Validation protocol of ERP system Template – Word Download

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XXX Validation Protocol

  1. Introduction……………………………………………………………………………………………………………………………………. 1
  2. Goal…………………………………………………………………………………………………………………………………………………. 1
  3. Scope……………………………………………………………………………………………………………………………………………… 1
  4. Responsibility……………………………………………………………………………………………………………………………….. 2
  5. Validation steps…………………………………………………………………………………………………………………………………………. 2
  6. Validation protocol……………………………………………………………………………………………………………………………………….. 2
  7. Design Qualification………………………………………………………………………………………………………………………………….. 2
  8. Design project………………………………………………………………………………………………………………………………………… 2
  9. Tasks – Planning – Milestones………………………………………………………………………………………………………….. 2
  10. Engineering environment………………………………………………………………………………………………………………….. 2
  11. Resources………………………………………………………………………………………………………………………………………………… 2
  12. Software life cycle model…………………………………………………………………………………………………………………… 2
  13. Reviews…………………………………………………………………………………………………………………………………………………….. 3
  14. Software configuration management…………………………………………………………………………………………… 3
  15. Problems resolution management………………………………………………………………………………………………… 3
  16. Documentation…………………………………………………………………………………………………………………………………. 3
  17. Installation Qualification…………………………………………………………………………………………………………………………. 4
  18. Goal………………………………………………………………………………………………………………………………………………… 4
  19. Protocol………………………………………………………………………………………………………………………………………….. 4
  20. Documentation…………………………………………………………………………………………………………………………… 5
  21. Operations Qualification…………………………………………………………………………………………………………………………. 5
  22. Protocol……………………………………………………………………………………………………………………………………………… 5
  23. Documentation…………………………………………………………………………………………………………………………………….. 6
  24. Performance Qualification…………………………………………………………………………………………………………………. 6
  25. Protocol…………………………………………………………………………………………………………………………………………………. 6
  26. Documentation…………………………………………………………………………………………………………………………………… 6

III.    Activities supporting validation and after validation…………………………………………………………………….. 7

  1. Training of personnel…………………………………………………………………………………………………………………………… 7
  2. Revalidations………………………………………………………………………………………………………………………………………… 7

 

I.                  Introduction

A.                Goal

This document defines the validation protocol of XXX system.

It aims to determine that XXX system consistently performs as intended by running the system and recording all relevant information.

B.                Scope

The scope of this validation protocol is XXX system, it includes:

  • List HW and SW parts of the system.

 

The level of concern of XXX system is High/Moderate/Low

C.                Responsibility

The system owner is …

The person responsible for the validation is the system owner/or anybody else. He/she:

  • Prepares the protocol,
  • Organizes the validation activity,
  • Conducts the validation activity as defined in the protocol,
  • Prepares the report

D.               Validation steps

The steps of validation are:

  • Design Qualification,
  • Installation Qualification,
  • Operations Qualification,
  • Performance Qualification.

Delete steps which are not mandatory for XXX system and add rationale below :

Design Qualification is not applicable hence …

Installation Qualification is not applicable hence …

Operations Qualification is not applicable hence …

Performance Qualification is not applicable hence …

II.               Validation protocol

Delete the sections which are not present in XXX system validation protocol, according to validations steps above.

A.                Design Qualification

1.                 Design project

Describe the design project. This section can reference any other relevant document, which describes the design.

EG : the design is described in the software development plan xxx.

2.                 Tasks – Planning – Milestones

The planning below contains all tasks of the project and the links between tasks.

OPTIONAL SECTION Insert a table or list or diagram describing the planning.

3.                 Engineering environment

OPTIONAL SECTION What kind of workstation / server do you use and every other hardware.

4.                 Resources

OPTIONAL SECTION

If specific resources are need for the project such as a calibrated measurement tool or a simulator, they shall be identified, referenced and managed in configuration.

If not, add the following sentence

There is no particular resource needed for the project such as a calibrated measurement tool or a simulator. Hence, no specific identification of resources is needed for the project, the hardware and software resources are interchangeable COTS.

5.                 Software life cycle model

OPTIONAL SECTION Waterfall / RUP / Agile, quote your model

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