Tag: validation in pharma industry

Executive Summaries in Validation Reports: What to Highlight

Executive Summaries in Validation Reports: What to Highlight Executive Summaries in Validation Reports: What to Highlight Validation in the pharma industry is a critical component of quality assurance that ensures compliance with regulatory standards while maintaining product efficacy and safety.…

Template for Cleaning Validation Summary Report

Template for Cleaning Validation Summary Report Template for Cleaning Validation Summary Report The validation of cleaning processes is an essential aspect of maintaining compliance within the pharmaceutical industry. Cleaning validation ensures that residues from previous products do not contaminate subsequent…

Who Owns the VMP? Governance Structure in Global Companies

Who Owns the VMP? Governance Structure in Global Companies Who Owns the VMP? Governance Structure in Global Companies The Validation Master Plan (VMP) is a critical framework that defines the validation strategy and its execution within pharmaceutical organizations. Governance structures…

Audit Trail and Version History for VMP Updates

Audit Trail and Version History for VMP Updates Audit Trail and Version History for VMP Updates The pharmaceutical industry is governed by stringent regulations and guidelines that ensure safety, quality, and efficacy in product development and manufacturing. As part of…

Managing Delays and Deviations in VMP Execution

Managing Delays and Deviations in VMP Execution Managing Delays and Deviations in VMP Execution The validation in pharma industry is a critical component in ensuring product quality, safety, and efficacy. Delays and deviations are common challenges faced during the execution…

Part 11 Validation for LIMS, SCADA, and MES Systems

Part 11 Validation for LIMS, SCADA, and MES Systems Part 11 Validation for LIMS, SCADA, and MES Systems In the pharmaceutical industry, ensuring compliance with regulations and maintaining data integrity is paramount. The validation process for computer systems such as…

Real-Life FDA 483s Related to Part 11 Non-Compliance

Real-Life FDA 483s Related to Part 11 Non-Compliance Real-Life FDA 483s Related to Part 11 Non-Compliance 1. Understanding User Requirements Specification (URS) & Risk Assessment Validation in the pharmaceutical industry begins with a clear understanding of user requirements, followed by…

Understanding Audit Trail Review Frequency and Retention

Understanding Audit Trail Review Frequency and Retention Understanding Audit Trail Review Frequency and Retention In the realm of pharmaceutical validation, maintaining the integrity of data generated by automated systems is paramount. This article focuses on the critical aspect of audit…

When to Replace vs Requalify Legacy Systems

When to Replace vs Requalify Legacy Systems When to Replace vs Requalify Legacy Systems In the highly regulated environment of the pharmaceutical industry, ensuring compliance while maintaining operational efficiency is a paramount concern for numerous organizations. Legacy systems, which may…

Equipment Lifecycle Management: Adding Legacy Equipment

Equipment Lifecycle Management: Adding Legacy Equipment Equipment Lifecycle Management: Adding Legacy Equipment Step 1: User Requirement Specification (URS) & Risk Assessment In the pharmaceutical industry, developing a User Requirement Specification (URS) is the foundational step for successful validation activities. The…