White Paper: Getting Requirements Right: A Practical Framework for URS and FRS Construction in GMP-Regulated Electronic Systems

$25.00

This white paper provides a practical, GAMP 5-aligned framework for defining, gathering, and managing User Requirements Specifications (URS) and Functional Requirements Specifications (FRS) for computerized systems in GMP manufacturing. It outlines how URS and FRS fit into the GAMP lifecycle, offers best practices for structuring requirement documents, and details methods for collecting, organizing, and documenting stakeholder input. Finally, it addresses review and approval processes, ensuring requirements are complete, testable, traceable, and regulatory inspection-ready.

This white paper provides a practical, GAMP 5-aligned framework for defining, gathering, and managing User Requirements Specifications (URS) and Functional Requirements Specifications (FRS) for computerized systems in GMP manufacturing. It outlines how URS and FRS fit into the GAMP lifecycle, offers best practices for structuring requirement documents, and details methods for collecting, organizing, and documenting stakeholder input. Finally, it addresses review and approval processes, ensuring requirements are complete, testable, traceable, and regulatory inspection-ready.