Compliance

Requirement: 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.