Tag: sterilization validation

Data Lifecycle Management in CSV-Validated Systems

Data Lifecycle Management in CSV-Validated Systems Data Lifecycle Management in CSV-Validated Systems In the field of pharmaceuticals, effective data lifecycle management in computer system validation (CSV) is critical for ensuring compliance with strict regulatory requirements. This article provides a comprehensive,…

How to Review Electronic Records for Completeness and Accuracy

How to Review Electronic Records for Completeness and Accuracy How to Review Electronic Records for Completeness and Accuracy In the pharmaceutical industry, ensuring the integrity and reliability of electronic records is crucial to meeting regulatory standards. This article specifically addresses…

Using SCADA Data for Utility Equipment Validation

Using SCADA Data for Utility Equipment Validation Using SCADA Data for Utility Equipment Validation In the pharmaceutical industry, achieving a seamless and compliant sterilization validation process is critical. With increasing regulatory demands and advanced technologies, such as SCADA (Supervisory Control…

Utility Control Panel Qualification: Wiring, Relays, and Alarms

Utility Control Panel Qualification: Wiring, Relays, and Alarms Utility Control Panel Qualification: Wiring, Relays, and Alarms This article serves as a comprehensive step-by-step guide for quality assurance (QA), quality control (QC), validation, and regulatory teams involved in the sterilization validation…

CPV Template and Checklist for QA Teams

CPV Template and Checklist for QA Teams CPV Template and Checklist for QA Teams Continued Process Verification (CPV) is a critical component of process validation within the pharmaceutical industry. Emphasized by regulatory guidelines such as the FDA Process Validation Guidance…

How to Present CPV Data During Regulatory Audits

How to Present CPV Data During Regulatory Audits How to Present CPV Data During Regulatory Audits In the current regulatory landscape, the pharmaceutical industry faces stringent scrutiny regarding the implementation and effectiveness of Continued Process Verification (CPV) programs. This article…