• Instead of navigating to the task page, you can right-click the task in the My Tasks table and select Enter Review Details. • The Subject column in the My Tasks table lists the customer experience identification information. |
To see information relevant to the customer experience, including its affected objects and previous workflows, click the Structure link in the upper right corner of the window. |
Field | Description |
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Confirmed | Required. Select Yes or No to indicate if the customer experience was confirmed. |
Verified | Required. Select Yes or No to indicate if the customer experience was verified. |
Device Related | Required. Select Yes or No to indicate if the customer experience is related to a product or device. |
Initiate CAPA | Required. Select Yes to indicate that a CAPA has been or needs to be initiated. This question itself does not create a new CAPA. If Windchill CAPA is installed, a CAPA Change Requests table appears on the lower part of the page. To create new CAPAs based on this customer experience, click the new CAPA request icon in the CAPA Change Requests table. |
Correction Indicated | Required. Select Yes or No to indicate if there is a correction for the customer experience. The FDA’s Code of Federal Regulations Title 21 Part 806 defines a correction as “the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device without its physical removal from its point of use to some other location.” For more information, see the FDA’s website for 21 CFR Part 806. If you select No, enter information in the Correction Rationale field. |
Correction Rationale | If you select No from the Correction Indicated list, describe the rationale in this field. |