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Overview
Particularly in areas with critical processes that rely on tight quality control such as the pharmaceuticals industry, regulatory guidance often requires records to be signed by an author, approver, tester, or other accountable individual.
While this signature process is historically associated with a hard-copy signature on paper, it has been extended in many areas to electronic records. For example, the United States Food and Drug Administration (FDA), in 21 CFR Part 11, describes how electronic signatures can be used to support automated processing.
The electronic signatures features of the Enhanced Controls module support this requirement. You can configure your system to require users of some programs to enter a valid user ID and password before they can create or update records. Additionally, they must provide a reason code that defines the meaning of the signature; for example, Approved or Tested. Based on setup data, users may be able to enter a related remark as part of the signature.
Note: Any valid user who has access to a program that records signatures can sign records. Use Menu Security (36.3.10) to assign access to signature-controlled functions based on user groups or individual user IDs. See Assign Access by Menu.
These features are intended as part of an overall approach—also incorporating capabilities offered by System Security and Audit Trails—to meeting the user accountability requirements of customers with regulated environments.