One platform for the whole lifecycle.
Requirements to release in one tool, built for smaller teams.
Get the inputs right
Most validation problems start in the URS and design. dAInta finds them before anything is built or tested.
The system shall record the user ID, date and time of every change to a batch record.
Audit trail records the user and timestamp of each change.
21 CFR 11.10(e): changes must not obscure previously recorded values. Neither the URS nor the vendor design says old values are kept.
Drafted: data integrity impact high. Mitigation allocated to OQ.
Edit a batch record and verify the audit trail shows user, timestamp, old value and new value.
Read and trace
- Reads your existing URS, specs and supplier manuals, including scanned pages
- Breaks out every requirement with a stable ID and traces it to design
- Every item opens the original document at the page it came from
Check before you test
- URS and design checked against regulations before any test is written
- Every requirement matched to the supplier’s capability, with evidence
- Same documents, same findings: checks run on versioned rule sets
Test only what matters
Risk decides what to test, and how hard. dAInta writes the tests; your engineers approve and run them.
AI risk assessment
- Functional risk assessment drafted from your requirements and design
- Mitigations allocated to FAT, SAT, IQ, OQ, SOPs or training
- Every risk checked for a test or control before testing starts
Tests and execution
- Test cases generated and traced across the full scope
- Digital execution with evidence and compliant e-signatures
- Streamlined AI-supported defect authoring and re-testing
Release and stay compliant
Release at the click of a button, and keep every system in a validated state.
Release
- Release reporting at the click of a button
- Trace matrix you can show an inspector at any time
- Embedded, compliant inventory management
Coming next
- Intelligent, integrated change management
- Change impact across requirements, risks and tests
- Periodic review on demand
See it on one of your systems
Run dAInta beside your current approach on one system or change, and measure the difference.