Tag: Computer System Validation (CSV)

How to Manage Service Level Agreements in Cloud CSV

How to Manage Service Level Agreements in Cloud CSV How to Manage Service Level Agreements in Cloud CSV Cloud-based Computer System Validation (CSV) has become a pivotal element for the pharmaceutical and medical devices industry, particularly as organizations migrate to…

Data Residency and Access in SaaS-Based Validation

Data Residency and Access in SaaS-Based Validation Data Residency and Access in SaaS-Based Validation 1. Understanding the Validation Lifecycle The validation lifecycle in the pharmaceutical industry, especially concerning process validation medical device, is structured into sequential steps that align closely…

Qualifying Cloud Vendors for Pharmaceutical Use

Qualifying Cloud Vendors for Pharmaceutical Use Qualifying Cloud Vendors for Pharmaceutical Use In the modern pharmaceutical landscape, the reliance on cloud-based systems is growing significantly. As organizations transition to these platforms for critical operations, ensuring compliance and validation aligns with…

GAMP 5 Guidance for Cloud-Based System Validation

GAMP 5 Guidance for Cloud-Based System Validation GAMP 5 Guidance for Cloud-Based System Validation In the context of pharmaceutical development, computer system validation plays a pivotal role in ensuring compliance with regulatory requirements, particularly in a cloud-based environment. As organizations…

Cloud CSV Explained: Strategies for Hosted Systems

Cloud CSV Explained: Strategies for Hosted Systems Cloud CSV Explained: Strategies for Hosted Systems The advent of cloud computing has significantly transformed various sectors, including the pharmaceutical industry. As organizations strive to comply with rigorous regulatory standards while leveraging the…

How to Validate SaaS Systems for GxP Compliance

How to Validate SaaS Systems for GxP Compliance How to Validate SaaS Systems for GxP Compliance In today’s rapidly evolving pharmaceutical landscape, the validation of Software as a Service (SaaS) systems has emerged as a critical procedure for ensuring good…

Spreadsheet Template Library for Quality and Manufacturing

Spreadsheet Template Library for Quality and Manufacturing Spreadsheet Template Library for Quality and Manufacturing In the pharmaceutical industry, the integrity and accuracy of data are paramount to ensure compliance with regulatory requirements. This necessitates a robust framework for computer system…

GAMP 5 Approach for Configurable Software Validation

GAMP 5 Approach for Configurable Software Validation GAMP 5 Approach for Configurable Software Validation In the ever-evolving pharmaceutical industry, the importance of software validation cannot be overstated. Particularly, computer system validation (CSV) serves a critical role in ensuring that software…

Common FDA 483s Related to Software Validation

Common FDA 483s Related to Software Validation Common FDA 483s Related to Software Validation Step 1: Understanding User Requirements Specification (URS) and Risk Assessment The foundation of effective computer system validation in pharma begins with a well-defined User Requirements Specification…

Spreadsheet Change Control SOP Template

Spreadsheet Change Control SOP Template Spreadsheet Change Control SOP Template In today’s pharmaceutical environment, the efficacy of computer systems plays a critical role in maintaining compliance and ensuring product quality. This article outlines a comprehensive step-by-step approach to computer system…