Tag: Computer System Validation (CSV)

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.…

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…

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…

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…

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…

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…

Data Integrity Considerations in Multi-Tenant Cloud Systems

Data Integrity Considerations in Multi-Tenant Cloud Systems Data Integrity Considerations in Multi-Tenant Cloud Systems In the pharmaceutical industry, ensuring data integrity throughout the validation lifecycle is paramount. As organizations increasingly migrate to multi-tenant cloud systems, understanding the intricacies of process…

Hybrid Cloud Models and Validation Complexity

Hybrid Cloud Models and Validation Complexity Hybrid Cloud Models and Validation Complexity In the ever-evolving landscape of the pharmaceutical and medical device industries, the integration of cloud technologies presents both opportunities and challenges, especially regarding validation processes. This comprehensive guide…

Validating Backup and Restore in SaaS Systems

Validating Backup and Restore in SaaS Systems Validating Backup and Restore in SaaS Systems The validation of backup and restore functionalities within Software as a Service (SaaS) systems is critical for ensuring data integrity and regulatory compliance in the pharmaceutical…

Electronic Record Control in Cloud-Based Platforms

Electronic Record Control in Cloud-Based Platforms Electronic Record Control in Cloud-Based Platforms In the evolving landscape of pharmaceutical and medical device manufacturing, electronic record control in cloud-based platforms has become instrumental in ensuring compliance and data integrity. This article presents…