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◆ PDA journal of pharmaceutical science and technology2026-08-07

Training under the CSV Microscope: An In-Depth Look at the Impact of Training on ERP System Validation AKA Don't let Finance muddy the waters: Poster Presented at PDA Week 2026.

Prerana Kumar

原始摘要(英文原文)· Original abstract
Effective training is essential in the life sciences industry, to ensure product quality and safety by preventing contamination and errors, meeting regulatory requirements, reducing operational risks, and enhancing overall efficiency.Validation activities for Building, Planning and Logistics platforms like Enterprise Resource Planning (ERP) systems benefit from a careful planning effort to ensure that the approach is well-suited to the diverse users and functional groups accessing the application. As an ERP system includes quality critical and business critical functions, the dynamics of Enterprise-Level Computerized System Validation (CSV) testing must be adapted to address this duality - and training plays a key role.Clearly differentiating the quality critical features from the business-critical features, authoring both detailed and unscripted tests based on quality criticality, and ensuring that functional groups and the test execution team are well trained on the methods of testing can greatly impact the success of your effort and accelerate speed to market.
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Training under the CSV Microscope: An In-Depth Look at the Impact of Training on ERP System Validation AKA Don't let Finance muddy the waters: Poster Presented at PDA Week 2026. — 科研速览 Science Skim