Quality Management,
without Bureaucracy.
With aChiral Cobalt, you have the entire regulatory ecosystem within a single eQMS. It integrates and automates SOPs, CAPA, eTMF, electronic signatures, and audit trails, reducing the risk of non-compliance through a single, structured platform.
Digitize your quality system and achieve regulatory compliance in a single environment.
Bring structure, traceability, and control to your quality processes with a platform designed
to be operational quickly and to scale with the growth of your organization.
ACHIRAL COBALT
The advanced eQMS platform
for managing, controlling, and ensuring compliance of quality processes.
aChiral Cobalt simplifies the quality system in regulated organizations by combining document management, approval workflows, and traceability into a single platform. It includes features for document control, CAPA, audits, change control, training, risk management, and electronic signatures, ensuring compliance and enabling collaboration across quality, regulatory, and operations teams.
COMPLETE eQMS
Built for regulated environments,
integrated end-to-end.
No add‑ons, no plug‑ins, no surprises. aChiral Cobalt includes everything you need
to manage a GxP-compliant quality system, already validated and production‑ready.
Document Lifecycle
Complete management of SOPs, policies, forms, and records with versioning, track changes, threaded comments, citations, and Word/PDF round‑trips. Every revision is tracked, and every signature is certified.
21 CFR Part 11 Signatures
Multi-step signing with OTP/PIN/qualified methods, signature meanings, certified PDF and QR verification. Fully compliant with 21 CFR Part 11 and EU Annex 11.
Workflow & Approvals
Configurable workflows for documents, CAPA, change control, and templates. Multi-approver, sequential or parallel, with automatic reminders and escalations.
Multi-Tenant by Design
Database isolation per organization, role-based access scoped by tenant, SSO via Keycloak, and two-factor authentication.
eTMF / eISF
Trial Master File with DIA Reference Model, expected-document list, QC review, multi-version artifacts and audit-ready ZIP export. Compliant with ICH E6(R3).
Immutable Audit Trail
Every action is attributable, time‑stamped, and tamper‑evident via DB triggers. Hash chain with full record. Compliant with 21 CFR Part 11.
And much more: Risk Management · Training · Audit Management · Supplier Mgmt · GDPR · Process Mapping · Data Rooms · API
BUILT FOR VERIFIABILITY
Built-in traceability.Continuously verifiable compliance.
Developed to meet the rigorous standards of the Life Sciences sector, aChiral Cobalt ensures full traceability, verifiability, and reproducibility of every single system action. It guarantees flawless, continuously up-to-date documentation, eliminating pre-audit inefficiencies and ensuring complete control during inspections, Notified Body assessments, and internal audits.
Designed for compliance, traceability, and growth.
- Operative in just minutes — no complex setup, no IT department required. Register your organization and start managing quality immediately.
- Audit-ready from day one — predefined templates, automated workflows, complete audit trail. You're always prepared for an inspection, with no last-minute scrambling.
- Transparent pricing — Prices that adapt to your needs. No hidden fees, no costly consultants, no surprises.
WHO IT'S FOR
Quality audit‑ready,
easy to manage.
aChiral Cobalt is designed for any organization operating in regulated environments,
from SaMD startups to global pharmaceutical companies.
SaMD Developers
Teams building Software-as-a-Medical-Device that require IEC 62304 lifecycle, design records, and 21 CFR Part 11 signatures from the first sprint.
Virtual Manufacturers
Brand owners who outsource manufacturing and need to manage supplier qualification, CAPA, and eTMF without an internal QA department.
Medical Device Producers
EU MDR / FDA QSR manufacturers with controlled documentation, design history files, post-market surveillance, and export‑ready audit packages for Notified Bodies.
Clinical Trials & CROs
Sponsors and CROs with eTMF/eISF, protocol amendments, regulatory submission tracking, and monitoring visit logs compliant with ICH E6(R3).
Research Foundations
Lab SOPs, clinical documentation, instrument calibration, and ISO 14971 risk management — GxP rigor without enterprise overhead.
Non-Profit Organizations
Donor compliance, organizational policies, internal audits, and GDPR for beneficiary data — the same rigor as regulated industries, without the complexity.
BEYOND THE PLATFORM
Not just software.
We’re part of your team.
Expert consulting and QA services that complement aChiral Cobalt.
We don’t just sell software; we integrate with your team wherever you need us.
QMS Assessment
Comprehensive gap analysis against ISO 13485, EU MDR, FDA QSR and other regulatory standards.
- Gap analysis report
- Compliance scoring
- Prioritized action plan
- Cost & timeline estimates
QA as a Service
On-demand quality assurance expertise. Flexible support from QA professionals working seamlessly with the platform.
- Document review & approval
- Audit preparation & support
- End-to-end CAPA management.
- Regulatory submissions
Ad-hoc Consultancy
Tailored regulatory consulting to meet your specific needs. From technical file preparation to full certification support.
- Technical file preparation
- Clinical evaluation support
- Contact with the notified body
- Custom training
