Legacy Equipment Qualification

Handling Non-Compliant Legacy Equipment: Mitigation Plans

Handling Non-Compliant Legacy Equipment: Mitigation Plans Handling Non-Compliant Legacy Equipment: Mitigation Plans Step 1: Understanding User Requirements Specification (URS) & Risk Assessment The initial stage in the pharmaceutical validation lifecycle involves developing a User Requirements Specification (URS) and conducting a…

How to Define Criticality for Legacy Equipment

How to Define Criticality for Legacy Equipment How to Define Criticality for Legacy Equipment In today’s highly regulated pharmaceutical landscape, defining the criticality of legacy equipment is essential for maintaining compliance with FDA, EMA, and other regulatory requirements. This tutorial…

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…

Linking Legacy Equipment to Current SOPs and Workflows

Linking Legacy Equipment to Current SOPs and Workflows Linking Legacy Equipment to Current SOPs and Workflows In the evolving landscape of pharmaceutical manufacturing, maintaining compliance while utilizing legacy equipment presents unique challenges. This article serves as a practical guide for…

Legacy Equipment Risk Matrix Template (Downloadable)

Legacy Equipment Risk Matrix Template (Downloadable) Legacy Equipment Risk Matrix Template (Downloadable) In the context of the pharmaceutical validation lifecycle, ensuring the integrity and compliance of legacy equipment is vital for maintaining product quality and regulatory approval. This article provides…

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…