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Hello, we are going to go through the process of uploading a new batch record for AI assisted batch review. So first, you will select the document that you want reviewed. After this, you will select the metadata for the documentation; the metadata is what associates the custom rules to each batch record.
So we are using the Medicore metadata to associate our rules with this batch record. So after the metadata has been applied, we will be putting in that “it’s a new batch to be reviewed” and we will let the system go through the extraction process and put in the rules for the process.
Now that the extraction has been completed, we are ready for post-execution.
So, the first step will be to associate all of the requirements with who is signing off on it and seeing who will be doing the final QA approval of the document.
I will not be putting in the supporting document for the weight slip that we used in this batch record
Any form of supporting document can be attached to these batch records.
So all of our green squares are system verified passes and all of our red squares are system verified fails.
So we have here missing information, so I will leave a note to the operators to put in the correct information and I will start my manual review.
I’m putting in passes for everything that passes that wasn’t an AI assisted rule. All the blue ones, as I mentioned, are AI assisted rules and new custom rules are being built in every day for more system verified passes.
So these are verifying things like GMP um calculations stuff of that variety. So I’m just going through manually approving the documentation as I see fit and the system is alerting me for anything that could be a miss. As there’s nothing being alerted, I’m just going through the document
If there’s any comments that need to be added, comments can be added during this section as well. Here there’s a minor alert that there is some documentation of slight deviation. I review the comment, see that it’s acceptable, I continue through the process and start to pass through everything.
Here, I’m reviewing the weight slip; this is the document that I attached during my supporting documentation phase and these supporting documents can be pictures of weight slips, PDFs of weight slips or any other form of document that you’d want to attach to your batch record. So I’m going to continue to go through the document. Each of these pages have been meeting my criteria as well as the system verified sections have been verified already.
There’s only a couple pages left and process is relatively easy. You’re able to quickly see if there’s anything wrong with the batch record and if there’s not. You’re just routinely going through the document making sure that everything else looks good. Anything else would show up as fail which would further cause review.
This section is a calculation based off our weight slips that we saw previously and the system is able to verify that the weights are added up and you’re able to do the reconciliation correctly. If the math was done incorrectly, the system would have alerted us with the fail.
So now the document is approved, we’re going to have operations put in a new document, so we’ll go through that process right now.
I’m going to upload a new document with all of the old metadata that was on the document but it would be compiled with the updated document. So everything that was already a system verified pass will stay and everything else that I’ve manually approved will stay. The only thing that will be new is the new operator information.
So now here I will go in to this new thing, as you can see all of my stuff is already complete. Now all I have to do is verify that the new information is correct. The system is telling me it’s correct so I’m should it put it down as a pass and put everything down as a pass. So now that my document is complete I can send it for QA approval.
So as QA approval needs a new person, a different person is signing off on this, so I’m able to sign off on this; you could set up the roles or accesses as you see fit. So it’s a completed document and it automatically sends all the information into the genealogy.
/ Any questions? We'd love to help
Mareana has helped numerous firms in the Pharmaceutical, Chemical, Medical Device, and Industrial Manufacturing industries.
Mareana provides AI for Batch Review in the form of AI Assisted batch Release to automatically extract, verify, and validate batch record data before Quality Assurance (QA) approval. It checks calculations, flags missing information, validates GMP-critical rules, and highlights deviations in real time.
AI Assisted batch review works by combining automated rule-based verification with manual quality oversight.
Here’s how the process typically works:
Upload the batch record
Apply metadata to trigger custom compliance rules
AI extracts and validates data automatically
System flags deviations (red) and verified passes (green)
QA manually reviews only flagged or non-AI items
Final approval is routed digitally
Data is stored in a complete batch genealogy
Mareana’s AI platform automate batch release process by eliminating repetitive manual verification steps and validating compliance before QA approval.
They automate:
Calculation checks
Data reconciliation
Metadata-based rule enforcement
Deviation detection
Supporting document validation
Digital sign-offs and routing
AI Assisted batch review helps improve batch release workflows by standardizing review criteria across all records.
It improves workflows by:
Associating metadata with custom compliance rules
Providing real-time red-flag alerts
Maintaining automated audit trails
Preserving manual approvals during re-processing
Streamlining operations-to-QA handoffs
AI Assisted batch release support multiple document formats, including:
PDF files
Weight slips
Images
Scanned batch records
Supporting compliance documents
Mareana’s AI powered platform strengthens GMP compliance by:
Enforcing predefined rule sets
Validating required signatures
Verifying calculations
Tracking deviations
Preserving audit trails
Maintaining digital genealogy records
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