The Electronic Batch Record Built From the
Approved Paper Master You Already Write

Mareana EBR converts your existing paper batch records into digital data-entry screens using AI-assisted conversion with human approval. Operators execute the same steps, in the same order, on screens that mirror the pages they already use.

Most EBR projects lose 12 to 18 months rebuilding the paper process as forms. Mareana skips it and starts from your approved paper record.

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Why Electronic Batch Record Implementations Take 12 to 18 Months

The delay is form design: rebuilding your approved process in a vendor's tool, then validating the copy. Mareana removes this step. Your paper master already covers it.

EBR Conversion workflow

Four steps and one gate. Nothing reaches the floor until a reviewer at your site approves it.

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Approved master batch record

What your team does, and what we do

You keep writing and approving records the way you do today. We handle the conversion.

Stays the same

You write and approve

Process owners write the master batch record. QA approves it. Same route, same authority.

Handled by Mareana

We convert it

Mareana turns the approved record into digital screens. This work does not land on your team.

One new step for you

You check the result

Your reviewers approve the converted screens before release.

Where AI Operates in a GxP Batch Record, and Where It Does Not

AI drafts the digital screens once, and a person approves them. During execution, every check is a fixed rule.

01Mareana AI

AI drafts your screens

It starts from your approved paper record. This happens once.

02Your reviewer

A person approves them

Nothing goes live without this approval.

03No AI

Every batch runs on fixed rules

Required fields, allowed ranges, step order and signatures. The same result every time.

A rule has no guesswork in it. It gives the same answer on batch one and batch one thousand.

Operator adoption, process change and the paper-on-glass question

Same steps, same order, same page. Training covers a new surface, not a new process.

Operators

Record batch data on the same page they already sign, on a tablet. Same layout, same order.

Master changes stay controlled

Operators never edit the master. Revisions follow your existing change control: update the paper master as you always have, re-feed it, and the screens update.

Paper on glass, on purpose

Data goes in on the tablet, not transcribed later. Paper generated during execution is scanned into the same batch record.

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EBRx checks your systems in real time

Before an operator can continue, EBRx asks your backend systems whether it is safe to proceed. If the answer is no, the step stops.

Equipment logs

Is the equipment in calibration, and free of open faults or work orders?

Cleaning records

Was it cleaned and verified since its last batch or product change?

Release status

Are the materials and lots you are about to use released for production?

Quality blocks

Is there an open deviation or hold that should stop this step?

Trace any batch, from the first one

Every batch you run with EBR feeds the batch genealogy graph automatically. No separate integration project.

Linked as you work

Materials are tied to batches as they are scanned and used.

Trace both ways

Follow a finished lot back to every input, or a suspect input forward to every affected batch.

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You have questions. We have answers

Most of the time goes to form design: rebuilding your approved process in a vendor's tool, then validating the copy. Mareana removes this step by starting from the approved paper master you already have.

Yes. You edit the paper master as you always have, re-feed the pages, and the screens update. Each revision goes through the same review before release.

Required fields, allowed ranges, step order and signatures. EBRx can also ask your backend systems about equipment logs, cleaning records, release status and quality blocks before an operator continues.

It looks like the page, on purpose, but data is entered straight on the tablet and checked by fixed rules as it is entered. Nothing is written on paper first and typed in later.

AI drafts the digital screens once, from your approved paper record, and a person approves them. During execution there is no AI: every batch runs on fixed rules.

Need More Information?

Connect with our experts to see how Mareana EBR turns your approved paper batch records into validated, look-alike digital screens.

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Bring one page.
We'll show you the rest.

Walk through the conversion with our team: an approved paper master in, a look-alike data-entry screen out, and the review step your QA owns in between.

A Few Details to Get Started

Share your details to book a quick demo and see Mareana EBR in action.

Lessons from the First FDA Warning Letter on AI Misuse
/ BEFORE YOU GO

Lessons from the First FDA Warning Letter on AI Misuse

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