: Industrial control systems configured with predefined control routines.

You likely use Category 4 systems daily. Examples include:

refers to Configurable Software . These are software products that are not used "out of the box." Instead, they are configured by the user or system integrator to meet specific business processes.

Be sure to read on! * What is GAMP? In a nutshell, GAMP is the acronym used to summarize the term “ Good Automated Manufacturing P... DataApex https://www.dataapex.com D193 - Clarity GAMP software categorization certificate - DataApex Configured software is a software package that has been configured to meet user requirements without modification of the vendor's ... Show all Validation Approach Category 4 systems require a comprehensive validation strategy scaled by risk: QbD Group +1 Supplier Assessment: Auditing the vendor's quality system is critical since the user relies on their software development practices. Documentation: Typical deliverables include a User Requirements Specification (URS) , Functional Specification (FS), and Configuration Specification. Testing: Focus is placed on verifying that the configurations correctly meet the business process requirements (OQ/PQ). Standard vendor-provided functions may require less testing than user-specific configurations. LinkedIn +6 Would you like to see a comparison of the

| Feature | Cat 3 (Non-Config) | | Cat 5 (Custom) | | :--- | :--- | :--- | :--- | | Code modified by user? | No | No | Yes | | User sets parameters? | No | Yes | N/A | | Validation effort | Low | Medium | High | | Testing focus | Basic I/O | Configuration testing | Code & logic testing | | Vendor dependency | High | Medium | Low |