Project Phase

The Project Phase of Validation of an automation system is the phase where a new system is specified, build, verified and handed over to the system owner. Some of the principals can be used for validation of existing systems, but that method (Retrospective Validation) is not described here.

Validation of a new automation system is done using the V model. The V-model divides the Project Phase into Planning, Specification, Configuration and Coding, Verification and Reporting.

  V model











With Validation "plan before act" is required by the regulations. Planning covers all required activities, responsibilities, procedures and timelines.

Deliverables for this step are:

  • Project Definition
  • Initial Risk Assessment
  • Validation and Project Plan (related to the Validation Master Plan)



The specification part of the Project Phase starts with the User Requirements Specfication (URS). The URS is a document, owned and written by the user, that describes all requirement in a SMART way. All requirements must have a unique identifier to enable traceability of the requirements through all validation steps.

Deliverables for this step are:

  • Project Definition
  • Risk Assessment
  • Supplier Assessment
  • Functional Specification
  • Hardware and Software Design Specification
  • Design Qualification


Configuration and Coding

Configuration and Coding is the most time consuming part of the project. The implementation of hardware and software is dependent of the quality (system) of the supplier and engineer.

Deliverables for this step are:

  • Software modules
  • Hardware modules
  • Code review reports



Verification, also named Qualification, is the step where the software and hardware is verified against the requirements.

Deliverables for this step are:

  • Factory Acceptance Test (FAT)
  • Site Acceptance Test
  • FAT, SAT protocols
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • IQ, OQ, PQ protocols

ISPE published a Good Practice Guide on Testing.


The reporting step is completing the validation in the Project Phase.

Deliverables for this step are:

  • Validation Summary Report
  • System Handover