medical device validation – Pharma Validation

SOPs Required for Transport and Cold Chain Qualification

SOPs Required for Transport and Cold Chain Qualification SOPs Required for Transport and Cold Chain Qualification In the pharmaceutical and medical device industries, ensuring the integrity, quality, and compliance of products during transport and storage is paramount. This article outlines…

How to Document Packaging Justification in Regulatory Filings

How to Document Packaging Justification in Regulatory Filings How to Document Packaging Justification in Regulatory Filings In the highly regulated environment of the pharmaceutical industry, proper documentation of packaging justification is pivotal for ensuring compliance with various guidelines, including those…

How to Present HVAC Data to Inspectors: Do’s and Don’ts

How to Present HVAC Data to Inspectors: Do’s and Don’ts How to Present HVAC Data to Inspectors: Do’s and Don’ts The validation of HVAC systems is critical in maintaining an appropriate environment for manufacturing and storing pharmaceutical products and medical…

Who Owns Validation Documents? QA vs Validation Teams

Who Owns Validation Documents? QA vs Validation Teams Who Owns Validation Documents? QA vs Validation Teams Understanding the ownership and management of validation documents is critical in ensuring compliance within the pharmaceutical industry. This article provides a comprehensive, step-by-step validation…

Creating a VMP Dashboard to Monitor Quality System Integration

Creating a VMP Dashboard to Monitor Quality System Integration Creating a VMP Dashboard to Monitor Quality System Integration In the ever-evolving landscape of the pharmaceutical industry, monitoring the integration of quality systems across the lifecycle of medical device validation is…

Common Challenges in Multi-Site Equipment Qualification

Common Challenges in Multi-Site Equipment Qualification Common Challenges in Multi-Site Equipment Qualification In the pharmaceutical industry, the validation of medical devices is paramount to ensure compliance with regulatory requirements and to guarantee the safety and efficacy of products. Multi-site equipment…

Establishing Control Strategy as Part of Validation Lifecycle

Establishing Control Strategy as Part of Validation Lifecycle Establishing Control Strategy as Part of Validation Lifecycle In the fast-evolving pharmaceutical and medical device sectors, establishing a robust validation strategy is critical to ensure product quality, compliance, and patient safety. The…