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CSV in 2026: Computer System Validation for GMP Compliance

Computer system validation in pharma helps companies protect electronic records, control GxP risks, and maintain compliance throughout the validation lifecycle. This guide explains risk-based testing, audit trail review, access control, change control, and inspection-ready evidence.
  • Blog, Validation and Qualification
Pharmaceutical quality specialist reviewing a GxP dashboard for computer system validation in pharma, including audit trail review, access control, testing, and change control.

AI Agents Enter Regulated Workflows; Penn Medicine Starts a New Healthcare Shift – Copy

Compass Pathways has reported new six-month Phase III data showing that its psilocybin-based therapy, COMP360, continued to provide durable clinical benefits for patients with treatment-resistant depression. While the efficacy results attracted attention, the announcement also moves the therapy closer to
  • News
COMP360 Nears FDA Approval; Validation Requirements May Soon Change

CSV Documentation in 2026: GMP Compliance, Data Integrity, and Inspection Readiness

This article explains how CSV Documentation supports GMP compliance in computerized systems, focusing on validation traceability, IQ OQ PQ documentation, and data integrity requirements aligned with FDA 21 CFR Part 11 and EU Annex 11 expectations.
  • Blog, Validation and Qualification
Pharmaceutical validation documentation workflow for Computer System Validation (CSV) in GMP computerized systems, highlighting validation traceability matrix, IQ OQ PQ documentation, and compliance with GAMP 5 validation and data integrity standards.