FDA Q&A Document on Electronic Records: IT Services and Digital Health Technologies
The new article highlights special considerations for IT service providers, as well as the ones related to the use of digital health technologies.
The new article highlights special considerations for IT service providers, as well as the ones related to the use of digital health technologies.
The new article emphasizes specific focus areas the authority will pay attention to when evaluating compliance in the context of electronic record-keeping procedures.
The new article explains the approach to be followed in the context of retention and management of electronic records.
The article highlights the key points related to the use of electronic records based on the applicable legislation.
The final article of the cycle explains the specific metrics to be measured in the course of clinical studies in order to collect accurate and reliable information regarding the products in question.
The article highlights the key points related to specific types of clinical trials.
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