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:
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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