Tag: Computer System Validation (CSV)

Building a Data Governance Program for GxP Environments

Building a Data Governance Program for GxP Environments Building a Data Governance Program for GxP Environments In the pharmaceutical and biologics industries, a robust data governance program is essential for ensuring compliance with Good Manufacturing Practices (GMP) and regulations set…

Common Data Integrity Violations Found in CSV Audits

Common Data Integrity Violations Found in CSV Audits Common Data Integrity Violations Found in CSV Audits In the highly regulated pharmaceutical and biologics industries, ensuring the integrity of data captured during the computer system validation (CSV) process is paramount. With…

Handling Data Integrity Deviations and CAPA Implementation

Handling Data Integrity Deviations and CAPA Implementation Handling Data Integrity Deviations and CAPA Implementation Data integrity is a critical component of validation in pharmaceutics, especially within the realms of computer systems validation and compliance with regulations. This step-by-step tutorial aims…

Real-Time vs Historical Audit Trails: Regulatory Expectations

Real-Time vs Historical Audit Trails: Regulatory Expectations Real-Time vs Historical Audit Trails: Regulatory Expectations Step 1: Understanding the Need for Validation in Pharmaceutical Industry The validation in pharmaceutical industry is critical to ensure product quality, efficacy, and safety. Regulatory bodies…

How to Detect and Report Data Integrity Breaches

How to Detect and Report Data Integrity Breaches How to Detect and Report Data Integrity Breaches Data integrity is a critical component in the validation lifecycle of pharmaceutical processes. This article outlines a comprehensive, step-by-step tutorial for the detection and…

Audit Trail Review: Frequency, Documentation, and Responsibility

Audit Trail Review: Frequency, Documentation, and Responsibility Audit Trail Review: Frequency, Documentation, and Responsibility In the context of pharmaceutical validation, maintaining data integrity is paramount. Audit trails are key components in computerized systems used within the pharmaceutical industry. This article…

ALCOA+ Principles and Their Role in Data Integrity

ALCOA+ Principles and Their Role in Data Integrity ALCOA+ Principles and Their Role in Data Integrity In the modern pharmaceutical landscape, maintaining data integrity is paramount, especially concerning validation in the pharmaceutical industry. The ALCOA+ principles provide a comprehensive framework…

How to Validate Audit Trail Functionality in Pharma Systems

How to Validate Audit Trail Functionality in Pharma Systems How to Validate Audit Trail Functionality in Pharma Systems In the ever-evolving landscape of the pharmaceutical industry, ensuring data integrity and compliance with regulatory requirements has become paramount. A critical component…

Part 11 Validation for LIMS, SCADA, and MES Systems

Part 11 Validation for LIMS, SCADA, and MES Systems Part 11 Validation for LIMS, SCADA, and MES Systems In the pharmaceutical industry, ensuring compliance with regulations and maintaining data integrity is paramount. The validation process for computer systems such as…

Training Requirements Under 21 CFR Part 11

Training Requirements Under 21 CFR Part 11 Training Requirements Under 21 CFR Part 11 In the rapidly evolving landscape of the pharmaceutical industry, rigorous compliance with regulatory standards is essential. The implementation and validation of computer systems governed by 21…