Computer System Validation (CSV)

Cybersecurity and CSV: Protecting Cloud-Based Pharma Data

Cybersecurity and CSV: Protecting Cloud-Based Pharma Data Cybersecurity and CSV: Protecting Cloud-Based Pharma Data Step 1: User Requirement Specification (URS) and Risk Assessment Establishing a foundation for robust process validation in pharma begins with the creation of a comprehensive User…

SOP Template for Cloud-Based System Lifecycle Management

SOP Template for Cloud-Based System Lifecycle Management SOP Template for Cloud-Based System Lifecycle Management In the highly regulated pharmaceutical industry, adhering to stringent guidelines is paramount. This comprehensive tutorial on pharmaceutical process validation (PPV) serves as a guide to help…

Managing Software Upgrades in a SaaS CSV Environment

Managing Software Upgrades in a SaaS CSV Environment Managing Software Upgrades in a SaaS CSV Environment In the dynamic landscape of the pharmaceutical industry, managing software upgrades in a Software as a Service (SaaS) environment poses unique challenges, particularly in…

Vendor-Supplied IQ/OQ: How Much Is Enough?

Vendor-Supplied IQ/OQ: How Much Is Enough? Vendor-Supplied IQ/OQ: How Much Is Enough? Process validation in the pharmaceutical industry is a critical aspect that ensures products are consistently produced and controlled according to quality standards. A fundamental component of this validation…

Cloud CSV Audit Checklist: What Regulators Expect

Cloud CSV Audit Checklist: What Regulators Expect Cloud CSV Audit Checklist: What Regulators Expect In the complex landscape of pharmaceutical manufacturing and the ever-expanding role of cloud computing, effective validation becomes paramount. This comprehensive guide aims to provide a step-by-step…

Validating Disaster Recovery for Cloud Platforms

Validating Disaster Recovery for Cloud Platforms Validating Disaster Recovery for Cloud Platforms In the contemporary landscape of the pharmaceutical industry, the utilization of cloud platforms has surged, leading to the imperative necessity for a robust disaster recovery (DR) validation framework.…