Data Flow Mapping & Data Flow Risk Assessments

In today’s digital landscape, data security and regulatory compliance are critical priorities. To protect sensitive information and adhere to industry regulations, organizations must clearly understand how data moves through their systems and proactively identify potential risks. Data Flow Mapping (DFM) and Data Flow/Integrity Risk Assessments are essential tools in achieving compliance with data integrity standards.

These practices help organizations trace data pathways, uncover vulnerabilities, and ensure the integrity of their data in alignment with regulatory frameworks such as FDA 21 CFR Part 11, Annex 11, and GDPR.

Data Flow Map:

A Data Flow Map illustrates how information moves within a system, detailing the processes involved in data handling—from how it is collected and processed to how it is stored and transferred between various entities such as users, databases, and external systems.

How to Perform Data Flow Mapping (DFM):

1. Identify Data Sources

• • Pinpoint where data originates (e.g., customer forms, IoT devices, applications).
  • Include both structured data (e.g., databases) and unstructured data (e.g., emails, PDFs).

2. Track Data Movement

• • Map how data flows across systems, departments, and third-party services.
  • Document transmission channels such as email, cloud storage, and network transfers.

3. Categorize Data

• • Classify data based on sensitivity levels (e.g., public, confidential, restricted).
  • Define data types, including Personally Identifiable Information (PII), healthcare data, etc.

4. Identify Storage Locations

• • Determine where data is stored (e.g., on-premises servers, cloud platforms, local devices).
  • Evaluate the security controls in place for each storage location.

5. Define Data Processing Activities

• • Identify who accesses and processes the data, and for what purposes.
  • Ensure alignment with internal privacy policies and external legal requirements.

6. Assess Data Sharing & External Transfers

• • Track data shared with third parties, vendors, or external entities.
  • Confirm that appropriate contracts and Data Protection Agreements (DPAs) are in place.

7. Visualize the Data Flow

• • Create a visual representation (e.g., flowchart or diagram) of the data lifecycle.
  • Use tools like Microsoft Visio or equivalent diagramming software.

What to Include in a Data Flow Map?

Data Flow Map Risk Assessment:

A Data Flow Map Risk Assessment is a systematic approach used to identify, evaluate and mitigate potential risks associated with the movement of data within a system. Its purpose is to proactively safeguard data confidentiality, integrity, and availability, while ensuring compliance with relevant regulatory requirements.

Steps to Perform a Data Risk Assessment (DRA):

1. Identify Critical Data and risks

• Prioritize high-risk data.
• List potential risks (Data breaches, Hardware failures, Human error)

2. Assess Data Access & Permissions
   • Determine who has access to critical data.
   • Implement Role-Based Access Control (RBAC).

1. Evaluate Security Controls

• Check encryption, multi-factor authentication (MFA), and firewalls.

1. Assess Data Transfer Risks

• Identify risks when data is moved between systems, cloud storage, or external system.
• Ensure secure protocols (VPN, data masking) are in place.

5. Assess Risk Impact

• Determine the likelihood and severity of each risk.
  • Use a scoring method (High, Medium and Low).

 

6. Mitigation Planning
   • Develop and document strategies to address each risk.
   • Assign responsibilities and establish timelines.

1. Monitor and Review

• • Continuously monitor risks and validate the effectiveness of mitigations.

What to Include in a Data Risk Assessment Report?

 

Importance of Data Flow Mapping & Risk Assessments

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