Slow
Requirements, risk assessments and test scripts are drafted, reviewed and approved by hand. Validation becomes the critical path on capital projects and system changes.
Validation lifecycle management for Life Sciences
Find the gaps before you write a single test.
dAInta reads your URS and vendor design documents, flags what is missing, maps every requirement to what the system actually does and builds traceable test protocols. Validation starts right first time and takes a fraction of the effort.
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.
Data integrity risk rated high. Mitigation allocated to OQ.
Edit a batch record and verify the audit trail shows user, timestamp, old value and new value.
Designed around
- 21 CFR Part 11
- EU GMP Annex 11
- GAMP® 5 (2nd ed.)
- FDA CSA
- ICH Q9(R1)
Savings estimator
What could dAInta save your validation team?
Set your yearly workload to see the time and cost you could take out of protocol drafting, review and approval.
Estimated saving per year
€153,000
- Hours freed
- 2,385
- Person-days
- 298
- Protocols a year
- 18
Illustrative estimate based on dAInta’s costing of a single protocol from drafting to approval across five roles (author, business owner, automation, validation and quality), using Irish salary levels plus 25% employer costs. Test execution is not included. Your own figures will vary.
The problem
Validation still runs on documents written by hand.
Life Sciences companies must prove that every system, piece of equipment and piece of software is fit for use, and keep proving it for the life of the asset. Most of that work is manual.
Expensive
Every new system means more specialist hours. Teams bring in contractors to write documents that look a lot like the last project’s.
Found too late
Gaps in the URS or design surface during test execution or audit, when they cost the most to fix and cause deviations and rework.
How dAInta works
One connected thread from requirement to release.
Each step feeds the next. When a source document changes, everything built on it is flagged as out of date, so nothing stale reaches an approved protocol.
Ingest
Upload your URS, vendor design specifications and manuals as they are, including scanned pages. Every requirement and capability is extracted and linked to the page it came from.
Find the gaps
Requirements are checked for anything missing, ambiguous, duplicated or unowned. Findings go into an improvements report so the source document can be fixed.
Map to the vendor design
Each requirement is matched to the vendor capability that meets it, as a full, partial or missing match, with the evidence shown. You confirm every match.
Check risk coverage
Your functional risk assessment is read in and every risk is checked for a test or control, so gaps in coverage are found before testing starts.
Build the tests
Test protocols are built top-down, from test groups to titles to steps, with your approval at each level. FAT and SAT results can be leveraged in IQ and OQ.
Execute and report
Run approved tests with every result attributed and recorded as evidence. Reports and the traceability matrix are built from approved runs and exported to Word.
What makes dAInta different
Most validation tools manage your tests. dAInta checks your inputs first.
A test can only be as good as the requirement and design behind it. dAInta checks the URS, the vendor’s design and your risk assessment against each other before any test is written, so gaps are found at the cheapest point to fix them.
| Document-based VLMS | dAInta | |
|---|---|---|
| URS review | Manual, by reviewers | Findings flagged automatically, each linked to its page |
| Vendor design vs URS | Cross-checked by hand | Every requirement mapped to a vendor capability, with evidence |
| Risk coverage | Checked late, if at all | Every risk checked for a test or control before testing |
| Test protocols | Authored by hand | Built top-down for you to review and approve |
| Traceability matrix | Compiled by hand at the end | Built as you go and kept current when documents change |
Who it’s for
Built for teams without a validation department of fifty.
Pharma and biotech
Scale-ups validating their first GMP systems without a large validation department.
Learn moreMedical device
Teams that need software and equipment validation done properly and quickly.
Learn moreCDMOs and CROs
Organisations validating for many clients who need consistent, defensible output.
Learn moreEquipment and system suppliers
Suppliers who provide validation packages with the systems they deliver.
Learn moreTrust
Output you can defend in an audit.
dAInta is built so every result can be checked, reproduced and traced back to its source. Nothing it proposes takes effect until a person approves it.
Our approach to compliance- Every fact traces to its page. Click any requirement, capability or finding to open the original document at the page it came from.
- Nothing invented. Text the AI extracts is checked word for word against the source. Anything that doesn’t match is rejected.
- Same documents, same findings. Findings come from versioned rule sets, so a re-run gives the same answer.
- People approve. Matches, tests and reports take effect only when a person confirms them, with a full audit trail of who did what and when.
Join the early access programme
We are working with a small group of Life Sciences teams to shape the first commercial release. Early access customers get preferential terms and a direct line to the product team.