Non-compliance with the FDA Regulations can lead to fines and cost millions of dollars, making the risk of ignoring these issues high.
The SAP ERP business applications include standard functionality that allows organizations to be FDA 21 compliant; this functionality requires a user to re-authenticate when they are signing and approving electronic records. To support the FDA requirements the SAP System contains standard support for electronic or digital signatures, which enables a user to sign and approve digital documents, but it makes the assumption that the user identifies themselves with a SAP user ID and password. The signature ensures that the person signing a digital document is uniquely identified and that the signatory’s name is documented along with the signed document, date and time.
There are many options available for authenticating users when they log on to SAP applications, either using standard SAP functionality, or using an add-on product, such as TrustBroker.
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