Articles tagged with “quality-systems”

CSV to CSA: Understanding FDA's New Validation Guidance

Analyze the transition from CSV to FDA's Computer Software Assurance (CSA). This guide details risk-based validation strategies and compliance impacts.

30 min read

2/6/2026

computer software assurance csv vs csa fda guidance risk-based validation computer system validation gxp compliance software testing quality systems medical device software pharma validation

RegTech Adoption for Emerging Biotechs: Licensing Models

Examines RegTech adoption challenges for emerging biotechs, focusing on cost, scalability, and AI-driven compliance. Covers flexible licensing, usage-based pricing, deferred-value models, and the latest platform innovations from Veeva Vault Basics and beyond.

40 min read

8/6/2025

regtech biotechnology regulatory compliance licensing models emerging biotech quality systems deferred-value models

Pharmaceutical Plant Development: From Concept to Commissioning

Learn to build a pharmaceutical manufacturing plant from concept through commissioning. This guide covers planning, regulatory compliance, design, equipment, quality, validation, and approval.

120 min read

5/22/2025

pharmaceutical plant facility development pharma manufacturing regulatory compliance quality systems validation feasibility study project execution site selection equipment