Computer System Validation in Pharma 2025 Guide
Computer System Validation in pharma keeps your digital systems reliable, compliant, and inspection ready. In this practical CSV guide for [year], you learn core regulations (21 CFR Part 11, EU Annex 11, GAMP 5), step-by-step lifecycle activities, documentation expectations, and job-relevant skills so you protect data integrity and support safe, efficient pharmaceutical operations.
ICH Guidelines for Pharmacovigilance: Complete E2 Series Guide (2025)
The ICH guidelines for pharmacovigilance explain how drug-safety teams collect, evaluate, and report adverse events across the product lifecycle. This guide walks you through the E2A–E2F series, shows how they support global safety standards, and explains how they link to EMA and FDA rules so you stay compliant and protect patients.
