When we wouldn't recommend Docufen
If you only need to sign SOPs, with no execution, attachments or lengthy Word forms to fill in, we don't recommend Docufen. A dedicated 21 CFR Part 11 compliant e-signature tool suits you better.
If you already use Docufen for documents you execute and fill in, you can approve your SOPs with Part 11 signatures in Docufen too.
How it works
- 1Upload your Word SOP (drag and drop).
- 2Add the approvers.
- 3They sign with 21 CFR Part 11 compliant signatures.
- 4Finalise the PDF.
- 5Put the Docufen link in your document register, so your register keeps track of where each approved SOP lives.
Problems because of paper
"Failure to follow written procedures" is one of the most cited FDA 483 findings, and hard-to-find, out-of-date paper copies are a big reason why.
01
Finding the SOP
On paper, people walk to a room, find the binder and grab the SOP, or use a satellite copy that may be out of date. With Docufen, every approved SOP has a unique URL that your document register links to. If you like, turn that link into a QR code and post it where the satellite copy used to be; when the SOP is revised, replace the QR code.
02
Finding the information inside the SOP
On paper, once you have the SOP you read through it to find the part you need; you can't search paper. In Docufen the text is searchable, so people search straight to the section they need and read only that.
03
Getting to the SOP from other documents
Forms, batch records and other documents usually just say "see SOP-123", with no fast way to get there. In Docufen you can put a link to the SOP right in the document, so people open it straight from the step where they need it, then search to the section.
Two types of digital SOPs (compared to digital systems)
Going digital doesn't have to mean a digital transformation.
If you already have an eQMS, keep your SOPs there. Docufen is for sites that don't have one yet.
| System-managed SOPs (eQMS / Document Management Systems) | Manually managed SOPs (Manual QMS + Docufen) | |
|---|---|---|
| Best for | Sites that already have an eQMS | Sites without an eQMS yet (manual register, e.g. a spreadsheet) |
| Format | Word documents, published as watermarked PDFs | Your existing Word SOPs, completed digitally as PDFs |
| Version control | Built in, with links to change control, training and CAPA | Stays your job, in your own register, following your internal procedures |
| Approvals | Workflow approvals with e-signatures | 21 CFR Part 11 compliant signatures |
| Getting to the SOP | Controlled printouts, tracked and recallable | A unique URL per SOP: link it in your register and documents, or turn it into a QR code |
| As you grow | Already there | Move your SOPs into an eQMS when you get one |
Ask your eQMS vendor whether each SOP can have a link or QR code that always opens the latest version. It could save you printing satellite copies.
Cost and implementation
What it takes to go live, and what your cost grows with.
| System-managed SOPs (eQMS / Document Management Systems) | Manually managed SOPs (Manual QMS + Docufen) | |
|---|---|---|
| Implementation time | Months | 5.7 working weeks, validated. See the case study |
| Licensing cost | Per user (varies by vendor) | $0 per user (unlimited users). You pay per page completed. |
Ask your eQMS vendor whether everyone on site needs a paid user login just to read the SOPs.
Not just SOPs
The same approach works for other GxP documents.