Computer Software Validation of Design of Experiments Software
Waghchaure Rajeshree Suresh · International Journal of Science and Research (IJSR) · 2025
Computer software validation plays a crucial role in ensuring the quality and reliability of pharmaceutical processes, particularly within the framework (QbD). In this context, Design of Experiments (DOE) software is an essential tool used to optimize formulations, processes, and manufacturing systems, ensuring that pharmaceutical products meet desired specifications. This review examines the critical aspects of computer software validation in the pharmaceutical industry, specifically focusing on DOE software used in QbD. It highlights the regulatory requirements, best practices, and methodologies involved in validating software tools, ensuring that they meet stringent standards for accuracy, reliability, and traceability. Additionally, the review discusses the challenges encountered during validation processes, including software documentation, risk assessments, and system integration, while emphasizing the need for continuous monitoring and revalidation in a constantly evolving regulatory landscape. By addressing the intersection of software validation, QbD principles, and DOE software applications, this review aims to provide a comprehensive understanding of how proper validation supports the design, development, and manufacturing of high-quality pharmaceutical products.