From URS to protocols. Traceable. Faster.
Import your URS once. VyScrip links each requirement to its IQ/OQ/PQ 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.
| 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.
Request early access
Be one of the first engineers to use VyScrip and help shape it.
- Early access to VyScrip
- Early-bird price of €89 per month, locked in for as long as you stay subscribed, for everyone who subscribes before 31 December 2026
- A short feedback form to tell us what works and what doesn't
Request early access
What's next for VyScrip
Planned
4- Use your own document template
- Audit trail: who changed what, when and why
- + 2 more on the roadmap
In progress
1- Installation checks, equipment identification and data integrity checks
Done
4- Import the URS from Word and Excel
- Impact review when a new URS revision comes in
- + 2 more on the roadmap
Questions engineers ask
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. Other VyScrip users cannot see your projects. When you click 'Generate suggestions' or 'Generate test steps', the text involved is sent to our AI provider (Anthropic) in the US. It is not used to train their models.
Is there an audit trail?
Not yet; it is on our roadmap. Today VyScrip records who imported and confirmed each requirement and when, who reviewed changes after a new URS revision, and the original URS text when a requirement is edited. Issued revisions are fixed. The signed paper protocol is 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 colleagues use my account?
No. A subscription is for one user, and logins should not be shared. Team accounts are on our roadmap.
What does it cost?
€89 per month for everyone who subscribes before 31 December 2026, locked in for as long as you stay subscribed. From 1 January 2027 the price is €129 per month. Prices exclude VAT. See pricing