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Webinar: Next Gen QMS: Quality, Risk & Compliance Unified Through AI

Configuration vs. Customization

Definition

In the context of EBR and MES software, configuration refers to adjusting a system's built-in settings, workflows, and parameters using tools the vendor provides, without altering the underlying source code. Customization refers to writing new code or modifying the system's core functionality to achieve behavior the platform doesn't natively support.

Benefits

Favoring configuration over customization where possible reduces long-term validation burden, since configured changes are generally easier to re-validate after software updates, while custom code often requires more extensive re-testing and can complicate vendor support and upgrade paths.

Use Case

A pharmaceutical company evaluating an EBR platform needs a site-specific approval workflow. Rather than commissioning custom code, they use the platform's built-in workflow configuration tools to model the required approval sequence, keeping the system on its standard, vendor-supported codebase.

Frequently Asked Questions (FAQ)

  • Customized code changes typically require more rigorous validation and are more vulnerable to breaking during vendor software updates, whereas configuration changes usually stay within the vendor's tested and supported functionality.

  • Not necessarily. Sometimes a genuine business requirement can't be met through configuration alone, but the tradeoff in validation effort and upgrade complexity should be weighed deliberately.

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