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.
Problems because of paper
01
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.
02
Slow 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. 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 time is critical.
03
Getting 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 end-to-end digital.
Three types: MES, eBR (paperless) and eBR paper-like (compared to digital systems)
Going digital doesn't have to mean a digital transformation.
| MES | eBR (paperless) | eBR paper-like (Docufen) | |
|---|---|---|---|
| Your documents | Rebuilt as screens inside the MES | Requires transforming your docx into eForms | Compatible with your existing docx |
| Approach | Batch record is a module inside a full manufacturing execution system | Paper batch records rebuilt as eForms | Your existing batch record documents, completed digitally |
| What changes | Batch records and wider manufacturing processes | Every record rebuilt as an eForm, then validated and maintained | Nothing: same documents, procedures and rules as paper |
| Operators | Learn a new system | Learn new eForms | Complete the record they already know |
| Adoption | Slowest: a large project | Slow: an eForm build for every record | Fast: start with the documents you have |
You can buy a full MES and still get a weak batch record. You do not need one to get a compliant one.
Cost and implementation
What it takes to go live, and what your cost grows with.
| MES | eBR (paperless) | eBR paper-like (Docufen) | |
|---|---|---|---|
| Implementation time | Months to 1+ year, depending on company size | Months | 5.7 working weeks, validated. See the case study |
| Licensing cost | Per user, per site or per line (varies by vendor) | Per user or per concurrent user | $0 per user (unlimited users). You pay per page completed. |
Ask your vendor what happens to your price when you add 20 more users.
Not just batch records
The same approach works for any GxP document your team completes on paper today.