Athyrion centralizes document control, training, CAPA, deviations, change control, risk, audits, and supplier management in a single system of record — so your team always knows what needs attention and can prove it later.
Real-time visibility. Controlled workflows. Traceable records.
10 questions • Immediate QMS score • Prioritized recommendations
Quality System Visibility
No more searching through spreadsheets, shared drives, and email threads. Athyrion brings overdue actions, upcoming deadlines, and system status into one place.
Open CAPAs, deviations, changes, and tasks — with what's due and what's late.
Track completion and overdue training assignments across your team.
Active and upcoming audits, supplier status, and readiness scoring at a glance.
Open risks, ALARP items, and controlled changes across the quality system.
One Platform
Instead of managing document control, training, and corrective actions across spreadsheets, shared drives, and email, Athyrion brings them into a single, controlled system — so every record, task, and approval lives in one place.
Platform Capabilities
Centralized control of controlled documents, revisions, and approvals.
Assign, track, and evidence training requirements across your team.
Route tasks and approvals to the right owners to reduce manual follow-up.
Track corrective actions and quality events from finding to closure.
Keep records organized and accessible so you're always ready for review.
Track supplier qualifications, risk classification, and audit oversight.
See status and ownership across your quality system at a glance.
Maintain a clear, traceable record of every review and approval.
Supplier Management
Qualify suppliers, classify risk, and track certifications, audits, and quality actions in the same system as the rest of your QMS — with change control tied directly to supplier records.
Approval status, risk level, and audit frequency in one profile.
Open quality actions, certifications, and audit history at a glance.
Risk & Traceability
Score initial and residual risk, route changes through controlled evaluation and approval, and rely on an immutable audit trail that links every record back to the decisions behind it.
Free Interactive Tool
Answer 10 questions to identify potential QMS gaps and get an immediate score with prioritized recommendations — based on the framework you select.
Your QMS Score
Developing
Framework: ISO 9001
Document control needs stronger revision tracking
CAPA effectiveness checks are inconsistent
Internal audit program is on schedule
Built to close the gap
Athyrion was built to close the gap between generic consulting, complex enterprise QMS software, and the practical support growing organizations actually need. We help teams build usable procedures, prepare for audits, organize quality records, and establish systems that can be maintained long term.
What We Help With
Support for FDA-regulated and GxP environments, including quality system structure, documentation, training, and audit readiness.
Create clear, controlled procedures, SOPs, forms, templates, and records that are practical for daily use.
Practical quality system support for laboratories, blood banks, and regulated testing environments working under CAP, CLIA, USP, or related requirements.
Risk-based audit planning, checklist development, audit execution support, finding documentation, and audit response preparation.
Quality management system development, gap assessments, procedure development, certification readiness, and corrective action support.
Support for supplier evaluation, qualification records, risk-based supplier controls, and supplier audit readiness.
Root cause analysis, corrective action planning, effectiveness checks, and closure support.
Our Approach
Understand your current quality system, records, risks, and audit exposure.
Identify the most important gaps and focus on the actions that reduce risk fastest.
Develop practical procedures, forms, records, training, and workflows your team can maintain.
Assign ownership, roll out processes, train personnel, and establish evidence of execution.
Support internal audits, certification readiness, accreditation readiness, customer audits, and inspection preparation.
Use findings, metrics, CAPAs, and management review inputs to strengthen the system over time.
Why Athyrion
Work directly with experienced consultants who understand your industry and challenges.
Practical solutions based on years of implementing and improving quality systems.
Actionable, right-sized solutions that fit your organization and deliver measurable results.
Support tailored for quality, lab, and compliance professionals in regulated environments.
Resources & Insights
ISO 9001
A practical breakdown of ISO 9001 certification costs, including registrar fees, implementation support, internal time, audits, and ongoing certification expenses.
ISO 9001
A practical look at what a small company actually needs to build an ISO 9001 quality management system — without creating unnecessary bureaucracy.
Free Tool
Answer 10 questions to identify potential QMS gaps and get an immediate score with prioritized recommendations.
