Digitize your QMS with AI
Replace paper binders with an AI‑assisted eQMS that finds compliance gaps, predicts risk, and keeps you perpetually audit‑ready.
AI Insight: “CAPA recurrence trending in Mixing Line 2. Recommend adding effectiveness checks and refreshing training for SOP‑QMS‑014.”
From paper to AI‑ready eQMS
Stand up core modules fast, then layer predictive analytics and automation.
Document Control
Versioning, training links, change control, read & understand, and audit trails.
eQMS Workflows
Deviations, CAPA, Complaints, Change Control, Supplier Quality, Audits.
Risk & AI Insights
AI flags compliance gaps, predicts risk, and recommends mitigations.
Dashboards & KPIs
Cycle time, CAPA effectiveness, training status, and audit readiness—live.
Secure Data Pipelines
EMR/LIMS/eSource integrations with full traceability and Part 11 compliance.
eSignatures & Validation
Part 11‑compliant eSignatures, validation packs, and CSV (GAMP 5).
How the closed‑loop works
Ingest
Securely ingest docs, records, logs (PDF, CSV, API) from legacy systems and paper scans.
Analyze
AI maps content to standards, finds gaps, and scores risk by process/line/site.
Act
Auto‑create CAPA, Change, or Training tasks with owners, due dates, and effectiveness checks.
Learn
Outcomes feed back to improve signals—reducing recurrence and audit findings over time.
Aligned to your frameworks
- ✓ FDA 21 CFR Part 11/210/211/312/820
- ✓ ISO 13485 / ISO 14971
- ✓ GxP (GMP/GCP/GLP)
- ✓ EU MDR / IVDR
- ✓ HIPAA / HITRUST
- ✓ SOC 2 Type II
Estimate your ROI
Quick, conservative calculator for time and cost savings from digitization & AI assistance.
What’s included
- ✓ Discovery, URS/FS/DS, and a phased rollout plan
- ✓ Core modules: Docs, Training, Deviations, CAPA, Change Control, Audit
- ✓ AI risk scoring mapped to ISO 13485, Part 11, MDR
- ✓ Validation package (IQ/OQ/PQ) and CSV deliverables
- ✓ Dashboards, KPIs, and effectiveness checks
- ✓ Integrations: Veeva, MasterControl, ValGenesis, TrackWise, Jira, LIMS/EMR
Security by design
SSO (SAML/OIDC), RBAC, encryption in transit & at rest, and least‑privilege access.
Compliance ready
Audit trails, immutable logs, electronic signatures, and periodic reviews.
Data governance
Provenance, data lineage, and retention policies aligned with your QMS.
FAQ
1. How does the closed‑loop AI work?
We ingest QMS records (docs, deviations, CAPA, audits), learn your patterns, and surface predicted risks vs. standards (ISO 13485, Part 11, MDR). Recommendations generate tasks that feed back into CAPA and training—closing the loop.
2. Can you integrate with our existing tools?
Yes. We commonly integrate with Veeva, MasterControl, ValGenesis, TrackWise, Jira, Confluence, SharePoint, and LIMS/EMR systems via APIs or secure data agents.
3. What about validation?
We deliver validation documentation (URS/FS/DS, IQ/OQ/PQ, risk assessments) aligned with GAMP 5 and 21 CFR Part 11, plus periodic review templates.
4. Security & privacy?
SOC 2 and HIPAA‑aligned architecture, SSO (SAML/OIDC), role‑based access, encryption at rest and in transit, and detailed audit logs.
5. Implementation timeline?
MVP in 6–10 weeks for core modules; phased rollout for advanced AI and complex integrations.