From controlled documents and CAPAs to eTMF, GDPR, electronic signatures, and audit trails — manage your entire regulated ecosystem in one platform. Powerful enough for multinationals, simple enough for startups.
Purpose-built for regulated environments where every signature, every revision, and every CAPA matters.
Full SOP / Policy / Form / Record management with versioning, track-changes, threaded comments, citations, and Word/PDF round-trips.
Multi-step electronic signature with OTP/PIN/qualified methods, signature meanings, certificate PDF + QR verification.
Configurable approval flows for documents, CAPAs, change controls and templates. Multi-approver, parallel/sequential, with reminders.
Trial Master File with DIA Reference Model, expected document lists, QC reviews, multi-version artifacts, audit-ready ZIP exports.
Per-organization database isolation, role-based access scoped per tenant, SSO via Keycloak, two-factor authentication.
Every action attributed, timestamped, tamper-proof via DB triggers. Full record hash chain. 21 CFR Part 11 compliant.
Every module you need to run a quality system, integrated end-to-end. No add-ons, no plug-ins, no surprises.
Versioning · track-changes · comments · citations · Word/PDF
SOP/Policy/Form templates with placeholders & assignments
Multi-step e-signature with reviewers and reminders
Investigations, root cause, effectiveness checks
Impact assessment, tasks, multi-approver gating
Internal/regulatory/mock audits, findings, CAPAs linked
ISO 14971 / ISO 31000 / ICH E6(R3) frameworks
Programs, records, attestation, competency assessment
DIA RM, expected document list, QC, audit-ready ZIP
Studies, sites, protocol amendments, regulatory submissions
BPMN editor, RACI, ISO 9001 §4.4 process interactions
DSAR, breach 72h, RoPA, DPIA, retention policies
Qualification, audits, contracts, GDPR linkage
Time-limited document sharing with watermarks & NDA
21 CFR Part 11 + QR-verifiable signature certificates
REST API + webhooks, Keycloak SSO, 600+ endpoints
From zero to hero
World-class quality management isn't reserved for multinationals anymore. We built Cobalt to be powerful where it matters and simple where it doesn't. Sign up today, run a real QMS by next week.
No complex setup, no IT department required. Sign up, configure your organization, start managing quality immediately.
Transparent pricing that scales with your needs. No hidden fees, no expensive consultants, no surprises.
Pre-built templates, automated workflows, complete audit trails. You're always inspection-ready, no last-minute scramble.
Every record is signed, every change is logged, every export is reproducible. Cobalt is engineered for regulated environments where the answer to "who did what, when?" must always be one click away.
Tamper-proof DB-trigger chain on every quality-relevant table. Full attribution, IP, user-agent, content hash.
OTP / PIN / qualified electronic signatures with signature meanings. Certificate PDFs and QR-verifiable hashes.
Controlled documents, design history, technical file structure, periodic review, post-market surveillance.
Data minimization, configurable retention, DSAR workflow, breach 72h notification, third-party processor registry.
Whether the question comes from a notified body, a customer audit, or your QA director, Cobalt has it covered: who did what, when — and on which version.
Anywhere a quality system has to be audit-ready, traceable, and easy to live in.
Software-as-a-Medical-Device teams who need IEC 62304 software lifecycle, design records, and 21 CFR Part 11 signatures from day one.
Brand owners outsourcing manufacturing who must control supplier qualification, CAPAs, and the full eTMF — without an in-house QA army.
EU MDR / FDA QSR manufacturers who need controlled documents, design history files, post-market surveillance and audit-ready exports.
Sponsors and CROs running studies who need eTMF/eISF, protocol amendments, regulatory submission tracking, monitoring visit logs.
Lab SOPs to clinical study documentation, equipment & calibration tracking, ISO 14971 risk for research programs — GxP-grade rigor without enterprise overhead.
Donor compliance, organizational policies, internal audits, GDPR for beneficiary data — the same rigor as regulated industries, none of the complexity.
Services
Expert consultancy and QA services that complement Cobalt. We don't just sell software — we plug into your team where you need us.
Comprehensive gap analysis against ISO 13485, EU MDR, FDA QSR, and other regulatory standards. Know exactly where you stand and what you need.
On-demand quality assurance expertise without the overhead. Flexible support from junior to principal-level QA professionals — paired with the platform.
Tailored regulatory consulting for your specific needs. From technical file reviews to full certification support — pay only for what you use.
Pick the plan that matches your maturity. Migrate later — your data, audit trail, and validation evidence move with you.
Tell us about your needs and we'll get back to you within one business day.