Regulators also encourage you to adopt a lifecycle approach to validation. To stay ahead, life sciences companies of all sizes are turning to digitization to streamline the process validation lifecycle. The time- and cost-saving benefits of our fully automated process validation solution include:. Holistic validation management: The solution is tightly coupled with other ValGenesis solutions, including analytical method validation, cleaning validation, and equipment and instrument validation, for a holistic approach to validation management.
Risk-based approach: Using risk assessment models, our VLMS helps you conduct a risk assessment and mitigation plan for process design, parameters and attributes e. The risk assessment approach is also used to identify the number of batches to be taken as part of process performance qualification PPQ with required justification and approvals.
Increased data integrity: Our VLMS dynamically collects the critical control points CCPs , as per the predefined schedules, and updates batch records to eliminate human error and provide a higher degree of data integrity.
Process validation master plan: Our process validation master plan drives all stages of process validation and enforces the required studies and deliverables at every stage with required dependencies between studies and deliverables. With ValGenesis VLMS maintaining your organization's process validation efforts, you'll enjoy a host of robust features and functions, including:.
Avoid process disruptions in your manufacturing network with our risk-based, end-to-end solution. Dar respuesta a tu solicitud y hacer un seguimiento posterior. Ajustes de privacidad. Este sitio utiliza cookies funcionales y scripts externos para mejorar tu experiencia.
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Ver el perfil completo en LinkedIn. Boa noite Andreia. Gostaria de saber se fazer, qual valor?
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