Tag: computer system validation fda

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…

Tooling Qualification for Format Parts in Blister Machines

Tooling Qualification for Format Parts in Blister Machines Tooling Qualification for Format Parts in Blister Machines In the pharmaceutical industry, the validation of packaging systems, including blister machines, is crucial for ensuring product integrity, efficacy, safety, and compliance with regulatory…

Integration of HVAC Data into QMS and CPV Systems

Integration of HVAC Data into QMS and CPV Systems Integration of HVAC Data into QMS and CPV Systems The integration of Heating, Ventilation, and Air Conditioning (HVAC) data into Quality Management Systems (QMS) and Continued Process Verification (CPV) systems is…

Using Validation IDs and Codes for Document Mapping

Using Validation IDs and Codes for Document Mapping Using Validation IDs and Codes for Document Mapping In the pharmaceutical industry, the importance of efficient and accurate documentation cannot be overstated. Ensuring traceability, linking, and cross-referencing of validation documents is critical…

VMP Format Adaptation for API vs Drug Product Sites

VMP Format Adaptation for API vs Drug Product Sites VMP Format Adaptation for API vs Drug Product Sites The validation process within pharmaceutical manufacturing is an essential step to ensure compliance with regulatory expectations and to guarantee product quality. The…

Using Audit Trail Printouts as Evidence in Regulatory Inspections

Using Audit Trail Printouts as Evidence in Regulatory Inspections Using Audit Trail Printouts as Evidence in Regulatory Inspections Audit trails play a pivotal role in maintaining data integrity and ensuring compliance during regulatory inspections. For Quality Assurance (QA) and Quality…

Qualification of Nitrogen and CO₂ Gas Supply Equipment

Qualification of Nitrogen and CO₂ Gas Supply Equipment Qualification of Nitrogen and CO₂ Gas Supply Equipment The qualification of utility equipment, particularly gas supply equipment like Nitrogen and CO₂, is pivotal in ensuring consistent quality and compliance in pharmaceutical manufacturing…

Building Dashboards for CPV Visualization (Excel + Power BI)

Building Dashboards for CPV Visualization (Excel + Power BI) Building Dashboards for CPV Visualization (Excel + Power BI) Continued Process Verification (CPV) is a critical aspect of process validation that ensures that processes remain in a state of control throughout…