Use case: batch records
Electronic Batch Records
You don't need an MES to have an electronic batch record. Docufen lets your operators complete the batch records you already use, digitally, with every entry attributed, timestamped and kept in the audit trail.
An eBR does not have to mean an MES
In most of the market, "eBR" means a module inside a manufacturing execution system. So when a site asks for electronic batch records, it is usually offered an MES project: months of configuration, every batch record rebuilt as screens, and a new way of working for operators to learn.
There is another way. Your batch records are already Word documents. Docufen keeps them as they are and lets your team complete them on a screen instead of on paper. The layout, the steps and the review flow QA approved stay the same. Only the pen changes.
How it works
Upload the batch record you use today, add the people who will complete it, and issue it. Operators then work through the document they already know, on a computer, tablet or phone.
Text entries
Operators type values, times and checks straight into the batch record, in the places they would have written them by hand. Each entry records who made it and when.
Photo evidence
A filter integrity test printout is photographed and attached to the step it proves. Two people then verify the attachment as a true copy of the original, inside the record.
Signatures
Checks and approvals are signed in the document itself, so the signed record and its audit trail stay together.
483s and data integrity
Batch record errors are a familiar source of inspection findings: missing entries, late entries, overwritten values and signatures nobody can trace. On paper, the only control is a reviewer who catches the problem afterwards.
In Docufen, each entry is attributed and timestamped the moment it is made, and a correction is recorded next to the original instead of replacing it. The record shows what happened, who did it and when.
Faster review and batch release
Reviewing a paper batch record means checking every page for gaps, unreadable entries and missing signatures before the batch can be released. Much of that checking is about the paper, not the batch.
When the record is completed digitally, entries are legible and attributed as they are made, so review can focus on the batch itself. This matters most when release time is critical.
Off paper without a big system
Many sites stay on paper because the only alternative on offer is a large system they cannot justify. Docufen starts with the documents you already have, so you can stop printing batch records now, and add a batch manufacturing system later if you ever want one.
Two types of eBR: MES-built and paper-like
Both approaches give you an electronic batch record. They differ in what has to change to get there.
| MES-built eBR | Paper-like eBR (Docufen) | |
|---|---|---|
| Approach | A module inside a manufacturing execution system | Your existing batch record documents, completed digitally |
| What changes | Batch records are rebuilt as screens inside the MES | Nothing: the same documents, procedures and rules as paper |
| Operators | Learn a new system | Complete the record they already know |
A full MES does a lot. But buying one does not guarantee a good batch record, and you do not need one to get a compliant one.
Cost and implementation
Docufen is priced per page, with no per-user licence fees, so everyone who works on the batch record can be added. There are no batch records to rebuild, which keeps implementation short.
Not just batch records
The same approach works for any GxP document your team completes on paper today.