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Announcement of changes to FRDA form, including the addition of new questions. FRDs are required to answer these questions and provide information on additional/corrected pages sent to IR-4 HQ. This update aims to improve tracking and communication using the Electronic QA Reporting System.
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eQA UpdateWebinar FRDA Form Change, Section 4 Tammy W. Barkalow RQAP-GLPAssistant Director, Quality Assurance
Electronic QA Reporting System • Announcement: • Changes made to the FRDA form: • Additional Questions have been added to the FRDA audit form • FRDs will need to answer the Question. • If no additional pages are attached, select NO, then finish with responses. • If yes, the date the pages were mailed to IR-4 HQ QA needs to be entered
Electronic QA Reporting System • Reason: • In order for a FRDA audit to be completed the SDs need to receive the additional/corrected pages from the FRDs and insert those pages into the FDB • The SDs at IR-4 HQ are having difficulty tracking when pages are coming to HQ and if they had been sent • Answering these questions provide information to the SDs so they know there are pages and that they have been sent to HQ
Electronic QA Reporting System • Follow up: • SDs, QA, Regional Field Coordinators and FRDs were asked for their input on how to best provide the needed information and at the same time make it as unobtrusive as possible. • We wish to thank all those who provided their input • If you have any questions please feel free to contact myself, Jane Forder, Juliet Thompson or your Regional QA personnel • Your assistance is greatly appreciated.
Thank You!