Tag: Coding

Validation of Aggregation Systems for Multilevel Traceability

Validation of Aggregation Systems for Multilevel Traceability Validation of Aggregation Systems for Multilevel Traceability As pharmaceutical companies increasingly adopt complex aggregation systems for multilevel traceability, the need for robust computer system validation (CSV) becomes paramount. Ensuring compliance with regulatory standards…

GAMP5 Considerations for Serialization Software Systems

GAMP5 Considerations for Serialization Software Systems GAMP5 Considerations for Serialization Software Systems In the pharmaceutical industry, the integrity and security of product serialization systems are critical for compliance with regulatory mandates and for ensuring patient safety. Computer system validation (CSV)…

Human-Machine Interface (HMI) Validation in Coding Units

Human-Machine Interface (HMI) Validation in Coding Units Human-Machine Interface (HMI) Validation in Coding Units The role of Human-Machine Interfaces (HMIs) in the pharmaceutical industry, particularly in coding units, necessitates strict compliance with regulatory expectations and best practices. The validation of…

Case Study: Batch Recall Due to Serialization System Failure

Case Study: Batch Recall Due to Serialization System Failure Case Study: Batch Recall Due to Serialization System Failure This detailed article serves as a practical guide for pharmaceutical professionals focusing on computer system validation in pharmaceuticals. It aims to improve…

Real-Time Data Capture Validation on Packaging Lines

Real-Time Data Capture Validation on Packaging Lines Real-Time Data Capture Validation on Packaging Lines This article provides a comprehensive, step-by-step guide on the validation lifecycle for real-time data capture systems used on packaging lines in the pharmaceutical industry. Given the…

Regulatory Guidelines for Traceability and Coding Compliance

Regulatory Guidelines for Traceability and Coding Compliance Regulatory Guidelines for Traceability and Coding Compliance The regulatory landscape for traceability and coding compliance in the pharmaceutical industry emphasizes the necessity for robust validation processes, especially concerning computer systems. This tutorial will…

Software Validation for Serialization Control Systems

Software Validation for Serialization Control Systems Software Validation for Serialization Control Systems In the pharmaceutical industry, proper computer system validation (CSV) is crucial for ensuring compliance with regulatory requirements and quality standards. Serialization control systems represent a significant aspect of…

SOP for Label Reconciliation and Verification

SOP for Label Reconciliation and Verification SOP for Label Reconciliation and Verification In the pharmaceutical industry, ensuring compliance and proper validation of computer systems is critical for maintaining quality and safety standards. In line with regulatory requirements outlined by organizations…

Error-Proofing Labeling and Serialization Using Vision Systems

Error-Proofing Labeling and Serialization Using Vision Systems Error-Proofing Labeling and Serialization Using Vision Systems In the highly regulated pharmaceutical industry, ensuring the accuracy and reliability of labeling and serialization is paramount. This article outlines a comprehensive, step-by-step validation tutorial to…

Revalidation Requirements After Coding Format Changes

Revalidation Requirements After Coding Format Changes Revalidation Requirements After Coding Format Changes The implementation of coding format changes in pharmaceutical packaging systems is a critical area of the validation lifecycle. Incorporating changes in systems necessitates a comprehensive understanding of relevant…