FDA Compliance

Solution & Benefits Lifecycle Related Regulations

FDA Compliance Lifecycle

The FDA compliance lifecycle includes the following steps, all automatically enacted by the ProcessGene™ GRC Software Suite:

Lifecycle step FDA activity
FDA context establishment
  1. Definition of FDA compliance related business processes
  2. Delineation of process diagrams (optional)
  3. Definition of assets within the FDA scope
  4. Standardization and documentation of FDA regulations, policies and procedures
Risk identification
  1. Risk description, identification of risk stakeholders
  2. Risk classification and determination of heat-maps
  3. Risk assessment and measurement
  4. Determination of Key Risk Indicators (KRIs)
  5. Risk tolerance determination
Control determination
  1. Definition of controls to mitigate identified FDA risks
  2. Assignment of FDA control owners
  3. Scheduling and monitoring FDA control execution
  4. Assessment of residual risk levels
Requirement management
  1. Requirement definition
  2. Automated requirement workflow management
  3. Requirement fulfillment monitoring
FDA audit and remediation
  1. Definition and scheduling of FDA audit plans
  2. Definition of mechanisms for testing ongoing FDA compliance
  3. Collection, analysis and storage of FDA audit results
  4. Remediation plan definition, execution and follow-up
FDA related incident management
  1. Incident recording
  2. FDA related incident handling (using scheduled workflows)
  3. FDA related incident analysis and reporting
  4. Incident monitoring and follow-up
FDA certification
  1. Hierarchal FDA certification process determination
  2. Establishment of an automated FDA certification process
  3. Monitoring and reporting FDA certification status
  4. Archiving FDA certification history
Multi-Org management
  1. Determination of a global FDA compliance baseline with mandatory components
  2. Establishing a workflow for examining local (subsidiary) variants
  3. Enforcement of enterprise guidelines, regulations and frameworks within subsidiaries
  4. Control FDA compliance level both locally (per subsidiary) and globally from a central HQ cockpit

The ProcessGene™ FDA Software Users

The ProcessGene™ FDA compliance software provides value to the following users:
  1. C-level management (CEO, CFO, CIO, CRO, COO)
  2. Board of directors
  3. Compliance officers
  4. Internal auditors
  5. FDA compliance managers



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