The provision of services to enhance the quality of IT processes by means of support activities such as: definition of quality system model, issue of quality plans for building and maintaining information systems; preparation of a quality package (set of documents supporting the quality of software).

The activities related to software quality include the production of a set of appropriate documents and the dissemination of the methodologies among the partners involved in software development through consultancy on site and follow-up controls

The main areas of activity for this project are:

•    Development of a Validation Master Plan: The purpose of validation is to demonstrate that the HealthAgents system continuously and satisfactorily executes the functions it is designed to perform.

 •    Activities and strategies for system implementation, including:

•    Project user requirements

•    Software Developer Quality System review and monitoring

•    Validation Documentation Templates and Guideline

•    System Management SOPs templates

•    Technical Document Review

As far as the Software Developer Quality System is concerned, attention will be focused on Software Development Methodology. That is the set of principles, practices and procedures, which are used to define, develop, and implement information systems, including documentation.

 •    Validation of the HealthAgents system: Validation is applied to many aspects of regulated environment. In each case the objective is to produce “documented evidence, which provides a high degree of assurance that all parts of a facility will consistently work correctly when brought on-line”.

Experts within the consortium Pharma Quality Europe