Use case: validation
Digital Validation
Complete your validation protocols digitally, in the Word documents you already use. Evidence sits next to the step it proves, the logs build themselves, and every entry is attributable from the start.
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.
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.
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.
Data integrity by design
Every entry in the protocol is attributable, legible and contemporaneous, recorded with the time it was made. Reviewers check the validation, not whether the paperwork was filled in properly.
That gives your team time back: less administration, more time on quality review.
Two types of digital validation
Validation management systems and paper-like validation both take validation off paper. They differ in what has to change to get there.
| Validation management systems | Paper-like validation (Docufen) | |
|---|---|---|
| Approach | End-to-end digital validation tools | Your existing validation protocols, completed digitally |
| What changes | Protocols are rebuilt inside the tool | Nothing: the same Word protocols and procedures |
| Who can take part | Licensed users of the tool | Anyone you add, including vendors and contractors |
A different type, not a cheaper copy. Validation management systems suit teams that want their whole validation lifecycle in one tool. Docufen suits teams whose protocols already work and who want to stop printing them.
Cost and implementation
Docufen is priced per page, with no per-user licence fees. There are no protocols to rebuild, which keeps implementation short.
Because there is no seat to buy, you can add any vendor, contractor or consultant to a protocol at no extra cost, with no IT request or budget approval.
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.