When we wouldn't recommend Docufen
If you only need to sign and approve documents, Docufen isn't for you. A dedicated e-signature tool will be quicker and simpler.
But if you already complete documents in Docufen, with entries, signatures and attachments, you can sign and approve them there too. When your IQ, OQ and PQ are already in Docufen, your sign-only validation documents (URS, functional specs, risk assessments) can be signed there as well, so the whole validation package sits in one place. Already approving in an eQMS? Keep it there, and use Docufen for signatures inside your documents, like reviewing a table or a section.
How it works
- 1Drop in your Word document. No preparation.
- 2Add the people who need to sign, and turn on signing order if one goes first.
- 3Need to show someone where to sign? Highlight the cell, add a note and @mention them. Like a post-it on paper, it takes them straight there.
- 4They get an email, click the link, and the document opens, just like one left on their desk.
- 5They click in their table cell, choose a signing reason such as "Reviewed by" or "Approved by", and sign with their Microsoft username and password, plus MFA if your organisation uses it.
- 6With signing order on, the next person is notified automatically.
Problems because of paper
01
E-signatures used without validation
Many sites sign GxP documents with tools they've never validated, so each signature can't be reliably traced to a person. When you implement Docufen, signing is validated as part of validating the app, and every signer is traced through their Microsoft sign-in and your signature register. So you'll always know who signed.
02
Signatures overlapping document text
When a signature is placed in a drawn box on a static PDF, the signature block can grow, with its ID and details, and spill over the document text beneath it. Inspectors cite that as a non-compliance. In Docufen, you sign inside the table cell, and the cell grows with the signature, so nothing ever overlaps.
03
Paying for licences and mistakes
When licences are costly, only a handful of people can send documents for signing, so everyone else waits on them. And mistakes happen all the time: an envelope is routed for signatures, someone spots an error, and it has to be recreated, so you pay again for the new envelope. Docufen has no per-user fees, so anyone who needs to can send and sign, and you don't pay for mistakes.
Ask your vendor: how many people can send for signing on your plan, and do you pay again when an envelope is cancelled?
04
Hybrid documents: signed digitally, completed on paper
An e-signature captures one static moment. So you pre-approve digitally, print the document to fill it in, then scan it and post-approve it, leaving two records to maintain: the signed blank and the wet-ink copy. In Docufen, pre-approval, execution and post-approval happen in the same document, so your signatures follow it through its whole life cycle. If a correction is needed after signing, it's made in the cell, initialled and time-stamped, and the reviewer re-signs below it, so their signature covers the latest content.
Two types of e-signatures: Static vs Living (compared to digital systems)
Going digital doesn't have to mean a digital transformation.
| Static e-signatures | Living e-signatures (Docufen) | |
|---|---|---|
| Document format | Static PDF | Your original Word document, sealed |
| Preparation | Draw a box for every signature and entry | None |
| Entries and data | Not captured | Initialled and time-stamped |
| Corrections after signing | Cancel and send a new envelope | Correct in the cell and re-sign |
| Paper | Often printed to complete (hybrid) | Completed in one document |
| Best for | Sign-only approvals | Documents you complete and sign |
Cost and implementation
What it takes to go live, and what your cost grows with.
| Static e-signatures | Docufen | |
|---|---|---|
| Pricing | Per user licence or per envelope, depending on the tool | $0 per user (unlimited users). You pay per page completed. |
| Restarting a document when reviewers find an error | Ask your vendor | Not charged: cancel it and start again, as long as no data has been entered yet |
| Implementation | Ask your vendor | 5.7 working weeks, validated. See the case study |
Ask your vendor: how many people can send for signing on your plan, do you pay again when an envelope is cancelled, and how long does validation take?
Not just e-signatures
The same living signatures work across all your GxP documents, from execution to approval.