cGMP & Regulated Applications
Built for regulated environments, from development through cGMP manufacturing.
Symphony was designed from the ground up to support cGMP use and 21 CFR Part 11 requirements. Our Validation Package adds the configuration, documentation, and support to qualify and validate a specific deployment.
Access control
Role-based access with fine-grained permissions and authentication for users and automations.
Version control
Track every version of your models and their deployments.
Approvals & electronic signatures
Define approval workflows with electronic signatures and full traceability.
Audit trails
Immutable audit logs of all user actions and system events.
Electronic records
Secure storage of records that are complete, accurate, and readily retrievable.
Data integrity
Model fingerprinting and validated signatures ensure no model changes go unnoticed.
Included in Symphony
Always included
- Model lifecycle & governance
- Versioning & approvals
- Traceability & deployment records
- Audit trails & logging
- Access control & permissions
- Secure architecture
- APIs, SDKs & integrations
Additional Package
cGMP Deployment & Validation Package
Scoped directly with our team for your deployment. Available starting January.
- Controlled, cGMP-oriented configuration
- Installation qualification (IQ)
- Operational qualification (OQ)
- Validation documentation package
- Implementation & validation support
- Ongoing support to maintain a validated state
We work with you every step of the way
Plan
Understand your use case, environment, and regulatory requirements.
Configure
Apply the controlled configuration and settings you require.
Integrate
Connect Symphony to your equipment, systems, and data sources.
Qualify / Validate
Use our guidance and documentation to support your qualification.
Go live
Deploy with confidence and start running models in a controlled state.
Maintain
We help you manage changes and keep your deployment current.
Ready to talk validation?
Tell us about your regulatory requirements and we'll walk you through the cGMP Deployment & Validation Package.