Every decision, explained, evidenced and owned.
Traceura is decision intelligence for quality and validation teams. It connects your procedures, evidence and expert judgement, so every change-impact, validation and release decision is fast to make and easy to defend.
LIMS upgrade — stability module
Proposed change · Quality SystemsGxP-impacting. Targeted validation: regression OQ on stability workflows; full IQ not required.
Designed around the frameworks your auditors use
GAMP® 521 CFR Part 11EU GMP Annex 11ICH Q9EU AI ActISO/IEC 42001Your systems record what happened. Not why.
Quality and validation records capture what changed, when and who signed. The reasoning — why a requirement applied, why that validation scope was chosen, which evidence justified it — lives in experts' heads, spreadsheets and email threads.
So teams rebuild rationale for every audit, similar changes get assessed differently, and hard-won judgement walks out the door when people move on.
Make faster quality decisions you can defend
Traceura takes the slow, manual work out of regulated decisions, without taking people out of them.
Assess change impact
See which systems, requirements and controls a change touches, and why.
- Impact reasoned against your SOPs
- System registry outranks the model
- Consistent across similar changes
Right-size validation
A proportionate, risk-based validation scope, with the justification already written.
- Risk-based, GAMP 5 aligned
- Deliverables matched to your matrix
- Rationale ready for the file
Close evidence gaps early
Spot missing or weak evidence before it becomes a deviation or an inspection finding.
- Each requirement mapped to evidence
- Gaps flagged before review
- Waivers recorded with reasons
Release with confidence
A clear view of whether a release is ready, and exactly what still stands in the way.
- Readiness at a glance
- Open items with owners
- Sign-off tied to evidence
Be inspection-ready
Answer "why did you decide that?" in minutes, with the full chain from decision to source.
- Decision → rule → requirement → page
- Tamper-evident audit trail
- Exportable decision dossier
Keep expert judgement
Capture how your best reviewers reason, so it stays when they move on.
- Every edit and override explained
- Institutional knowledge retained
- Faster onboarding of new reviewers
Retrieve. Reason. Recommend. Record.
A governed pipeline from raw documents to a defensible, signed decision.
Retrieve
Pull the procedures, requirements and evidence that matter for this change.
Reason
Apply your rules deterministically, with the source of every fact shown.
Recommend
Propose an assessment and scope, explained in plain language.
Record
Capture the human decision and its rationale in a tamper-evident trail.
Built for the people who sign their name to decisions
Pharma, biotech and medical-device teams carrying the weight of regulated change.
Works alongside the systems you already run
Heads of CSV & validation
Consistent, proportionate validation scope across every system.
Quality assurance & QA leads
Reviews that start from evidence, not a blank template.
Digital quality & IT quality
Faster change throughput without loosening control.
Regulatory & quality systems
A defensible record of why, ready for any inspector.
Governance isn't a feature we added. It's the product.
Most AI tools ask regulated teams to trust a black box. Traceura is built the other way round.
Your rules outrank the model
Your procedures and system registry decide what's GxP-critical. The AI can't override them, and unknowns stay unknown.
Explainable by design
Every recommendation shows the rule, requirement and source page behind it. No unexplained answers.
Separation of duties, enforced
No single account can raise and approve the same decision. Controls are built in, not left to policy.
Isolation at the database
Your data is isolated by the database itself and fails closed, so a misconfigured screen can't leak it.
Built by GxP practitioners
Designed from real computerised-system validation work, not adapted from a generic AI platform.
Ready to be validated
Refusal tests and golden cases written to support your IQ/OQ, so you can validate the validator.
Make your next inspection the easiest one yet
See how Traceura turns a change request into a decision you can explain, evidence and defend.