A Framework for Spreadsheet Validation
With the release of the Computer Software Assurance for Production and Quality System Software by the FDA, we get a clear framework to apply for spreadsheet validation.
Assessment
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Overview of Periodical Review of Equipment in GMP Environments.
In the dynamic field of Good Manufacturing Practices (GMP), ensuring the integrity, efficiency, and compliance of equipment is a requirement. This article looks into the essential aspects of periodical equipment reviews within GMP environments, highlighting their significance, processes, and outcomes. The Necessity of Periodical Equipment Reviews Regular reviews are crucial for maintaining equipment functionality and…
Enhancing Efficiency in GMP Equipment Validation Through Risk-Based Approaches
In the pharmaceutical industry, Good Manufacturing Practices (GMP) are fundamental to ensuring that products meet the highest standards of quality, safety, and efficacy. A critical component of GMP compliance is validation, which proves that equipment and processes consistently produce results as intended. Traditionally, validation is a resource-intensive process, often applying uniform rigor across all equipment…