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New Computer System Project

Planning to buy a new system

You company has decided to have a new computer system. How is this organized?

Project organization

A project team needs to be created. The size depends of course on the size of the company, the size of the system, and what the system is going to include. The project needs an organization with different groups:

The project team

The sponsor team / owner group

Quality Assurance

Project team

The project team is the "government" of the project. They are the active players who do all the work with the project. The team has the following members

Project leader, who is responsible for planning the work and following it up. He/she is also responsible for the resources. In most cases the leader comes from the area where the system shall be used (for example a chemist from the lab for a LIMS or other lab system), but IT persons may also be used.

Project members, with background from the area where the system is going to be used, and often also some IT persons with the IT technical knowledge.

Sponsor team / owner group

The owner group is the "parliament" of the project. They sponsor the money and other resources, and give guidance for what they want. They also make decisions when needed. The group has members and/or authority for all parts of the organization affected by the new system.

Quality Assurance Unit - QA

QA has responsibilities for the quality in / for / around the system. They authorize all quality documentation in the project. Examples are validation and qualification issues.


Want to know more?

Publications:

Segalstad: Validation of computer databases for GxP. Chapter in book Good Research Practices, edited by Nigel Dent, Butterworth and Heineman (1996) 475-485.

Segalstad: LIMS: M is for Management, Process Information Technology, June 2000 54-56.

 
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Sub menu Articles and Information: 

21 CFR Part 11

Standards and regulations

Validation Plan

Qualifications

LIMS

User Requirements Specification URS

System selection

Vendor audits

IT project organization

Live system organization 

 



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