Electronic Signatures
How-to · Administrators (to enable) + result-entry and validation staff (to sign)
Purpose | Turn on electronic signatures and use them to sign result entry and validation, supporting 21 CFR Part 11–style accountability. |
|---|---|
You'll end up with | Result entry and validation that require the user's electronic signature, recorded in the audit trail. |
Who does this | An administrator enables it once; result-entry and validation staff then sign. Access is set by user permissions and can be configured by your administrator. |
Before you start | Decide that your laboratory requires electronic signatures; each signing user needs their own OpenELIS login. |
Where | Enable: Main menu → Admin → General Configurations → Site Information. Sign: in result entry and Main menu → Validation. |
Electronic signatures are off by default. An administrator turns them on with one Site Information property; after that, saving during result entry or validation requires the user to sign. The first time a user signs, they complete a one-time certification; afterward they confirm with their password.
Step 1 — Enable electronic signatures (administrator)
Open Main menu → Admin
Click General Configurations
Click Site Information.
Select the electronicSignatureEnabled property and click Modify.
Set Value to True and click Save.
Optionally, set esigSessionTimeoutMinutes (how long a signing session stays active before the password is required again; default 30).
Step 2 — Sign during result entry and validation
Once enabled, the signature is requested whenever a user saves in these workflows.
Enter or validate results as usual — in result entry, or in Main menu → Validation — and click Save.
The Electronic Signature Certification dialog opens. Read the statement, tick "I have read and understand the above statement," enter your OpenELIS password, and click Certify & Continue. (Certify & Continue stays disabled until both the box is ticked and a password is entered.)
The save completes and the signed action is recorded. The full certification is a one-time step per user; after it, saving simply asks the user to confirm with their password.
The Electronic Signature Certification dialog shown on save: the legal statement, the acknowledgment checkbox, and the password field.
Field reference
Field | Notes |
|---|---|
electronicSignatureEnabled | Site Information property. True turns on 21 CFR Part 11 electronic signatures for result entry and validation; default False. |
esigSessionTimeoutMinutes | Inactivity timeout for the signing session, in minutes (default 30). |
"I have read and understand the above statement" | Required acknowledgment on the certification dialog. |
Password | The signer's OpenELIS password, entered to confirm each signature. |
Notes
Certification is a one-time action per user; afterwards, signing proceeds directly to password confirmation.
Make sure everyone who will sign results has their own login and has completed certification before go-live.
Electronic signatures apply to result entry and validation; turning the property back to False removes the prompt.