To review and approve a spec execution record:
When the Results Entry user enters results for a batch into the spec execution record and sends it for QA approval, a task is sent to the specified approver(s). Click the task link.
If the spec execution record was sent to a group for approval, click Accept to accept the task. Only one person needs to accept it.
In the Details section, click the Certificate of Analysis (CoA) link to open and view the document. The CoA summarizes the batch information and shows the testing results.
Check the Exception Summary to quickly find and focus your review on any results that were previously out of specification or had revisions during results entry. Click into any exception for more details.
Name Indicates Description Out of Specification Result does not meet Criteria with an indication of Out of Specification Previously Out of Specification Result was out of specification prior to being edited, and is no longer out of specification Out of Control Result does not meet Criteria with an indication of Alert Revised Result was changed after result evaluation Reopened Lab Test has been reopened Retested Lab Test has been retested Open the Release Limits and Control Limits sections. Review the Criteria, Evaluated Value, and check whether the result Conforms or is out of specification.
Open the Samples section. Hover over a sample name and select Launch Review window from the Actions menu.
Optionally, click the plus icon () to add additional samples. You can add up to 20 samples.
Optionally, drag and drop the samples in the order you want to display them in.
Click Continue.
If a Certificate of Testing was uploaded for the sample during results entry, click the document icon () to open the results for that sample.
Compare the entered results to the results provided by the testing lab to ensure accuracy.
Click an exception to only show the result(s) associated with the exception.
Hover over a result and select View Result Changes to see a full history of changes to this result.
Click Exit () to close the results window.
When your review is finished, click Complete.
Provide your verdict.
- Select Return for Edits if you anticipate approving the spec execution record but edits are needed first. Enter the Reason for return and click Complete. The spec execution record will be returned to the Results Entry user to make updates and, when ready, send for approval again.
- Select Reject Spec Execution if you will not move forward with approving the spec execution record. Enter the Reason for return, provide your e-signature, and click Complete.
- Select Approve to approve the spec execution record. Provide your e-signature, optionally add a CoA Comment that will display on the Certificate of Analysis, and click Complete. The spec execution record changes to Approved. The Certificate of Analysis changes to Final.
Certificate of Analysis (CoA)
For an Approved spec ex, the CoA will move to Final after the LIMS Change CoA State to Final job next runs. This job runs every hour.
To move a CoA to Final before the job runs:
Open the Certificate of Analysis.
Select Make CoA Final from the Workflow menu.
Click Yes to confirm.
If your LIMS Basics Vault is connected to a Quality Vault, the CoA will be sent to your Quality Vault through the connection.