Validation protocols, completed digitally
Think of a smoke study on paper. The video sits on a drive somewhere, its file name goes into a spreadsheet, and the reviewer has to find it, match it to the protocol step and trust it is the right one.
In Docufen, you drag the video onto the protocol step and it plays right next to the step it proves. No spreadsheet of file names, no repository access to arrange. The same goes for your IQ, OQ and PQ protocols.
How it works
Your protocols stay the Word documents you wrote and approved. The team executes them on screen, and everything they add is recorded in the document.
Smoke study video
Drag and drop the video onto the protocol step. It plays next to the step it proves.
Attachment and signature logs
Generated automatically, in real time, as the protocol is executed. No chasing people at the end to complete them.
Remote execution
Computer system validation can be executed without being on site.
Fast SCADA alarms
Alarms that a screenshot misses are screen-recorded and attached as video evidence.
Test evidence
Evidence is attached to its step and verified as a true copy of the original, inside the protocol.
Problems because of paper
01
Documenting in real time is a real challenge
Capturing all the evidence and compiling the document as you test is so slow and difficult that engineers write things up after the fact, issues get spotted late, and there's little time left for critical thinking.
02
One paper copy, chasing corrections
The protocol is a single paper copy moving round the site, so every error found at review means tracking down the right person, getting it fixed, and going back and forth until it's signed off.
03
Manual signature and attachment logs
Every signer has to be added to the signature log by hand, and you chase anyone who forgot. Every attachment page needs labelling and an attachment log. In Docufen, both are done for you, automatically and in real time.
Two types of digital validation: Paper-less Validation vs Paper-like Validation (compared to digital systems)
Going digital doesn't have to mean a digital transformation.
| Paper-less Validation (Digital Validation Tools / Validation Management Systems) | Paper-like Validation (Docufen) | |
|---|---|---|
| Approach | End-to-end digital validation tools | Your existing validation protocols, completed digitally |
| What changes | Protocols rebuilt inside the tool | Same Word protocols and procedures, no transformation |
A different type, not a cheaper copy.
Cost and implementation
What it takes to go live, and what your cost grows with.
| Paper-less Validation (Digital Validation Tools / Validation Management Systems) | Paper-like Validation (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. |
| External consultants and contractors | Ask your vendor: does each contractor need a licence? | Invite any vendor, contractor or consultant at no extra cost, with no IT request or budget approval |
| Training | Learn a new tool, including every external contractor | Minimal: the same Word documents and processes your company already uses |
Ask your vendor what happens to your price when you add 20 more users.
Ask your finance team or budget holder whether you have approval to buy a licence, and pay for training, every time a consultant or contractor joins. And ask how long that training takes before they can start.
Not just validation
The same approach works for the rest of your GxP documents, from manufacturing to the e-signature step before a protocol is executed.