computer system validation in pharma – Page 2

Documenting Calculations and Raw Data Sources Transparently

Documenting Calculations and Raw Data Sources Transparently Documenting Calculations and Raw Data Sources Transparently In the pharmaceutical industry, the validation of computer systems is a critical step in ensuring data integrity, compliance, and regulatory adherence. This article provides a comprehensive…

How to Respond to Data Integrity Observations in FDA Audits

How to Respond to Data Integrity Observations in FDA Audits How to Respond to Data Integrity Observations in FDA Audits Step 1: Understanding the Regulatory Landscape The foundation of effective computer system validation (CSV) in the pharmaceutical industry begins with…

How the VMP Fits Into the Pharma Validation Lifecycle

How the VMP Fits Into the Pharma Validation Lifecycle How the VMP Fits Into the Pharma Validation Lifecycle In today’s complex regulatory environment, the importance of a robust Validation Master Plan (VMP) cannot be overstated. It serves as the backbone…

VMP Alignment with Site Validation Policy and Corporate Guidelines

VMP Alignment with Site Validation Policy and Corporate Guidelines VMP Alignment with Site Validation Policy and Corporate Guidelines In the realm of pharmaceuticals, the alignment of the Validation Master Plan (VMP) with site validation policies and corporate guidelines is paramount.…

Benchmarking VMP Compliance Against FDA/EMA Warning Letters

Benchmarking VMP Compliance Against FDA/EMA Warning Letters Benchmarking VMP Compliance Against FDA/EMA Warning Letters The capacity for pharmaceutical organizations to align with regulatory expectations is paramount, especially in the domain of computer system validation in pharma. This article provides a…

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…

Equipment Qualification Strategy During Tech Transfer Projects

Equipment Qualification Strategy During Tech Transfer Projects Equipment Qualification Strategy During Tech Transfer Projects 1. Understanding User Requirements Specification (URS) & Risk Assessment Equipment qualification is essential in ensuring that systems used in the pharmaceutical industry operate consistently within specified…

Acceptance Criteria for Repeating Failed OQ or PQ Tests

Acceptance Criteria for Repeating Failed OQ or PQ Tests Acceptance Criteria for Repeating Failed OQ or PQ Tests In the context of computer system validation in pharma, the execution of Operational Qualification (OQ) and Performance Qualification (PQ) protocols is critical…