Documentation and quality systems, built to hold up under inspection.
Software for pharmaceutical, biologics and healthcare organisations that need their GMP environment — batch records, deviations, CAPA, validation — to stay inspection-ready every single day, not just before an audit.
For Quality teams
Run batch release, deviations and CAPA from one connected system, with approvals routed the way your SOPs already require.
For Validation & CSV engineers
Generate risk-based IQ/OQ/PQ scripts from your URS, and get audit-trail evidence for every configuration change.
For Auditors & inspectors
A read-only, timestamped record of who did what and why — structured so a records request takes minutes, not days.
A modern platform for GMP compliance.
Quality documentation, computerised system validation and applied AI aren't separate tools bolted together — they read and write to the same validated data layer.
GMP Documentation & eQMS
SOPs, batch records, deviations, CAPA, change control and training — versioned, routed and e-signed in one connected quality management system.
- Electronic batch records with in-line calculation checks
- Deviation → CAPA linkage with ICH Q9 risk scoring
- Controlled-document lifecycle: draft, review, effective, retire
- Training assignment tied to current SOP version
Validation & Computerised Systems
CSV/CSA documentation, e-signatures and audit trails engineered to Part 11 and Annex 11 from day one.
Deep AI for Healthcare
Document intelligence, anomaly detection and predictive risk scoring — always with a human decision-maker in the loop.
Five frameworks. One control set.
Rather than bolting compliance on after the fact, every workflow, form and permission in the platform traces back to a specific regulatory clause — so your validation package can point to exactly where a control lives.
Electronic Records & Signatures
Audit trails, access controls and legally binding e-signatures modelled directly on §11.10 and §11.50 — every entry tied to a user, a timestamp, and a reason.
cGMP for Finished Pharmaceuticals
Batch production records, laboratory controls, and equipment logs structured to Subpart F and J — built for the paperwork FDA investigators actually pull.
Sterile Medicinal Products
Contamination control strategy documentation, environmental monitoring trends and interventions logged against the 2022 revision's CCS requirements.
Qualification & Validation
URS, DQ, IQ, OQ, PQ and periodic review templates that generate a traceable validation lifecycle for equipment, systems and processes.
Quality Risk Management
FMEA and risk-ranking tools built into deviation, change control and CAPA workflows, so risk assessment isn't a separate spreadsheet exercise.
Computerised Systems & Data Integrity
Attributable, legible, contemporaneous, original, accurate records by default — the same data-integrity backbone that Annex 11 and Part 11 both call for.
How a deployment actually gets validated.
This is the real sequence your Quality Unit signs off on — not a marketing timeline. Each stage produces evidence that feeds your own validation master plan.
Gap & risk assessment
We map your current SOPs and systems against Part 11, Part 211, Annex 1, Annex 15 and ICH Q9.
Workflow configuration
Forms, approval chains and e-signature routing configured — no custom code — against your URS.
IQ / OQ / PQ execution
Qualification scripts run jointly with your QA team, producing signed evidence for your validation file.
Live GMP operations
Batch records, deviations, CAPA and training run in production, captured to the audit trail in real time.
Continuous review
Scheduled periodic review, access recertification and trend analysis keep the system current.
AI that reads your quality data — and shows its work.
Deviation reports, environmental monitoring trends and batch history accumulate faster than any Quality Unit can manually review. Our models surface what's worth a human's attention, with the source record always one click away.
- 01 Document intelligence — search and summarise SOPs, deviations and CAPA records in plain language, with citations back to the source document.
- 02 Anomaly detection — flags unusual environmental monitoring or process trends against historical baselines, before they become an OOS result.
- 03 Predictive risk scoring — ranks open batches and deviations by likelihood of escalation, so QA reviewers triage the highest-risk items first.
- 04 Submission drafting support — assembles first-draft narrative sections from structured batch and validation data for regulatory review.
Every AI-generated output is labelled, versioned and routed for human QA review before it becomes part of a GxP record — models are validated as computerised systems in their own right, not treated as a black box exception to Part 11.
Regulated manufacturing and care delivery, in one platform.
The design philosophy behind the platform.
"The question we ask about any new feature isn't whether it's convenient — it's whether it would hold up in front of an investigator. That's the bar."
"Most eQMS tools digitise a paper process and call it done. We started from the inspection checklist and built backwards from there."
Questions QA leads actually ask us.
If your question isn't here, it becomes the first item on the gap-assessment call.
Does the software replace our Quality Unit's judgment?
No. The platform enforces workflow, routing and audit-trail integrity — every deviation disposition, CAPA closure and batch release still requires a qualified reviewer's signature. We provide the guardrails; your QU makes the call.
How long does validation actually take?
Typical gap assessment through PQ sign-off runs 8–14 weeks depending on site complexity and how many legacy SOPs need remapping. You get a firm timeline after the 02 / CONFIGURE stage, once your URS is locked.
Can it integrate with our LIMS, MES or ERP?
Yes — validated API and file-based integrations exist for common LIMS, MES and ERP platforms. Each integration point ships with its own IQ/OQ evidence, since interfaces are GxP-relevant too.
What happens to our records if we ever migrate off the platform?
A full export in a vendor-neutral, human-readable format (PDF/A plus structured data) is available on demand — not held hostage at contract end. Your audit trail leaves with your records.
Is the AI layer itself validated, or is it a black box?
The models are treated as computerised systems in their own right — versioned, tested against defined acceptance criteria, and every output routed for human QA review before it touches a GxP record.
Ready to make your next inspection a formality?
Tell us about your site, your current systems, and which frameworks you need to demonstrate. We'll walk through a gap assessment before you commit to anything.