Tag: computer systems validation

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…

Revalidation of Blister Machines After Change in Format

Revalidation of Blister Machines After Change in Format Revalidation of Blister Machines After Change in Format Revalidation of blister packaging machines is a critical process in ensuring the continued quality, safety, and efficacy of pharmaceutical products. With the continual evolution…

Using EMS Data to Support Continued HVAC Validation

Using EMS Data to Support Continued HVAC Validation Using EMS Data to Support Continued HVAC Validation The integration of Environmental Monitoring Systems (EMS) data within the HVAC validation framework is critical for maintaining compliance with regulatory requirements in the pharmaceutical…

How to Create a VMP That Cross-References Validation Elements

How to Create a VMP That Cross-References Validation Elements How to Create a VMP That Cross-References Validation Elements A comprehensive Validation Master Plan (VMP) is critical for ensuring compliance and effective traceability in the realm of computer systems validation (CSV).…

Coordinating VMP Revisions Across Client Products

Coordinating VMP Revisions Across Client Products Coordinating VMP Revisions Across Client Products Step 1: Understanding User Requirements Specification (URS) and Risk Assessment The first step in the validation lifecycle is to establish a comprehensive User Requirements Specification (URS) that clearly…

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…

How to Perform Flow Rate and Pressure Verification in Utilities

How to Perform Flow Rate and Pressure Verification in Utilities How to Perform Flow Rate and Pressure Verification in Utilities In the pharmaceutical industry, the validation of utility systems such as water, compressed air, and gases is critical for ensuring…

Linking CPV to Product Quality Complaints and Deviations

Linking CPV to Product Quality Complaints and Deviations Linking CPV to Product Quality Complaints and Deviations Continued Process Verification (CPV) is integral to ensuring consistent product quality throughout the product lifecycle. This tutorial provides a comprehensive, step-by-step guide on how…