Certigo
Your QMS should work as hard as your team does.
Certigo is an AI-powered eQMS and ALM built for medical device and life sciences companies that can't afford compliance gaps. Document control, electronic signatures, risk management, design controls, change requests, and audit trails — all in one system.
Certigo is currently in private beta. Get in touch if you'd like early access.
Most QMS platforms were built for auditors. Not for the people doing the actual work.
The average medical device company spends 17% of its quality team's time searching for documents, reconciling versions, and chasing approvals — before a single word of actual quality work gets done.
The tools you're using were designed before AI existed, before remote teams were the default, and before FDA began scrutinising software-as-a-medical-device at the same level as hardware.
The compliance gap isn't a process problem. It's a tooling problem.
One platform. Every quality process. Compliance by design.
Certigo replaces the patchwork of spreadsheets, shared drives, and siloed tools with a single, structured environment where every action is tracked, every document is versioned, and every signature is legally binding under 21 CFR Part 11.
Zero validation scripting required. Certigo ships with a full GxP Computer System Validation (CSV) package — RTM, pre-written IQ/OQ/PQ protocols, and automated test cases mapped to ISO 13485 §4.2.4, 21 CFR §820.40, 21 CFR Part 11, and GAMP 5. Your CSV work is done before you write a single test script.
Built for every regulated workflow
AI-generated training verification, on every SOP.
When a document goes effective, Certigo can generate a 5–7 question quiz from its content — multiple choice, true/false, and multi-select — in seconds. Team members must pass before a training record is created. There is no way to log completion without passing the gate.
When a document is revised and a new version is approved, the quiz increments automatically. Anyone who passed the previous version has a pending training task for the new one the moment it goes effective.
This is exactly what ISO 13485 §6.2 and §4.2.4(b) require — and it happens without a quality manager manually maintaining a training matrix.
ISO 13485 §6.2 — Human resources
Training records per document, per version, per user. Evidence generated automatically.
ISO 13485 §4.2.4(b) — Re-train on change
Version-aware quiz invalidation. New revision = new training requirement.
21 CFR Part 11 §11.10(g) — Authority checks
Training confirmation requires password + OTP re-authentication.
21 CFR Part 11 §11.10(e) — Audit trail
Every training completion is an immutable, timestamped audit record tied to the specific document version.
Built to pass your validation. Not just your audit.
Certigo ships with a validation package — not a "validation support guide" — actual validation artifacts. RTM, automated test suite, infrastructure certification, and IQ/OQ/PQ templates.
| Requirement | How Certigo addresses it |
|---|---|
| §4.2.4(a) | Enforced approval workflow. No document reaches Effective without designated approver signature. |
| §4.2.4(b) | Revision control with major.minor versioning. Every update triggers a new approval cycle. |
| §4.2.4(h) | Automatic obsolescence on new revision becoming Effective. Obsolete documents cannot be retrieved as current. |
| §4.2.5 | Confidential workspace designation. Access restricted to named users regardless of workspace role. |
| §6.2 | Per-document training with AI-generated quizzes, configurable passing threshold, version-aware re-training, and exportable Training Matrix PDF. |
| Requirement | How Certigo addresses it |
|---|---|
| §11.10(a) | RTM, automated test suite, and validation package provided with every subscription. |
| §11.10(b) | PDF export with embedded signature block. Record locking prevents post-signature alteration. |
| §11.10(e) | Immutable, computer-generated, UTC-timestamped audit log. Captures all create/modify/delete events. |
| §11.10(g) | Re-authentication required at signature. Deactivated users blocked at API level. |
| §11.50(a) | Printed name, server timestamp, and signing reason (Review/Approval/Authorship) embedded in every signature. |
| §11.70 | SHA-256 binding of signature to specific document version. Content modification invalidates the link. |
GxP regulations (GMP, GLP, GCP) require that computerised systems used in regulated activities are validated — that they demonstrably do what they claim, consistently and traceably. Certigo's CSV package satisfies the GAMP 5 framework requirements for a Category 4 configured software application.
| Requirement | How Certigo addresses it |
|---|---|
| Supplier / vendor qualification | Supplier quality module captures vendor assessments, qualification status, and linked quality events — satisfying the GAMP 5 supplier assessment requirement. |
| URS & functional specification | User needs and software requirements are first-class versioned records in the ALM layer, with full traceability to design outputs and verification evidence. |
| IQ / OQ / PQ protocols | Pre-written installation, operational, and performance qualification protocols are included in the validation package — reviewed, executed, and signed within Certigo itself. |
| Change control for validated systems | All changes to validated configurations follow the enforced change control workflow: impact assessment, CCB approval, and post-implementation verification before closure. |
| Periodic review | Scheduled document review cycles with mandatory re-approval. Overdue reviews surface in the quality manager dashboard and are blocked from bypassing the approval gate. |
| Audit trail for regulated systems | Every system action — configuration changes, role assignments, document transitions — is written to the immutable, UTC-timestamped audit log. No admin override exists. |
From setup to first approved document in one day.
Trusted by quality teams in regulated industries.
"We went from a SharePoint-based QMS that took three weeks to prepare for audit, to Certigo. Our last FDA inspection took two days and zero corrective actions."
Quality Director, Series B medical device company
"The Part 11 validation package alone saved us six weeks of consultant time. We had our IQ/OQ done in three days."
Regulatory Affairs Lead, SaMD startup
"Having requirements, verification, and anomalies in the same system as our quality events completely changed how we manage post-market surveillance. Everything is traceable. Nothing gets lost."
VP of Engineering, combination product company
Certigo is currently in private beta.
We're working closely with a small number of medical device and life sciences teams before opening up more broadly. If you'd like early access, tell us a bit about your team and we'll get back to you.