Blog Post Quality + Compliance Life Sciences Applying Computer Software Assurance (CSA) to Manufacturing Software In this piece, we outline considerations for applying computer software assurance (CSA ) to manufacturing software. Traditionally, validating computer software has ... Download PDF
Blog Post AMS Quality + Compliance Exploring the Benefits of a CSV Managed Services Partner Ongoing Computer System Validation (CSV) / Computer System Assurance (CSA) activities are critical in biopharma to ensure that GxP systems remain fit for intended use throughout ...
Case Study Life Sciences Biotech Transitioning from CSV to CSA for a Biotechnology Company Clarkston Consulting recently partnered with a biotechnology client in their transition from CSV to CSA. Read a synopsis of the ... Download PDF
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 ... Download PDF
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 The Food and Drug Administration has issued the draft guidance for Computer Software Assurance for Production and Quality System Software.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 ... Download PDF
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 ...
