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About
Us
Because of our blue-chip customer base and our unrivalled Knowledge
and Experience (from whence the name “KE” comes), in
this very complex environment, we have grown to a full-time workforce
of 20 dedicated consultants, with the skills demanded by our customers
in Ireland, the US, the UK, Mainland Europe, and Singapore. We are
located in our own 2,000 square foot facility which the company
purchased in 1998, in Barryscourt Business Park, in Carrigtwohill,
on the edge of Cork City.
Computer systems validation is one of the more challenging tasks
required to deploy any complex system or combination of systems.
FDA regulations require pharmaceutical manufacturers to provide
the necessary documented evidence that computer systems perform
as specified and can be trusted to continue to do so. Some of the
activities necessary to do this include:
Formal and detailed specification
of computer system requirements
Formal and detailed specification of system design
Qualification of the design by testing it against the requirements
Qualification design elements via software and hardware unit testing
Maintenance of the system's configuration in a controlled state
KE Consulting Group provides services to help pharmaceutical companies
with these and other computer systems validation tasks. The company
can assist with the writing of validation plans, requirements and
design specifications, and test plans for systems and software.
KE Consulting Group's consultants have expertise with a number of
computer hardware and software technologies, and they can design,
perform, and audit detailed, module level software testing.
An important additional service that the company offers is that
of retrospective validation of legacy systems. Operating computer
systems that have performed acceptably for years should not have
to be replaced for lack of documentation. KE Consulting Group can
audit, test, and document the performance of these systems, bringing
them into compliance with validation requirements. We can also perform
full 21 CFR Part 11 Remediation analyses, and risk assessments.
Unlike other consulting firms, it is our philosophy to transfer
skills into their clients' organizations and to enable pharmaceutical
manufacturers to do their own validation work. The company's consultants
can participate in validation projects as contributors and, at the
same time, serve as trainers, coaches, or reviewers, creating an
able validation team in the process. |
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