Paperless validation for GMP manufacturing.
Ravngard takes you from system inventory and risk assessment to executed protocols, e-signatures and periodic review — in one place, built for EU GMP Annex 11 and 21 CFR Part 11.
No sales call needed · sign in with your work email · sample data from a pharma plant
From the plant floor to the audit trail
Bioreactors, isolators, autoclaves, DCS and MES, LIMS and chromatography data systems: everything on the line needs a validated state and the evidence to prove it. Ravngard keeps that evidence complete, signed and findable — for every system, every change, every review.
See the product, not a brochure
Real screens from the live demo. Everything you see here you can try yourself in two minutes.
Functional risk assessment
Score severity, probability and detectability per requirement. Ravngard calculates the risk priority and the test depth it needs — with the GAMP 5 method on screen, not in a separate SOP.
- Linked to user requirements
- Risk priority drives test depth
- Approved with e-signatures, like every deliverable
Execute protocols on screen or tablet
Testers see one step at a time: the action, the expected result and a box for what actually happened. Pass, fail, evidence and deviations are recorded as they happen.
- Typed results and attachments per step
- A failed step opens a deviation automatically
- Executed protocol printed with signatures
See exactly what changed before you sign
Approvers compare any two versions of a document: text, requirements, tests and even the approval route. A differences report can be exported for the change record.
- Word-level differences
- Flags changed approval routes
- Frozen versions at every submit, approve and revise
A tamper-evident audit trail
Who did what, when and why, for every record. Entries are append-only and hash-chained, so any edit to history is detected.
- Reason for change captured
- Filter and export for audit-trail review
- Covers signatures, changes and deviations
Live traceability matrix
Requirement → risk → test → result, always current. Gaps are shown before the inspector finds them.
- Built from the records, not typed by hand
- Coverage and open items at a glance
- Exports to Excel for your report
Validation status across sites
Lifecycle state per discipline, periodic reviews due, cycle times and deviations by root cause — every figure calculated from the records.
- Overdue reviews and deliverables
- Filter by site and discipline
- Click any figure to see the systems behind it
One lifecycle, start to finish
Every system starts with an approved inventory record. Everything after it builds on that record, so nothing is forgotten.
Six disciplines, one tool
Validation is more than computerised systems. Ravngard covers the whole qualification and validation programme of a GMP site.
Computerised systems
DCS, MES, LIMS, CDS, historians, ERP.
- Inventory and GAMP 5 categories
- URS, functional risk, IQ/OQ/PQ
- Periodic review and data-integrity checks
Equipment
Autoclaves, filling machines, lyophilisers, washers.
- DQ, IQ, OQ, PQ
- Calibration-critical instruments
- Requalification schedules
Facilities & utilities
Grade A–D areas, HVAC, WFI and purified water, clean steam.
- Classification and qualification
- Environmental monitoring tests
- Deviation handling during runs
Processes
PPQ and continued process verification.
- CPPs and CQAs from the risk
- Batch-based protocols
- Statistical results recorded per batch
Cleaning
Product changeover and shared equipment.
- HBEL / PDE-based limits (MACO)
- Worst-case product selection
- Swab and rinse results
Analytical methods
Method validation and transfer.
- Specificity, accuracy, precision, linearity
- Acceptance criteria per parameter
- Transfer and verification protocols
Ravngard vs paper and Excel
Most sites still validate with Word templates, Excel trackers and wet-ink signatures. Here is what changes.
| — | Paper / Word / Excel | Ravngard |
|---|---|---|
| Versions | File names like URS_v3_final_FINAL.docx | ✓Frozen versions with side-by-side compare |
| Signatures | Printed, signed, scanned, filed | ✓Part 11-style e-signatures with meaning, linked to the version |
| Audit trail | None, or a manual change log | ✓Automatic, append-only, hash-chained |
| Traceability | A matrix typed by hand, often out of date | ✓Calculated live from requirements, risks and tests |
| Test execution | Handwritten results, transcription errors | ✓Results typed at the step, deviations opened automatically |
| Periodic review | Reminders in someone's calendar | ✓Due dates from the risk, overdue reviews on the dashboard |
| Inspection | Days to collect evidence | ✓Every record found in seconds |
Built by a validation engineer. Tested like a GxP system.
We are a young company, so we can't show you a wall of customer logos yet. Here is what we can show you.
“I spent years validating DCS, MES and historian systems on paper. Ravngard is the tool I wanted on every project.”
- The founder: computerised system validation engineer in GMP pharmaceutical manufacturing
- Hands-on validation of DCS, MES and process historian systems
- M.Sc. in Biomedical Engineering · works in English and Italian
Design-partner programme
We are looking for a few GMP sites in Europe to shape Ravngard with us.
- Guided pilot on one real system
- Direct line to the founder
- Influence on the roadmap
- Founding-partner terms
AI, carefully
Most validation vendors now lead with AI. We take a calmer position, because a GxP record has to be explainable to an inspector.
- No black-box AI in your GxP recordsRisk priorities, test depth and review dates come from documented, transparent rules you can verify.
- Suggest, never decideAny AI assistance we add will be opt-in and suggest-only. A qualified person always decides and signs.
- Logged like everything elseAI suggestions that are accepted will be recorded in the audit trail with who accepted them.
- Ready for EU GMP Annex 22We follow the draft Annex 22 on artificial intelligence, so you won't have to re-validate later.
Frequently asked questions
How do we validate Ravngard itself?
Ravngard is a configurable, GAMP 5 category 4 type system. We provide a supplier validation pack (functional specification, supplier risk assessment, test reports and release notes) and a built-in self-test you run in your own environment after every update. Most of your effort goes into testing your configuration and your processes, not the software itself.
Where is our data hosted?
The hosted service runs on servers in the European Union, with daily backups and regular restore tests. Each customer has its own tenant. You can also ask for a dedicated instance.
What does it cost?
We are finalising our pricing with our first design partners. Tell us how many sites and systems you have and we will send you a quote. Design partners get founding-partner terms.
Can we import our Excel system inventory?
Yes. The inventory register imports from Excel, so you start with the systems you already have. Exports to Excel work the same way.
Is Ravngard 21 CFR Part 11 and Annex 11 compliant?
No software is compliant on its own; compliance comes from the system plus your procedures. Ravngard provides the technical controls: unique accounts, password e-signatures with meaning, a secure audit trail, access by role and protected records. Our compliance page maps each requirement to a feature.
Can testers execute protocols on a tablet?
Yes. Execution is designed for screens of any size: one step at a time, with typed results, photos and attachments.
What happens to our data if we stop?
Your records are yours. You can export them at any time as Excel files and as a complete backup, and we agree retention and hand-over in the contract.
Who is behind Ravngard?
Ravngard is being founded by a computerised system validation engineer working in GMP pharmaceutical manufacturing in Italy. The company is in formation.
Let's talk about your next validation
Book a 30-minute walkthrough, ask for a free Annex 11 readiness review, or join the design-partner programme.