Data Loggers and Monitoring Devices

Data Integrity and Part 11 Compliance for Digital Devices

Data Integrity and Part 11 Compliance for Digital Devices Data Integrity and Part 11 Compliance for Digital Devices Ensuring compliance with regulatory standards for digital devices in the pharmaceutical industry is crucial for maintaining data integrity, particularly during sterilisation validation…

Environmental Excursion Handling Based on Logger Output

Environmental Excursion Handling Based on Logger Output Environmental Excursion Handling Based on Logger Output In the pharmaceutical industry, proper management of environmental conditions during transportation and storage is paramount in ensuring product quality and compliance with regulatory standards. Understanding how…

Integration of Logger Data into CPV and QMS Systems

Integration of Logger Data into CPV and QMS Systems Integration of Logger Data into CPV and QMS Systems In the pharmaceutical industry, ensuring the integrity and compliance of processes such as sterilization validation is paramount. Central to this effort is…

Requalification Frequency for Data Loggers and Sensors

Requalification Frequency for Data Loggers and Sensors Requalification Frequency for Data Loggers and Sensors The validation of data loggers and sensors is a critical component in ensuring compliance with regulatory expectations and quality standards in the pharmaceutical sector. This article…

Linking Data Logger Results to Transport Release Decisions

Linking Data Logger Results to Transport Release Decisions Linking Data Logger Results to Transport Release Decisions Step 1: Understanding User Requirements Specification (URS) and Risk Assessment In any validation exercise, particularly in complex systems like data loggers, the first step…

Using Data Logger Alerts to Trigger CAPA or Investigation

Using Data Logger Alerts to Trigger CAPA or Investigation Using Data Logger Alerts to Trigger CAPA or Investigation Step 1: Understanding User Requirements Specification (URS) and Risk Assessment The foundation of any robust validation lifecycle begins with a clear understanding…

Trends in Monitoring Device Technology for Cold Chain

Trends in Monitoring Device Technology for Cold Chain Trends in Monitoring Device Technology for Cold Chain In the pharmaceutical industry, ensuring product integrity throughout the supply chain is paramount. One of the most critical aspects is the validation of computerized…

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,…

Using Wireless Monitoring Tools for Global Shipments

Using Wireless Monitoring Tools for Global Shipments Using Wireless Monitoring Tools for Global Shipments The use of wireless monitoring tools for global shipments is becoming increasingly essential in the pharmaceutical and biologics industries. Ensuring the integrity of products during transit…

Troubleshooting Incomplete or Lost Logger Data

Troubleshooting Incomplete or Lost Logger Data Troubleshooting Incomplete or Lost Logger Data In the pharmaceutical industry, ensuring data integrity during transport and storage is paramount. Data loggers are essential in monitoring environmental conditions to maintain product quality. However, data integrity…