Audit Trail Reviews of Electronic Health Records

Are You Managing Your Electronic Health Records Properly? According to the ECA Academy, MHRA inspectors have recently noticed several major findings during their inspections.  Issues have been noted with audit trails, access and security, scanning and certified...

Audit Trail Reviews of Electronic Health Records

Are You Managing Your Electronic Health Records Properly? According to the ECA Academy, MHRA inspectors have recently noticed several major findings during their inspections.  Issues have been noted with audit trails, access and security, scanning and certified...

Premarket Submissions for Non-Clinical Bench Performance Testing

Do you know the content and format requirements for submitting Premarket Submissions for Non-Clinical Bench Performance Testing? Recent FDA guidance describes the relevant information that should be included in test report summaries, test protocols and complete test...

Quality Requirements for Drug-Device Combinations

(From European Medicines Agency): Guidance is provided on dossier requirements for drug-device combinations (DDCs) in the context of a regulatory submission (marketing authorisation application and post-authorisation application). The types of DDCs within the scope of...

FDA: Initiation of Voluntary Recalls

From the Federal Register, Wednesday, April 24, 2019: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled ‘‘Initiation of Voluntary Recalls Under 21 CFR part 7, subpart C.’’ The draft...