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NOTE: ET SDP stands for Examinations, Treatments, Substances, Devices and Procedures, see Oregon Administrative Rule 811-015-0070. The ONCE evaluates ETS DPs to determine if they are standard, investigational
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What is etsdp device amp procedure?
The ESDP Device AMP (Electronic System for Deviation Procedure) is a method used to track, report, and resolve deviations in electronic systems.
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Any organization that uses electronic systems and encounters deviations is required to file the ESDP Device AMP procedure.
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The ESDP Device AMP procedure should be filled out electronically using the designated online platform provided by the regulatory authorities.
What is the purpose of etsdp device amp procedure?
The purpose of the ESDP Device AMP procedure is to ensure timely reporting and resolution of deviations in electronic systems to maintain compliance with regulations.
What information must be reported on etsdp device amp procedure?
Information such as the date of deviation, impact on electronic systems, root cause analysis, corrective actions taken, and preventive measures implemented must be reported on the ESDP Device AMP procedure.
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