GxP Validation Protocol Template for Business Central

By Thomas Brünger, Managing Partner

gxp · validation · templateJuly 19, 2026

A GxP validation protocol template gives a regulated manufacturer the structure of a validation package for Microsoft Dynamics 365 Business Central - the documents, their order, and how they trace to each other. It is a starting point to adapt by risk and execute, not a finished protocol: the template does not make a system validated, executing an adapted version against real evidence does.

What the template covers

A defensible validation package for Business Central has a consistent shape:

  • Validation Plan - scope, GxP risk assessment, roles, and the deliverables list.
  • User Requirements Specification (URS) - functional, data-integrity, security, and regulatory requirements, approved by QA.
  • Installation Qualification (IQ) - the system is installed and configured as specified.
  • Operational Qualification (OQ) - each requirement is tested and behaves as intended.
  • Performance Qualification (PQ) - the system performs under real process conditions.
  • Traceability matrix - every requirement maps to the test that proves it.
  • Deviation log - every test deviation assessed and closed before release.
  • Validation Summary Report (VSR) - the QA-approved conclusion that the system is fit for intended use.

How to use it

Adapt the depth to a risk assessment (CSA under GAMP 5): the GxP-critical functions - audit trail, electronic signatures, batch release - warrant full rigour; low-risk functions warrant less, documented. Then execute the protocols with real evidence and retain the records. See GxP validation for Business Central for the regulatory framework and computer system validation step by step for the lifecycle.

A short architecture governance review can confirm the protocol design and traceability meet the standard before execution.

Frequently asked questions

What does a GxP validation protocol package contain?
A Validation Plan, User Requirements Specification (URS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), a requirements-to-test traceability matrix, a deviation log, and a Validation Summary Report (VSR) - each approved by QA.
Can a template be used as-is for validation?
No. A template is a starting structure. It must be adapted to your intended use and risk assessment (CSA under GAMP 5), then executed with real evidence and approved. Using an unadapted template is itself an audit finding.