aChiral Cobalt - Intelligent Document 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 — our document management system adapts to your industry with the compliance tools you need.

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

Clinical Trials

New

Manage your entire clinical documentation ecosystem. From eTMF to eISF, keep every trial document organized, compliant, and audit-ready across sponsors, CROs, and investigator sites.

eTMF with 8-zone ICH taxonomy
eISF portals for investigator sites
Expected document lists & QC reviews
Study lifecycle & milestone tracking

GDPR & Data Privacy

Built-in GDPR compliance — not a bolt-on. Manage processing activities, handle data subject requests within legal timelines, and demonstrate accountability to supervisory authorities.

ROPA (Record of Processing Activities)
DSAR workflows & breach management
DPIA with risk scoring & approval
Consent & processor agreement tracking

Document-Centric DMS

Not just storage — a complete document lifecycle platform. Built-in Word-like editor, track changes, annotations, controlled distribution, and DocuSign-like signature collection.

Word-like editor with TOC & track changes
Signature collection & e-signatures
Secure data rooms & external sharing
Watermarks, retention & legal holds

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

Learn More

WHY ACHIRAL COBALT

Enterprise Documents, Startup Simplicity

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

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

One Platform, Every Document

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

Document Management & Control

Document Control

Complete document lifecycle management: version control, multi-step approval workflows, controlled distribution, folder hierarchy, retention policies, and automated review reminders. From draft to obsolete, every document is traceable.

Word-Like Editor

Rich text editor with headers/footers, table of contents, page breaks, table styles, track changes, and Word import/export.

Electronic Signatures

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

Full-Text Search

Meilisearch-powered instant search across all documents, templates, and records with typo tolerance and filters.

Annotations & Comments

Contextual document annotations, threaded comments, inline discussions, and collaborative review workflows.

PDF Generation & Signing

Generate compliant PDFs with watermarks, digital signatures, and controlled distribution for regulated documents.

Collaboration & Workflow

Workflow & Approvals

Configurable multi-step approval workflows with parallel/sequential routing, delegation, and escalation.

Discussions & Tasks

Entity-linked discussions, task assignments with priorities and deadlines, and @mention notifications.

External Sharing

Share documents securely with external parties via OTP verification, with view, annotate, and edit permission levels.

Secure Data Rooms

Dedicated virtual data rooms for audits, due diligence, and regulatory submissions with Q&A and activity tracking.

Training Management

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

New

eTMF (Trial Master File)

ICH-compliant electronic Trial Master File with 8-zone TMF taxonomy, expected document lists, study lifecycle management, QC reviews, and audit-ready completeness tracking.

New

eISF (Investigator Site File)

Electronic Investigator Site File portals for clinical trial sites. Manage site-level documents, monitor submissions, and ensure completeness per ICH E6(R2) guidelines.

New

Document Distribution

Controlled document distribution lists with versioned deliveries, electronic acknowledgment, signer tracking, and complete access audit trails.

Quality Management (QMS)

CAPA Management

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

Change Control

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

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.

Audit Management

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

Regulatory & Compliance

New

Compliance Program

15+ regulatory framework templates (ISO 9001, 13485, 14971, EU MDR, FDA) with planning, tracking, and scoring.

GDPR & Privacy

Comprehensive GDPR compliance module: Record of Processing Activities (ROPA), Data Subject Access Requests with automated timelines, consent management with withdrawal tracking, breach incident management, Data Protection Impact Assessments (DPIA), and processor agreement tracking.

Gap Analysis

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

Supplier Management

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

Customer Management

Customer portals, document sharing, order tracking, and relationship management for regulated products.

Reports & Analytics

Custom report builder, analytics dashboards, and export to CSV, Excel, and PDF for management review.

Product Lifecycle & Device Management

Software Lifecycle

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

Post-Market Surveillance

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

Clinical Evaluations

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

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.

Product Management

Product families, Bill of Materials (BOM), design history files (DHF), and product lifecycle tracking.

Business & Project Management

Project Management

Gantt charts, resource allocation, capacity planning, deliverables, milestones, and cross-functional project tracking.

Meeting Management

Meeting scheduling, agendas, minutes, action items, and attendee tracking for quality and management reviews.

Coming Soon

Quotations & Budgeting

Create and manage project quotations, budgets, and cost tracking for regulated product development.

Coming Soon

Resource Planning

Capacity planning, resource allocation across projects, workload balancing, and utilization dashboards.

Dashboard & My Tasks

Personalized dashboard with pending approvals, assigned tasks, recent activity, and notification center.

API & Integrations

RESTful API with 100% endpoint coverage, API token management, webhooks, and third-party integration support.

PRICING

Accessible for Everyone

Professional document management with compliance tools shouldn't be reserved for big corporations. Our pricing is designed to be accessible for startups and SMEs.

⚡ Special Launch Offer

Start Your Quality Journey Today

Contact us for a personalized quote based on your organization size and needs. We offer flexible plans starting from just a few hundred euros per month.

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No Setup Fees

Get started immediately

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Free Trial

30 days, no credit card

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Cancel Anytime

No long-term contracts

Get Your Custom Quote

Ready to Get Started?

Have questions or ready to transform your quality management? Fill out the form and our team will get back to you within 24 hours.

Email Us

info@achiral.it

Response Time

We typically respond within 24 hours

Free Consultation

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Document Management Built for Compliance