2 QLS Endorsed Courses | CPD Certified | Free PDF & Hard Copy QLS Certificates | 180 CPD Points | Lifetime Access
2 QLS Endorsed Course | CPD Certified | Free PDF + Hardcopy Certificates | 80 CPD Points | Lifetime Access
21CFR11 applies to records that are required to be submitted to the FDA, or that are subject to FDA inspection, and that are in electronic form – that is, as computer files. It applies to all computer systems used to create, modify, maintain, archive, retrieve, or transmit such records – from a humble spreadsheet program to a complex information management system.