Your investigation is finished. The findings are signed off. But right now, in this moment, the regulator is standing in the corridor. Do you have a tamper-evident, timestamped, e-signed record that holds up to scrutiny — or a folder of emails and a spreadsheet held together with good intentions?
Trusted by QA teams in pharmaceutical and biotech
Purpose-built tools for QA professionals managing complex root cause investigations under regulatory scrutiny.
Five-phase structured RCA workflow with non-linear evidence gathering and analysis. Purpose-built for QA professionals under regulatory time pressure.
Proprietary six-domain causal factor framework: Human Factors, Equipment, Process, Environmental, Management System, and Supplier/Material.
FDA 21 CFR Part 11 and EU GMP Annex 11 baked in from day one. Tamper-evident records and compliant e-signatures on every action.
Cryptographically sealed, immutable investigation reports generated on demand. Accepted by MHRA, EMA, and FDA without reformatting or re-signing.
Secure, confidential witness submission channel. Protect informants with end-to-end encryption and zero-traceability back to contributor identity.
All data resident in the United Kingdom. UK GDPR and DPA 2018 compliant. EU and US data residency planned for Year 2 and Year 3 roadmaps.
Causara guides investigation teams through a structured, non-linear workflow with full audit trail at every step.
Open a new investigation, assign investigators, classify the event type, and set the regulatory classification. Every action is timestamped and attributed from the first second.
Collect evidence, interview witnesses, map contributing factors, and run root cause analysis using the six-domain taxonomy. Non-linear by design — return to any phase as the picture develops.
Submit for review, collect e-signatures from responsible parties, generate a PDF/A-3 report, and archive. Full chain of custody preserved for regulatory submission.
No hidden fees. No per-feature add-ons. Pick the tier that fits your organisation today.
For individuals evaluating Causara or managing a single investigation.
For regulated organisations running multiple simultaneous investigations with full CAR enforcement.
For large organisations with global operations, custom branding, and dedicated support requirements.
Straight answers from the Causara team.
Causara is built for quality assurance professionals, compliance officers, and investigation leads in pharmaceutical, biotech, medical device, food safety, and aerospace organisations that operate under regulatory oversight. If MHRA, EMA, FDA, or EU GMP compliance is part of your day-to-day reality, Causara was designed for you.
The Causara workflow has five phases: Initial Classification, Evidence Collection, Root Cause Analysis, CAPA Definition, and Sign-off. The process is intentionally non-linear — you can return to any earlier phase as the investigation develops. Evidence is gathered first, then analysed, and every modification is attributed and timestamped in the audit trail.
We had a finding last year. I cannot afford another one. Paper-based records get lost. Shared spreadsheets get edited after the fact — sometimes with the best intentions, sometimes without. Causara's audit trail is timestamped from second one. Every edit is attributed to a named user. E-signatures meet FDA 21 CFR Part 11 requirements. When the inspector asks, you pull the PDF/A-3 and it holds up.
A Causara PDF/A-3 report is a cryptographically sealed document generated on demand — not stored on the platform, so there is no version-control problem. It contains the full investigation record: timeline of events, evidence attachments, root cause analysis using the six-domain taxonomy, CAPA definitions, and complete sign-off history with e-signatures. Designed to be submitted directly to MHRA, EMA, or FDA without reformatting.
The Free tier gives you full platform access for one user and one investigation — no credit card, no time limit. Run a real investigation end-to-end. Generate a real PDF/A-3 report. When you are confident the platform does what you need, upgrade. If it does not, you have lost nothing.