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AI-Enabled, Configurable Workflows for Quality, Manufacturing and Post-Market Surveillance.
Explore Cytodyme in action
Keep the right revision in everyone's hands.
Quality Management Suite · Document Control
Keep the right revision in everyone's hands.
Move controlled documents through review and approval. Keep effective versions, revision history, and training assignments connected in your QMS.
Explore Document ControlBuilt for regulated
life sciences
FDA 21 CFR Part 11 Compliant
Supports MDR & IVDR workflows
End-to-end audit trails
Manage quality, manufacturing, and post-market work in a system that keeps your records and processes connected.
Quality Management
Set up your QMS around the processes your team already uses, with records and approvals tied to the work they belong to.
Manufacturing
Keep batch records, calculations, and certificates tied to the same manufacturing data, with deviations able to move into the quality system when they need to.
Post-Market Surveillance
Bring complaint intake and literature surveillance into the same system, so the information is there when you need it for review, investigation, and reporting.
Product Highlight: Certificate of Analysis
Give your team more time for quality work. Cytodyme automatically populates certificates from your test records, with source references to verify each result before approval.
Stay in Control.
AI takes on repetitive preparation while your team verifies the information, makes corrections, and completes review and approval.
Keep Your Docs Connected.
Related quality records stay linked through investigation, action, and review. Follow the history and supporting evidence behind an issue without chasing information across systems.
Configured Around Your Processes.
Shape workflows around your existing processes, including what information is required and how work moves through review and approval.
Continuously Meet & Maintain Compliance Standards
Receive guidance, change signals, and structured outputs to help teams stay aligned with standards including:
Maximum Security
Cytodyme meets industry expectations for security, data integrity, and system controls, with capabilities aligned to standards such as FDA 21 CFR Part 11, ISO 13485, ICH Q10, and 21 CFR Part 820
Validation-ready Infrastructure
Built to support validation activities for quality and post-market workflows, with system controls aligned to FDA 21 CFR Part 11, ISO 13485, MDR, and IVDR expectations. Structured records, traceability, version control, and good documentation practices support inspections and audits.
Auditability & Access Control
Every action is logged, time-stamped, and attributable to a user. Role-based access controls enforce least-privilege permissions, while complete version history, approvals, and audit trails support inspection readiness and internal governance.
Security by design
Encryption at rest and in transit, OAuth 2.0, and two-factor authentication. Customer data is isolated, never used beyond its intended purpose, and AI features do not train on customer content. Supports strict data ownership and separation requirements.
Questions?
Who is Cytodyme built for?
Cytodyme is built for life science teams managing quality, manufacturing, and post-market work. It connects documents, quality events, training, equipment, design records, batch records, calculations, certificates, complaints, and literature surveillance in one platform.
Which workflows does Cytodyme support?
The platform spans quality management, manufacturing, and post-market surveillance. Teams can manage controlled records and approvals, use validated calculations, automate Certificate of Analysis preparation, and complete forms and reports from supporting documents. Explore the suite pages to see the workflows in each area.
How does Cytodyme fit our existing processes?
Configure workflows around your procedures, required information, and review steps. Start with the records and templates your team already uses, and connect related information so people can follow the work through completion and approval.
How does Cytodyme support controlled work?
Structured workflows, version history, role-based access, review, and approval help teams control their records. Audit trails and source references preserve the information behind the work, so reviewers can check the evidence and document their decisions.
Is there a human-in-the-loop review process?
Yes. AI helps prepare information and draft outputs for your team to check. Your team verifies the sources, makes corrections, and completes the review and approval steps required by your process.
How does Cytodyme handle data security and confidentiality?
Data security is a core priority. Cytodyme uses secure infrastructure, access controls, and role-based permissions to protect sensitive information. Customer data is never used to train models, and all workflows are designed with confidentiality in mind.
How long does it take to get started?
Setup depends on the solutions you choose, the records you bring, and your configuration and validation requirements. We work with your team to agree the scope and onboarding plan.
How does Cytodyme scale as our work grows?
Add workflows across the product suites as your team’s needs grow. Connected records and reusable templates help teams handle more recurring work while preserving review, ownership, and traceability.