKesson—the largest pharmaceutical distributor in the United States—addressed their expectations relating to ...
Blog Post Quality + Compliance Consumer Products Consumer Products Quality Systems Validation: You’re Not Alone Throughout this blog series, I have asked a number of Clarkston experts to discuss several different topics with respect to ...
Blog Post Quality + Compliance Consumer Products How to Make Quality Systems Validation Less Daunting As we have talked about through this series, by definition, Quality Systems Validation is the action of proving, in accordance with applicable ...
Blog Post Consumer Products Quality + Compliance Quality Systems Validation: The Right Way with the Right People To continue our series on Quality Systems Validation for the Consumer Products industry, I’ve asked Shashank Kadam to address some ...
Blog Post Consumer Products Quality + Compliance Quality Systems Validation Defined for the Consumer Products Industry Today, I’ve asked Nicole Taylor to discuss the critical components of quality systems validation for the Consumer Products industry. Nicole ...
Blog Post Consumer Products Health and Beauty Quality Systems Validation – Does it Apply to Consumer Products? Today, I’ve asked Jacqueline McCulloch to discuss quality systems validation for the Consumer Products industry. Jackie has more than 25 ...
Blog Post Consulting Services Quality + Compliance Validation for Serialization – The Longest Pole in the Tent As organizations plan their serialization initiative, I often find that the effort required to validate the complete solution is underestimated. ...
