From URS to protocols. Traceable. Faster.
Import your URS. VyScrip helps you link each requirement to its test steps and, if you need it, its risk assessment, and keeps the traceability matrix up to date, even when the URS changes. Export to Word, then print, execute and sign.
Join early access for 40% off: €89 a month for one user, €419 for a team of up to 5. See pricing
| Requirement ID | Requirement |
|---|---|
| URS-001 | The autoclave shall reach 121 °C within 30 minutes. |
| URS-002 | The chamber pressure shall be displayed in bar. |
| URS-003 | The door shall stay locked while the chamber is pressurised. |
| URS-004 | A cycle report shall be printed after each cycle. |
Less copying, more validation
One connected flow, from URS to Word export
Import your URS
Upload the Word or Excel file. Requirement IDs and text are taken over as written in the URS, so VyScrip matches your source document.
Assess the risks, if you need to
Risk assessment per requirement is optional. When your approach calls for it, score severity and probability and record risk controls. Click Generate suggestions for a first draft; every suggestion is labelled AI and you accept each one yourself.
- Risk
- Door opens while the chamber is pressurised
- Severity
- High
- Probability
- Low
- Risk control
- Design feature: door interlock
Write the IQ, OQ and PQ test steps
Write them yourself, or click Generate test steps for AI suggestions that you accept, edit or reject. Each test step is linked to the requirement it verifies.
- Test instruction
- Start a cycle and try to open the door during sterilisation.
- Expected result
- The door stays locked.
Check the traceability matrix
The matrix is built from the links you made. When a new URS revision comes in, VyScrip shows what changed and which risks and test steps you need to review. Export the matrix to Word to print it.
| Requirement | Risk control | Test step |
|---|---|---|
| URS-001 | N/A | OQ-001 |
| URS-002 | N/A | IQ-002 |
| URS-003 | Door interlock | OQ-003 |
| URS-004 | N/A | PQ-001 |
Export to Word
Issue each protocol with a document number and revision. Then print, execute and sign it on paper.
Operational Qualification
| Document number | AC200-OQ |
| Revision | 0 |
| Status | Issued |
Built by a validation consultant who is hired to do this work.
Writing qualification protocols takes a lot of time. VyScrip takes over the copying and linking, so you can spend your time on the validation itself.
Join early access
Be one of the first engineers and teams to use VyScrip and help shape it.
- Early access to VyScrip
- Early-bird price of €89 per month for one user or €419 for a team, locked in for as long as you stay subscribed, for everyone who joins early access before launch and subscribes within 1 month after launch
- A short feedback form to tell us what works and what doesn't
Join early access
What's next for VyScrip
Planned
2- One protocol set for identical equipment
- Modules for specific equipment: temperature mapping, sterilisers, water systems and instruments
In progress
2- Use your own document template
- Team accounts
Done
6- Audit trail: who changed what and when, with a reason for each new revision
- Installation checks, equipment identification and data integrity checks
- + 4 more on the roadmap
Questions engineers ask
Does VyScrip fit our procedures?
VyScrip works inside your quality system, not instead of it. Your URS is imported as written, with your own requirement IDs. You approve, execute and sign the protocols on paper, and handle deviations and changes in your own system. Using your own document template is in progress.
Do I need to validate VyScrip?
That is your decision, based on your own risk assessment and procedures. VyScrip is a documentation support tool. It does not approve, sign or execute GxP records: qualified personnel review the generated content, and the signed paper protocol is the record.
Does VyScrip use electronic signatures?
No. You export the protocols to Word, then print, execute and sign them on paper.
Does AI write my documents?
Only when you ask for it, with 'Generate suggestions' or 'Generate test steps'. Every suggestion is labelled AI, and you accept, edit or reject each one yourself.
Is my data safe?
Your data is stored in the EU (Ireland), encrypted at rest and in transit, and backed up daily. Only you, or the people in your team, can see your projects. When you click 'Generate suggestions' or 'Generate test steps', the text involved is sent to our AI provider in the US. It is not used to train their models.
Is there an audit trail?
Yes. VyScrip automatically records changes to your project content: who changed what, the old and new value, and when. When you start a new revision of a document, you enter the reason for change. The audit trail can't be edited or deleted, and you can export it to CSV. The signed paper protocol remains the record.
Which files can I import?
Word (.docx) and Excel (.xlsx). Requirement IDs and text are taken over as written in your URS.
What happens when the URS changes?
Import the new revision. VyScrip shows which risks and test steps you need to review. You mark each one as still valid or needing an update. You cannot issue a document while reviews in it are still open.
Can my team use VyScrip?
Yes. The team plan is for up to 5 people, each with their own login, working in the same projects. The one-user plan is for one person. Logins should not be shared.