Regulatory-Compliant SOP Templates
Production-ready Standard Operating Procedures built for regulatory compliance. Each template includes detailed process flows, mandatory checkpoints, and audit-ready documentation.
GDPR, SOX, HIPAA Compliant
ISO 9001, 27001, 20000 Aligned
Enterprise Audit-Ready
Expert
GDPR Data Breach Response Protocol
GDPR Art. 33/34, ISO 27001
Critical: 72 hours max
Used by 500+ EU companies
Comprehensive 72-hour data breach response procedure compliant with GDPR Article 33 and 34 requirements. Includes breach assessment, notification workflows, and remediation steps.
Information Security10
Process Steps
4
Quality Gates
5
Key Roles
4
Industries
Key Deliverables:
- GDPR Article 33 & 34 compliance checklist
- 72-hour regulatory notification timeline
- Risk severity assessment matrix (High/Medium/Low)
- +4 additional compliance controls
Target Industries:
Financial ServicesHealthcareE-commerceSaaS Platforms
Expert
SOX-Compliant Monthly Financial Close
SOX Sections 302, 404, 906
10 business days
Fortune 500 standard practice
Month-end financial reporting process designed for Sarbanes-Oxley compliance. Includes internal controls, management certifications, and auditable documentation trails.
Finance & Accounting10
Process Steps
4
Quality Gates
5
Key Roles
4
Industries
Key Deliverables:
- SOX 404 internal control testing procedures
- Management certification requirements (SOX 302)
- Auditable journal entry approval workflows
- +4 additional compliance controls
Target Industries:
Public CompaniesBankingInsuranceInvestment Management
Advanced
ISO 20000 IT Change Management
ISO 20000-1, ITIL v4
Variable by change type
Global IT service standard
ITIL-aligned change management process following ISO 20000-1 standards. Covers emergency, standard, and normal changes with risk assessment and rollback procedures.
IT Operations10
Process Steps
4
Quality Gates
4
Key Roles
4
Industries
Key Deliverables:
- ITIL v4 change management framework
- Change Advisory Board (CAB) process
- Risk assessment and impact analysis
- +4 additional compliance controls
Target Industries:
Technology ServicesFinancial ServicesTelecommunicationsManufacturing
Expert
FDA Good Clinical Practice (GCP) Protocol
FDA 21 CFR Part 11, ICH-GCP
Multi-year process
Pharmaceutical industry standard
Clinical trial management following FDA 21 CFR Part 11 and ICH-GCP guidelines. Covers patient safety, data integrity, and regulatory compliance throughout trial lifecycle.
Healthcare & Life Sciences10
Process Steps
4
Quality Gates
4
Key Roles
4
Industries
Key Deliverables:
- ICH-GCP E6(R2) compliance framework
- Electronic data capture (EDC) validation
- Adverse event reporting procedures (21 days)
- +4 additional compliance controls
Target Industries:
PharmaceuticalsBiotechnologyMedical DevicesContract Research Organizations
Advanced
ISO 9001 Supplier Quality Audit
ISO 9001:2015, AS9100
3-5 business days on-site
Global supply chain standard
Comprehensive supplier assessment process aligned with ISO 9001:2015 quality management standards. Includes on-site audits, corrective action plans, and continuous monitoring.
Quality Management10
Process Steps
4
Quality Gates
4
Key Roles
4
Industries
Key Deliverables:
- ISO 9001:2015 clause-by-clause audit checklist
- Risk-based thinking assessment methodology
- Corrective Action Preventive Action (CAPA) planning
- +4 additional compliance controls
Target Industries:
AutomotiveAerospaceMedical DevicesManufacturing
Expert
HIPAA Breach Notification Procedure
HIPAA Breach Notification Rule
60 days maximum timeline
Required for all HIPAA entities
Healthcare data breach response following HHS HIPAA Breach Notification Rule. Covers risk assessment, patient notification, and regulatory reporting requirements.
Healthcare Compliance10
Process Steps
4
Quality Gates
4
Key Roles
4
Industries
Key Deliverables:
- Four-factor HIPAA risk assessment methodology
- 60-day patient notification timeline compliance
- HHS breach reporting portal submission
- +4 additional compliance controls
Target Industries:
HospitalsClinicsHealth PlansHealthcare Clearinghouses