FAQ: "I am assisting Keith in completing the System Validation and are using the checklist found in the System Validation Checklist of the Validation and Compliance Notebook you provided. In step 40 and 41 the test user is to ensure that the e-Signature function is grayed out, but then step 45 has the Admin verify that a signature is in the audit log. Is this a typo with one of the steps? And if not, what is the reasoning behind not allowing users generating the data to sign it as the creator?"
This test sequence makes sense because e-Signature review of the Jobs of records is not the same as creation of the data record.
When a QCERAdmin or QCERUser logs into EasyMatch QC-ER, their steps outside of a Job are recorded in the Events log and inside a Job logged in the Audit log which is stored as part of the Job.
When a measurement (Standard, Sample or Series) is initiated, the creator of that record is the person logged into EasyMatch QC-ER at the time. This is stored with each data record in the Operator ID field that is part of the metadata stored with the spectral data for each record. Other non-editable, automatically stored metadata items are fields like a date/time stamp.
If you hover your mouse over the COLOR DATA TABLE view/Right Click/CONFIGURE you can add an Operator ID to the display for any Job at any time.
The Operator ID records the creator of the record from the login, and fixes it to the data record, recallable at any time.
e-Signature is intended as a review process of the Job after measurements have been taken. This role is specifically denied to QCERUsers (see SW IQ-24) which is verified in steps 40, 41. The eSignature review process is the privilege of QCERAdmins only which is affirmed in steps 45 – 48.
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