aChiral Cobalt - Enterprise Quality Management System

Who We Serve

Built for Your Industry

Whether you're an early-stage startup, developing software, managing virtual manufacturing, or producing medical devices, we have the tools you need to stay compliant.

For Innovators

From Prototype to Hero

You have the vision—we provide the regulatory roadmap. Start with gap analysis, choose your pathway, and let our pre-configured templates guide you from concept through certification.

Start Your Journey →

12 pathway bundles 8 lifecycle phases

SaMD Developers

Software as a Medical Device requires rigorous documentation. Our platform provides a full IEC 62304 software lifecycle with status state machines, SOUP tracking, release gates, and requirements traceability matrices.

Full IEC 62304 software lifecycle
SOUP/COTS component tracking
ISO 14971 risk management
Clinical evaluation reports

Virtual Manufacturers

Outsourcing production doesn't mean outsourcing responsibility. Manage your supplier network, maintain design control, and ensure quality across your entire supply chain.

Supplier qualification & audits
Design history file (DHF)
Bill of Materials (BOM) management
Contract manufacturer oversight

Medical Device Producers

From Class I to Class III devices, manage your entire quality system. Complete documentation for FDA 510(k), EU MDR technical files, post-market surveillance, vigilance reporting, and equipment calibration.

UDI, lot traceability & DHR
PMS plans, PSUR & vigilance
Equipment & calibration tracking
Complaint & FSCA management

BEYOND MEDICAL DEVICES

QMS for Every Mission

Quality management isn't just for medical devices. Our platform adapts to any organization that values compliance, traceability, and continuous improvement.

Non-Profit Organizations

Manage donor compliance, organizational policies, and internal audits with the same rigor as regulated industries — without the complexity.

Document Control — Policies, bylaws & procedures
Training Management — Staff & volunteer qualifications
Audit Management — Grant audits & internal reviews
GDPR & Privacy — Donor & beneficiary data protection

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Research Foundations

From lab SOPs to clinical study documentation, maintain GxP-grade quality and data integrity across every research program.

Equipment & Calibration — Lab instrument tracking
CAPA Management — Research deviation handling
Risk Management — ISO 14971 for research programs
Secure Data Rooms — Collaborate with external partners

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WHY ACHIRAL COBALT

Enterprise Quality, Startup Simplicity

We believe every organization deserves access to world-class quality management tools. That's why we built aChiral Cobalt to be powerful enough for multinationals, yet simple and affordable enough for startups.

Up and Running in Minutes

No complex setup or IT department required. Sign up, configure your organization, and start managing quality immediately.

Affordable for Everyone

Transparent pricing that scales with your needs. No hidden fees, no expensive consultants, no surprises.

Audit-Ready from Day One

Pre-built templates, automated workflows, and complete audit trails mean you're always ready for regulatory inspections.

5 min

Average setup time

80%

Less paperwork

100+

Ready templates

24/7

System availability

Loved by quality professionals

Features

Everything You Need

A complete quality management platform with 40+ modules covering document control, regulatory compliance, product lifecycle, and continuous improvement.

Core Quality Management

Document Control

Version control, approval workflows, and automatic distribution. Never worry about outdated documents again.

CAPA Management

Track corrective and preventive actions with root cause analysis, effectiveness verification, and trend reporting.

Electronic Signatures

21 CFR Part 11 compliant e-signatures with multi-factor authentication and complete audit trails.

Training Management

Track competencies, manage training programs, and ensure everyone is qualified before accessing controlled documents.

Change Control

Structured change management with impact assessment, approval routing, and implementation tracking.

Audit Management

Plan, execute, and track internal, regulatory, and mock audits. Manage findings and link directly to CAPAs.

Regulatory & Compliance

New

Complaint Management

QR code intake points, investigation checklists, MDR reporting, and auto-CAPA creation for regulatory compliance.

Nonconformance (NCR)

Capture, investigate, and resolve nonconformances with disposition workflows and CAPA linkage.

Risk Management

ISO 14971 risk matrices, hazard analysis, severity/probability scoring, and mitigation tracking with CAPA integration.

New

GDPR & Privacy

Processing activities register, DSAR management, consent tracking, breach notifications, and DPIAs.

Supplier Management

Supplier qualification, performance scoring, audit scheduling, and approved supplier list management.

Gap Analysis

Assess compliance gaps against ISO 13485, EU MDR, and other standards with scoring and action plans.

Product Lifecycle & Device Management

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Software Lifecycle

IEC 62304 compliant lifecycle with status state machines, SOUP tracking, release gates, and requirements traceability.

New

Post-Market Surveillance

PMS plans, vigilance reporting, PSUR generation, FSCA management, and trend analysis per EU MDR Article 83-86.

New

Clinical Evaluations

Clinical evaluation reports (CER), literature reviews, clinical data management, and PMCF per EU MDR Annex XIV.

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Equipment & Calibration

Equipment lifecycle management, calibration scheduling, maintenance records, and product linking.

UDI & Traceability

Unique device identification, lot tracking, production orders, DHR generation, and EUDAMED-ready data export.

Secure Data Rooms

Share documents securely with external parties for audits, due diligence, and regulatory submissions.

SERVICES

Beyond the Platform

Expert consultancy and QA services to complement your quality management journey. We don't just provide software—we provide expertise.

QMS Assessment

Comprehensive gap analysis against ISO 13485, EU MDR, FDA QSR, and other regulatory standards. Know exactly where you stand and what you need.

✓ Gap analysis report
✓ Compliance scoring
✓ Prioritized action plan
✓ Cost & timeline estimates

QA as a Service

On-demand quality assurance expertise without the overhead. Flexible support from junior to principal-level QA professionals.

✓ Document review & approval
✓ Audit preparation & support
✓ CAPA management
✓ Regulatory submissions

Ad-hoc Consultancy

Tailored regulatory consulting for your specific needs. From technical file reviews to full certification support.

✓ Technical file preparation
✓ Clinical evaluation support
✓ Notified body liaison
✓ Custom training programs

Discuss Your Needs

Quality Management Made Simple