Black Box Penetration Test for an Electronic Quality Management System (eQMS)
Budget: $250 – $750 USD
1. Objective
The purpose of this penetration test is to assess the security posture of the Electronic Quality Management System (eQMS) from an external attacker's perspective, without prior knowledge of internal architecture, source code, or credentials. The goal is to identify security vulnerabilities that could compromise confidentiality, integrity, and availability, ensuring compliance with industry regulations and security best practices.
2. Scope of Testing
The penetration test will cover the following components:
Application Layer
- Web Application – The main interface of the eQMS, including authentication mechanisms, user roles, input validation, file uploads, and overall application logic.
- APIs – Any externally exposed endpoints for integrations, data exchange, or system automation.
- Authentication & Authorization – Role-based access control (RBAC), session management, password policies, and multi-factor authentication (MFA).
- Data Security – Protection of sensitive information, including compliance documents, audit logs, and quality reports
Infrastructure Layer
- Network Security – Public-facing endpoints, cloud services, firewall configurations, and access control policies.
- Server Security – If applicable, assessment of underlying operating systems, misconfigurations, and exposure to known vulnerabilities.
3. Methodology
The test will adhere to industry best practices, including:
- OWASP Top 10 – Standard framework for web application security.
- NIST SP 800-115 – Technical guidelines for penetration testing.
- MITRE ATT&CK Framework – Adversary tactics and techniques.
- SANS CWE – Common software weaknesses and mitigations.
The penetration test will follow these stages:
1. Reconnaissance – Identifying public information about the eQMS.
2. Scanning & Enumeration – Mapping the attack surface.
3. Exploitation – Attempting to exploit security flaws.
4. Post-Exploitation – Evaluating the impact of successful attacks.
5. Reporting & Recommendations – Delivering a structured report with findings and remediations.
4. Compliance & Regulatory Considerations
The penetration test will be conducted in alignment with:
Regulatory Standards:
- ISO 27001 – Information Security Management compliance.
- FDA 21 CFR Part 11 – Compliance for electronic records and electronic signatures (if applicable).
- GDPR – Protection of personal data within the system (if applicable).
- HIPAA – If the eQMS handles healthcare-related quality management data.
Security Best Practices:
- CIS Benchmarks – Secure configurations for cloud and server infrastructure.
- NIST Cybersecurity Framework – Guidelines for risk management and mitigation.
5. Testing Constraints & Assumptions
- Testing will be non-destructive and will not impact system availability.
- No credentials or prior internal knowledge will be provided.
- Testing will be conducted only on approved environments (e.g., staging or dedicated test environments).
- Production testing, if required, will be scheduled to minimize disruptions.
6. Deliverables
- Executive Summary – High-level overview of findings for stakeholders.
- Technical Report – In-depth vulnerabilities, risk assessments, and remediation steps.
- Proof of Concepts (PoC) – Demonstrations of successfully exploited vulnerabilities (where applicable).
- Compliance Recommendations – Mapping findings to regulatory standards and best practices.
7. Timeline & Effort
- Estimated testing duration: 2 weeks
- Report delivery: 3 days after test completion
The purpose of this penetration test is to assess the security posture of the Electronic Quality Management System (eQMS) from an external attacker's perspective, without prior knowledge of internal architecture, source code, or credentials. The goal is to identify security vulnerabilities that could compromise confidentiality, integrity, and availability, ensuring compliance with industry regulations and security best practices.
2. Scope of Testing
The penetration test will cover the following components:
Application Layer
- Web Application – The main interface of the eQMS, including authentication mechanisms, user roles, input validation, file uploads, and overall application logic.
- APIs – Any externally exposed endpoints for integrations, data exchange, or system automation.
- Authentication & Authorization – Role-based access control (RBAC), session management, password policies, and multi-factor authentication (MFA).
- Data Security – Protection of sensitive information, including compliance documents, audit logs, and quality reports
Infrastructure Layer
- Network Security – Public-facing endpoints, cloud services, firewall configurations, and access control policies.
- Server Security – If applicable, assessment of underlying operating systems, misconfigurations, and exposure to known vulnerabilities.
3. Methodology
The test will adhere to industry best practices, including:
- OWASP Top 10 – Standard framework for web application security.
- NIST SP 800-115 – Technical guidelines for penetration testing.
- MITRE ATT&CK Framework – Adversary tactics and techniques.
- SANS CWE – Common software weaknesses and mitigations.
The penetration test will follow these stages:
1. Reconnaissance – Identifying public information about the eQMS.
2. Scanning & Enumeration – Mapping the attack surface.
3. Exploitation – Attempting to exploit security flaws.
4. Post-Exploitation – Evaluating the impact of successful attacks.
5. Reporting & Recommendations – Delivering a structured report with findings and remediations.
4. Compliance & Regulatory Considerations
The penetration test will be conducted in alignment with:
Regulatory Standards:
- ISO 27001 – Information Security Management compliance.
- FDA 21 CFR Part 11 – Compliance for electronic records and electronic signatures (if applicable).
- GDPR – Protection of personal data within the system (if applicable).
- HIPAA – If the eQMS handles healthcare-related quality management data.
Security Best Practices:
- CIS Benchmarks – Secure configurations for cloud and server infrastructure.
- NIST Cybersecurity Framework – Guidelines for risk management and mitigation.
5. Testing Constraints & Assumptions
- Testing will be non-destructive and will not impact system availability.
- No credentials or prior internal knowledge will be provided.
- Testing will be conducted only on approved environments (e.g., staging or dedicated test environments).
- Production testing, if required, will be scheduled to minimize disruptions.
6. Deliverables
- Executive Summary – High-level overview of findings for stakeholders.
- Technical Report – In-depth vulnerabilities, risk assessments, and remediation steps.
- Proof of Concepts (PoC) – Demonstrations of successfully exploited vulnerabilities (where applicable).
- Compliance Recommendations – Mapping findings to regulatory standards and best practices.
7. Timeline & Effort
- Estimated testing duration: 2 weeks
- Report delivery: 3 days after test completion