Tag: csv computer system validation

Using Data Logger Alerts to Trigger CAPA or Investigation

Using Data Logger Alerts to Trigger CAPA or Investigation Using Data Logger Alerts to Trigger CAPA or Investigation Step 1: Understanding User Requirements Specification (URS) and Risk Assessment The foundation of any robust validation lifecycle begins with a clear understanding…

Data Integrity in Batch Coding and Label Printing Systems

Data Integrity in Batch Coding and Label Printing Systems Data Integrity in Batch Coding and Label Printing Systems In the pharmaceutical industry, ensuring the integrity of data across various systems is crucial, especially within batch coding and label printing systems.…

Case Study: HVAC Failure Detected via Microbial Spike

Case Study: HVAC Failure Detected via Microbial Spike Case Study: HVAC Failure Detected via Microbial Spike This article details a progressive step-by-step tutorial on the validation lifecycle concerning a case study of HVAC failure detected via microbial spike. The primary…

How to Prepare Cross-Reference Tables in Validation Reports

How to Prepare Cross-Reference Tables in Validation Reports How to Prepare Cross-Reference Tables in Validation Reports The validation lifecycle in the pharmaceutical and biologics sector is a meticulously structured process that ensures compliance with regulatory frameworks such as FDA and…

CMO Audit Questions Around VMP Scope and Ownership

CMO Audit Questions Around VMP Scope and Ownership CMO Audit Questions Around VMP Scope and Ownership Step 1: Understand the Validation Master Plan (VMP) Scope The Validation Master Plan (VMP) is a critical document that outlines the validation strategy for…

How to Validate Systems That Store GMP Data

How to Validate Systems That Store GMP Data How to Validate Systems That Store GMP Data Step 1: Understanding User Requirements Specification (URS) and Risk Assessment The first step in the validation lifecycle for computer systems that will store GMP…

Validation of Utility Alarm Systems and Interlocks

Validation of Utility Alarm Systems and Interlocks Validation of Utility Alarm Systems and Interlocks This article provides a structured, step-by-step approach to validating utility alarm systems and interlocks within the pharmaceutical industry, emphasizing the necessary compliance with regulatory standards, including…

Handling Process Variability Identified in CPV

Handling Process Variability Identified in CPV Handling Process Variability Identified in CPV Step 1: Understanding the Role of Continued Process Verification (CPV) Continued Process Verification (CPV) is an essential aspect of process validation, ensuring that a manufacturing process remains in…