System validation for accuracy, reliability, and consistent intended performance.
Assyro control
Validation lifecycle support with requirements traceability and test evidence aligned to intended use.
Evidence examples
Validation plans, execution results, traceability matrix, and validation summary reports.
11.10(b)
Implemented in platform controls
Requirement
Accurate and complete copies of records in human-readable and electronic form.
Assyro control
Controlled record export and rendering pathways for inspection-ready outputs.
Evidence examples
Export SOPs, sample electronic outputs, and human-readable record print views.
11.10(c)
Implemented in platform controls
Requirement
Protection and retrieval of records through retention periods.
Assyro control
Retention-aware storage model, backup controls, and recovery procedures for required records.
Evidence examples
Retention policy, backup logs, and restore test reports.
11.10(d)
Implemented in platform controls
Requirement
Limit system access to authorized individuals.
Assyro control
Role-based access controls, least-privilege authorization, and account lifecycle controls.
Evidence examples
RBAC matrix, provisioning/deprovisioning logs, and access review records.
11.10(e)
Implemented in platform controls
Requirement
Secure, computer-generated, time-stamped audit trails for record create/modify/delete actions.
Assyro control
Auditability model with time-stamped action history and change visibility for regulated records.
Evidence examples
Audit trail extracts, review SOP, and retention alignment evidence.
11.10(f)-(h)
Implemented in platform controls
Requirement
Operational checks, authority checks, and appropriate device/source checks.
Assyro control
Workflow sequencing, permission gates, and source validity controls for system operations.
Evidence examples
Workflow specifications, authorization tests, and control configuration records.
11.10(i)-(k)
Implemented in platform controls
Requirement
Qualified personnel, accountability policies, and controlled system documentation.
Assyro control
Training governance, electronic signature accountability policy, and controlled documentation lifecycle.
Evidence examples
Training records, policy acknowledgments, revision history, and change-control documentation.
11.30
Implemented in platform controls
Requirement
Open-system controls with additional authenticity/integrity/confidentiality measures.
Assyro control
Transport and integration security controls, with additional safeguards for external exchange contexts.
Evidence examples
Security architecture records, encryption standards, and interface control evidence.
11.50, 11.70
Implemented in platform controls
Requirement
Signature manifestations and secure signature-to-record linkage.
Assyro control
Signed records include signer identity, timestamp, and meaning, bound to the underlying record context.
Evidence examples
Signed record examples and linkage control test evidence.
11.100, 11.200, 11.300
Implemented in platform controls
Requirement
Unique e-signatures, identity verification, multi-component signing controls, and credential safeguards.
Assyro control
Unique user identity model with controlled credential practices and signature workflow safeguards.
Evidence examples
Identity and credential policy records, auth controls, and signature process artifacts.
GxP Alignment
Assyro is designed to support GxP-regulated workflows (including GMP, GLP, and GCP contexts) through validation support, auditability, access controls, controlled change processes, and record lifecycle controls.
Scope and Responsibility
Assyro provides platform controls mapped to FDA Part 11 requirements. Final compliance outcomes depend on customer configuration, SOPs, validation execution, and quality system governance in production use.
For legal and security materials, see Legal and Security.
