Tag: computer system validation in pharmaceutical industry

Change Control During Qualification Execution: Guidelines

Change Control During Qualification Execution: Guidelines Change Control During Qualification Execution: Guidelines Effective change control is an essential component of computer system validation in the pharmaceutical industry. It ensures that any modifications made during qualification and validation processes do not…

How to Reference Related SOPs in a Validation Protocol

How to Reference Related SOPs in a Validation Protocol How to Reference Related SOPs in a Validation Protocol Step 1: Understanding User Requirements Specification (URS) & Risk Assessment The User Requirements Specification (URS) serves as the foundation for any validation…

How to Review and Approve Validation Documents in QA

How to Review and Approve Validation Documents in QA How to Review and Approve Validation Documents in QA Validation within the pharmaceutical industry is a critical topic, especially in the context of computer systems that support manufacturing, quality control, and…

Handling Deviations in Validation Protocols and Reports

Handling Deviations in Validation Protocols and Reports Handling Deviations in Validation Protocols and Reports Validation in the pharmaceutical industry ensures that processes, systems, and equipment consistently produce products meeting their intended quality forms. A critical aspect of this validation lifecycle…