Tag: computer system validation in pharma

Deviation Trending in Equipment Qualification Reports

Deviation Trending in Equipment Qualification Reports Deviation Trending in Equipment Qualification Reports The process of equipment qualification is a critical component of the pharmaceutical validation lifecycle that ensures systems and processes are designed, implemented, and operated correctly to produce consistent…

Lifecycle Approach to Process Validation: ICH and FDA Guidance

Lifecycle Approach to Process Validation: ICH and FDA Guidance Lifecycle Approach to Process Validation: ICH and FDA Guidance Understanding the Validation Lifecycle The validation lifecycle in pharmaceutical manufacturing is a rigorous process designed to ensure that systems, processes, and products…

Process Validation Document Lifecycle Management

Process Validation Document Lifecycle Management Process Validation Document Lifecycle Management In the highly regulated pharmaceutical industry, effective process validation is crucial to ensure that products are safely manufactured to meet quality standards. This comprehensive tutorial will guide professionals through the…

Data Integrity Considerations in Validation Protocols

Data Integrity Considerations in Validation Protocols Data Integrity Considerations in Validation Protocols Step 1: User Requirements Specification (URS) and Risk Assessment The first step in the validation lifecycle is the development of the User Requirements Specification (URS). The URS outlines…