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Compliance Auditing And Monitoring Policy
"I need a Compliance Auditing and Monitoring Policy for our medium-sized pharmaceutical manufacturing company in Jakarta, with specific focus on GMP compliance and data integrity requirements, to be implemented by March 2025."
1. Purpose and Scope: Defines the objective of the policy and its application scope within the organization
2. Regulatory Framework: Overview of applicable Indonesian laws and regulations that the policy addresses
3. Definitions: Detailed definitions of technical terms, regulatory references, and key concepts used throughout the policy
4. Roles and Responsibilities: Defines responsibilities of key stakeholders including board, management, compliance team, and employees
5. Compliance Risk Assessment: Framework for identifying, assessing, and prioritizing compliance risks
6. Monitoring Program Structure: Details of the monitoring program including frequency, methods, and coverage areas
7. Audit Procedures: Specific procedures for conducting compliance audits, including methodology and documentation requirements
8. Documentation and Record Keeping: Requirements for maintaining audit trails, evidence, and compliance records
9. Reporting Requirements: Procedures for internal and regulatory reporting, including escalation protocols
10. Corrective Actions: Process for addressing identified compliance issues and tracking remediation efforts
11. Data Protection and Confidentiality: Protocols for handling sensitive information during audits and monitoring activities
12. Training and Communication: Requirements for staff training on compliance monitoring and audit procedures
13. Policy Review and Updates: Process for periodic review and updating of the policy
1. Industry-Specific Compliance Requirements: Additional requirements for specific industries (e.g., financial services, healthcare)
2. International Compliance Standards: Applicable for organizations operating internationally or following global standards
3. Technology and Systems: Detailed procedures for using compliance monitoring and audit software
4. Remote Auditing Procedures: Specific procedures for conducting remote audits when physical presence is not possible
5. Third-Party Audit Management: Procedures for managing external auditors and third-party compliance reviews
6. Business Continuity Considerations: Procedures for maintaining compliance monitoring during business disruptions
1. Compliance Risk Assessment Matrix: Template for assessing and scoring various compliance risks
2. Audit Program Template: Standard template for creating annual audit programs
3. Monitoring Checklist: Detailed checklist for regular compliance monitoring activities
4. Report Templates: Standard templates for various compliance reports and findings
5. Corrective Action Plan Template: Template for documenting and tracking remediation efforts
6. Regulatory Reporting Calendar: Schedule of regulatory reporting deadlines and requirements
7. Sample Audit Documentation Forms: Standardized forms for documenting audit activities and findings
8. Escalation Matrix: Details of escalation procedures and contact information for various compliance issues
Authors
Audit Evidence
Audit Finding
Audit Program
Audit Trail
Compliance
Compliance Monitoring
Compliance Risk
Corrective Action
Control Environment
Data Protection Officer
Documentation
External Audit
Internal Audit
Internal Control
Material Breach
Monitoring Activities
Non-compliance
OJK
Preventive Controls
Random Sampling
Regulatory Requirements
Remote Audit
Risk Assessment
Risk Rating
Root Cause Analysis
Sampling Methodology
Scope of Audit
Senior Management
Significant Finding
Standard Operating Procedure
Substantial Compliance
System of Internal Controls
Testing Procedures
Third-Party Auditor
Whistleblower
Working Papers
Compliance Committee
Control Testing
Detective Controls
Internal Control Framework
Key Performance Indicator (KPI)
Key Risk Indicator (KRI)
Material Weakness
Monitoring Plan
Remediation Plan
Risk Tolerance
Sampling Risk
Scope and Application
Governance Structure
Risk Assessment
Compliance Monitoring
Audit Planning
Documentation Requirements
Reporting Obligations
Confidentiality
Data Protection
Employee Rights
Training Requirements
Quality Assurance
Record Retention
Corrective Actions
Escalation Procedures
External Reporting
Technology and Systems
Resource Allocation
Methodology
Independence and Objectivity
Access Rights
Communication Protocols
Regulatory Reporting
Evidence Collection
Conflict of Interest
Professional Standards
Review and Updates
Whistleblower Protection
Business Continuity
Third-Party Management
Sanctions and Enforcement
Banking and Financial Services
Insurance
Healthcare
Manufacturing
Mining and Natural Resources
Technology and Communications
Retail and Consumer Goods
Transportation and Logistics
Energy and Utilities
Construction and Real Estate
Pharmaceuticals
Education
Professional Services
Legal
Compliance
Internal Audit
Risk Management
Finance
Operations
Human Resources
Information Technology
Quality Assurance
Corporate Governance
Regulatory Affairs
Ethics
Information Security
Chief Compliance Officer
Head of Internal Audit
Risk Manager
Compliance Manager
Internal Auditor
Legal Counsel
Chief Executive Officer
Chief Financial Officer
Board Director
Department Head
Quality Assurance Manager
Operations Manager
Human Resources Director
Information Security Officer
Regulatory Affairs Manager
Find the exact document you need
Compliance Auditing And Monitoring Policy
An internal policy document establishing compliance monitoring and auditing procedures aligned with Indonesian regulatory requirements and best practices.
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