Tag: computer system validation in pharmaceuticals

Cross-Referencing Audit Trails in Validation Reports

Cross-Referencing Audit Trails in Validation Reports Cross-Referencing Audit Trails in Validation Reports In the dynamic landscape of pharmaceuticals, data integrity is paramount. With regulatory bodies such as the FDA, EMA, and others underscoring the importance of adhering to Good Manufacturing…

Data Integrity Training for Validation and QA Teams

Data Integrity Training for Validation and QA Teams Data Integrity Training for Validation and QA Teams Data integrity is a cornerstone of quality assurance in the pharmaceutical industry. As organizations implement computer systems for compliance with Good Manufacturing Practices (GMP),…

Integration of VMP with CAPA, Change Control, and Deviations

Integration of VMP with CAPA, Change Control, and Deviations Integration of VMP with CAPA, Change Control, and Deviations Step 1: Understanding and Establishing the Validation Master Plan (VMP) The Validation Master Plan (VMP) serves as a crucial document that outlines…

Preparing a VMP Summary for Regulatory Submissions (e.g., NDA/MAA)

Preparing a VMP Summary for Regulatory Submissions (e.g., NDA/MAA) Preparing a VMP Summary for Regulatory Submissions (e.g., NDA/MAA) The preparation of a Validation Master Plan (VMP) Summary is a critical task for professionals in the pharmaceutical industry, specifically when preparing…

How Often Should a VMP Be Reviewed or Reapproved?

How Often Should a VMP Be Reviewed or Reapproved? How Often Should a VMP Be Reviewed or Reapproved? The Validation Master Plan (VMP) is a crucial document in the pharmaceutical industry, serving as a framework for ensuring compliance with regulatory…

GAMP 5 Guidance for Cloud-Based System Validation

GAMP 5 Guidance for Cloud-Based System Validation GAMP 5 Guidance for Cloud-Based System Validation In the context of pharmaceutical development, computer system validation plays a pivotal role in ensuring compliance with regulatory requirements, particularly in a cloud-based environment. As organizations…

Spreadsheet Change Control SOP Template

Spreadsheet Change Control SOP Template Spreadsheet Change Control SOP Template In today’s pharmaceutical environment, the efficacy of computer systems plays a critical role in maintaining compliance and ensuring product quality. This article outlines a comprehensive step-by-step approach to computer system…

How to Perform Version Control for Spreadsheets

How to Perform Version Control for Spreadsheets How to Perform Version Control for Spreadsheets In the pharmaceutical industry, computer system validation (CSV) is an essential process to ensure that computerized systems adhere to regulatory requirements and support the safe and…

Role of URS and FAT/SAT During Tech Transfers

Role of URS and FAT/SAT During Tech Transfers Role of URS and FAT/SAT During Tech Transfers The process validation lifecycle is critical in ensuring that pharmaceutical and medical device manufacturing adheres to regulatory standards and delivers safe, effective products. This…

Writing CAPA for Failed Equipment Qualification Activities

Writing CAPA for Failed Equipment Qualification Activities Writing CAPA for Failed Equipment Qualification Activities In the highly regulated pharmaceutical industry, compliance with regulatory requirements necessitates robust validation processes. Among these processes, computer system validation (CSV) is a critical aspect that…