Data integrity, electronic approval and snapshots of approved data are critical to regulatory compliance. EAM has long provided capabilities that allow companies to comply with 21CFR11 guidelines. These capabilities include electronic signature (eSignature) and electronic record snapshots (eRecords). eSignature (i.e., electronic signature) is used in EAM to authenticate and capture the unique ID of the user vouching for the data on a record in the system. An eSignature has traditionally been triggered by a status change on the record. In addition, a ‘snapshot’ of the record is taken and stored. This snapshot stores a copy of the record as it existed at eSignature time. This often includes the data on the tabs of the screen as well.
Module features
Module feature |
Description of feature |
eRecords setup |
On the setup screen you specify which entities require eRecords and at which status changes the system should create these eRecords. Optionally you can also specify whether an eSignature is required at the time of the status change. Once defined on this setup screen the relevant screen covering the actual entity (work order screen for the work order entity, purchase order screen for the purchase order entity, etc.) will automatically perform the desired action when the relevant status change is applied on that screen. The lists of entities that support eRecords and eSignature is too long to list here includes but is not limited to:
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Work orders |
On the work order screen, you can also manually initiate an eRecord and an associated eSignature by manually clicking the eSignature icon. Changes to the work order data after an eRecord is created for that work order typically clears the signature data, meaning a new signature may be required. |
Other eSignature screens |
Several other screens within the EAM application offer eRecords and eSignature functionality. These include the permit to work screen and the calibration and checklist tabs of the work order screen. |
eRecords |
All screens that support eRecords and eSignatures also have an eRecords tab where all eRecords can be viewed and selected for reporting. |