Tag: computer validation

Documentation Requirements for Monitoring Devices in Validation

Documentation Requirements for Monitoring Devices in Validation Documentation Requirements for Monitoring Devices in Validation In the pharmaceutical and biologics industries, ensuring the integrity and reliability of monitoring devices is critical for compliance with regulatory standards. This article provides a comprehensive,…

Print Registration and Barcode Validation in Strip Packs

Print Registration and Barcode Validation in Strip Packs Print Registration and Barcode Validation in Strip Packs The validation of print registration and barcode systems in pharmaceutical strip packing is critical to ensure product integrity and compliance with regulatory requirements. This…

HVAC Performance and Seasonal Variation in Monitoring Results

HVAC Performance and Seasonal Variation in Monitoring Results HVAC Performance and Seasonal Variation in Monitoring Results Step 1: User Requirement Specification (URS) and Risk Assessment The foundation of a robust validation process is the User Requirement Specification (URS). This document…

Traceability in Computer System Validation Documentation

Traceability in Computer System Validation Documentation Traceability in Computer System Validation Documentation In the pharmaceutical industry, computer system validation (CSV) is an essential process to ensure compliance with regulatory expectations regarding data integrity, reliability, and security. It is necessary to…

How to Link Client-Specific Protocols to a Site VMP

How to Link Client-Specific Protocols to a Site VMP How to Link Client-Specific Protocols to a Site VMP In the pharmaceutical industry, establishing a comprehensive Validation Master Plan (VMP) is critical for ensuring compliance with regulatory requirements. This article serves…

Role-Based Access Controls for Data Security in CSV

Role-Based Access Controls for Data Security in CSV Role-Based Access Controls for Data Security in CSV In the pharmaceutical and biologics sectors, ensuring the integrity of data through robust validation processes is critical. Computerized system validation (CSV) is a fundamental…

Utility Qualification Acceptance Criteria and Tolerances

Utility Qualification Acceptance Criteria and Tolerances Utility Qualification Acceptance Criteria and Tolerances Utility qualification is a critical aspect of computer validation within the pharmaceutical industry, ensuring that the systems and processes used in the manufacturing and quality control of products…

Role of LIMS and QMS in CPV Automation

Role of LIMS and QMS in CPV Automation Role of LIMS and QMS in CPV Automation In the pharmaceutical and biologics sectors, compliance with strict regulatory standards is crucial for quality assurance and product integrity. Continued Process Verification (CPV) plays…