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Este informe resumen de validación recopila datos suficientes y la calificación ejecutada relacionada con el sistema informático de QC_DOC, asegurando su validación exitosa para el sistema de monitoreo ambiental en un entorno farmacéutico.
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The validation summary report is used to summarize the results of validation activities, ensuring that the processes or systems meet specified requirements and are functioning as intended.
Individuals or organizations involved in regulated industries, such as pharmaceuticals or medical devices, are typically required to file validation summary reports. This includes manufacturers, quality assurance personnel, and project managers.
To fill out a validation summary report, one should gather data from the validation process, summarize the methodologies used, present the test results, and outline any deviations or issues encountered, followed by a conclusion about system compliance.
The purpose of the validation summary report is to provide documentation that demonstrates compliance with regulatory requirements, verify that processes are reliable, and serve as a communication tool among stakeholders.
The validation summary report must include information such as the scope of validation, methodologies used, results of tests conducted, any discrepancies or non-conformances identified, corrective actions taken, and a final assessment of compliance.
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