“To classify software into GxP and Non-GxP categories, it is required
assess its impact on regulated processes and data”
Impact
GxP Non-GxP
Product Patient Data Regulatory Business
Quality Safety Integrity Compliance operations
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GxP Category Non-GxP Category
Used in regulated industries like pharmaceuticals, Used for general business operations and does not
medical devices, and biotechnology etc. directly impact regulated processes.
• Direct impact on product quality, patient safety, • No or indirect impact GxP processes, primarily
data Integrity and regulatory compliance. supports business functions like finance, HR, etc.
Characteristic: Characteristic:
• Controls manufacturing processes • May support GxP systems, but is not directly involved
• Records and analyzes critical data in critical processes
• Generates documentation required for regulatory • May store or process GxP data, but is not critical to
compliance data integrity
Subject to regulatory oversight:
• Adheres to industry standards like FDA 21 CFR Part
11, EU Annex 11 etc.
Requires validation and verification to ensure Not subject to the same level of regulatory
accuracy and reliability oversight as GxP software
Example: Example:
• Lab. Information Management Systems (LIMS) • Enterprise Resource Planning (ERP) Systems
• Manufacturing Execution Systems (MES) • HR Management (HRM) Systems
• Quality Management Systems (QMS) • Productivity Software (e.g., MS Office)
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