How to Scope and Budget a CSV Project: 7 Cost Drivers That Matter
A CSV budget holds up when every line item traces to a defined deliverable, a system risk or an implementation dependency. Here are the 7 cost drivers to scope before kickoff. [...]
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Tag: CSA
CSA
FDA CSA Guidance 2026: What Changed for Risk-Based Software Assurance?
The U.S. Food and Drug Administration (FDA) updated its Computer Software Assurance (CSA) guidance on February 3, 2026, to align with the Quality Management System Regulation (QMSR), which took effect the previous day. The revised guidance, Computer Software Assurance for Production and Quality Management System Software, replaces guidance issued in [...]
Data Integrity in Pharma: From ALCOA+ to Practical Controls
Data integrity remains at the forefront of global regulatory inspections. Health authorities—including the US FDA, EMA, Health Canada, and PMDA—continue to issue warning letters and non-compliance notices for data management failures in pharmaceutical operations. Achieving sustainable compliance requires moving beyond memorizing the ALCOA+ framework to embedding practical, automated controls within [...]