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Computer system in the organization

The live system also needs an organization

Too many companies thinks that a live system does not need an organization apart from the application manager, and someone in the IT who supports it. If the system is used in more than one department or part of the organizatipon, this is deadly thinking. The system does not function without a proper organization.

System organization

A system organization 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 system needs an organization with different groups:

  • The system team
  • The sponsor team / owner group
  • Quality Assurance

System team

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

Application manager, 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.

Superusers, who work in the areas where the system is used. These are the primary trouble shooters for the users.

Sponsor team / owner group

The owner group is the "parliament" of the system. 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. Their most important job is to make decisions that the system team feels is necessary. A lot lof this is organizational issues, where the system team has no authority to make decisions. The cost of keeping the system alive needs to be charged to some part of the organization, and the owner group should each take their share of the cost if the company does not have a single pot of gold for these expenses.

Quality Assurance Unit - QA

QA has responsibilities for the quality in / for / around the system. They authorize all quality documentation during the live phase of the system. Examples are change control 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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