eSignatures

OpenSystems, such as OpenMETRIC, support the use of eSignatures (Electronic Signatures).  These features and capabilities comply fully with 21 CFR Part 11.

To record an eSignature, a user must be defined as an eSigner, and assigned a password.    The user enters a name/password, chooses a type of eSignature for which he is authorized, and optionally enters comments.  The system validates his name and password, and then records the signature.

All eSignature records are kept in a log for future viewing.  The OpenSystems function, and often the key of the record being edited, is part of the eSignature log.

For additional information, select one from the subjects below:

Defining eSigners

Requiring eSignatures for OpenMETRIC Gate Functions

Add’l eSig Button

Viewing eSignatures

Defining eSigners

Click the button titled “Update Signers” on the Gate tab to add/edit eSigners.  A window appears where you can view/edit eSigners.

To add an eSigner, click New|Clear.  Enter a Name of the eSigner, a more descriptive name field if desired, a password, and an expiration date.  Click Add Type to choose from a list of eSignature types.   An eSigner can be authorized for multiple eSignature types.  Click New|Add to save your new eSigner record.

eSignature types are defined in the Reference file.

Requiring eSignatures for OpenMETRIC Gate Functions

To require an eSignature for a gate function, fetch the function on the Gate tab.  Click the Add Type button to select an eSignature type.  If multiple eSignature types are included, the eSignature requirement can be satisified by an eSignature of any of the specified types.

In the depiction below, an eSignatue of type “ADMIN” is required in order for a user to add or update an Item on the Item tab.

Once you’ve specified that an eSignature is required for a function, the eSignature screen appears whenever a user tries to access that function.

Add’l eSig Button

The Add’l eSig button appears on all screens that support eSignatures.  It provides a registered eSigner with a way to record an Electronic Signature at any time, for any reason. 

When the Add’l eSig button is clicked, the Electronic Signature screen appears. 

Viewing eSignatures

Click the eSig button on a tab to view previously entered eSignatures for that tab.   eSignatures may be record specific.

In the example below, the user has fetched Item 01 on the Item tab, and then clicked on the eSig button.  The list shows all eSignatures previously entered for that item.