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Diegem, December 9, 2009 -- Toxikon, a
research laboratory that analyzes product safety in the life
sciences industry, recently hired CTG to validate its laboratory
scheduling software. CTG, an IT services and solutions provider,
recently developed a validation service, Agile Computerized Systems
Validation, which guarantees companies will pass government
inspections (e.g. FDA, EMEA).
Toxikon uses analytical and bio-analytical testing to determine
whether medical packaging and environmental factors have a negative
influence on drug efficacy. Its customers are pharmaceutical
companies, suppliers of packaging materials for medical purposes
and medical equipment (e.g. implants), and companies in the
biotechnology sector.
Developed Own Software
To efficiently organize its laboratory, Toxikon needed an easy
way to follow the progress of testing and analysis. The company
initially used Excel spreadsheets. However, with over 1,000
projects per year, this process was becoming unmanageable. Toxikon
therefore began searching in vain for a proper software
solution.
Kevin Breesch, quality assurance manager at Toxikon, explains,
"Our old Excel planning had become inefficient due to the
increasing number of projects. We researched the market looking for
the right software package to replace it. Unfortunately, we did not
find any. We decided to build the suitable software based on our
own specifications. Our customers constantly asked us about the
progress of project X, which phase project Z is in, etc. This
resulted in our Laboratory Organization Management system (LOM
system) with a Microsoft Access user interface. This software
provides a clear overview of all our projects and their state of
advancement. This allows management to analyse each department's
workload and provide personnel reinforcements and additional
resources where necessary to complete projects on time."
Software Validation
The life sciences industry is strictly regulated. Validation,
the procedure that proves ICT systems comply with legal
requirements, is mandatory in this sector, and ensures patient
safety. Companies such as Toxikon use software to support GMP and
GLP analysis and need to provide documented proof the software
actually does what it is supposed to do. That registration process
requires specialised focus and attention.
Kevin Breesch continues, "Writing software is one thing;
validation is another. This creates a lot of paperwork. You must
show your customers, in black and white, that the software you use
is effective and suitable for the intended use. It's a prerequisite
in this industry. That is why we looked for a player with expertise
in validation."
Jos Bollen, Director Europe at Toxikon, is satisfied with CTG's
work: "CTG has good references in the life sciences field and
it provided a proposal that suited us. Their Agile Computerized
System Validation (CSV) system allowed us to validate our
Laboratory Organization Management System in a short period of time
and still remain profitable. Our LOM system has also been screened
during GMP audits several times and the result was always positive.
"
Interaction with Developers Crucial for
Success
The ICT system validation process is labor-intensive and
time-consuming, as a large number of documents need to be
completed. Filling out just one of the required documents can take
several weeks, and few companies have the money and time to do
so.
Andy Nobibux, a pre-sales consultant with CTG's regulatory
compliance team, commented, "SMEs like Toxikon benefit from the
expertise of a good partner to guide them through the validation
process accurately, quickly, and efficiently. CTG met this
challenge at Toxikon. It took us two months to successfully
validate Toxikon's LOM system. The main keys to success were CTG's
pragmatic approach and the close interaction among all parties. We
successfully confined ourselves to the crucial documents for the
design phase, the test phase, and the validation report. Numerous
auditors even congratulated Toxikon on its validation
report."
Agile CSV Provides Unique Regulatory Compliance in
Belgium
Agile Computerized System Validation (CSV Agile) is a new
service for CTG, whose Belgian regulatory compliance unit has 42
people. The aim of this service is to help pharmaceutical companies
and laboratories like Toxikon with the validation of their ICT
systems. CTG offers expertise to both large pharmaceutical
companies and smaller SMEs to handle the unique conditions in the
Belgian market.
"Two things make this new service unique in the life
sciences market," said Fabienne Lens, director regulatory
compliance at CTG Europe. "With our experience in regulatory
compliance, we know how to significantly reduce the duration of
such long-term projects. We guarantee a savings of 30 percent and a
successful, problem-free audit. And if an audit doesn't run
smoothly, CTG will make every effort to work on the items that
cause problems, still aiming at successful completion. And all this
is for free if the elements to be adapted are within the project
scope. This is unprecedented in Belgium."
To schedule an interview with Fabienne Lens,
ESS Director European
RegulatoryCompliance at
CTG, please contact Bert Bouserie
Luna: 02 658 02 93 orbert@luna.be
About Toxikon
Toxikon is a Life Science and Contract Reasearch
Organization (CRO) which mainly performs 'compliance studies' to
product safety. The parent company is headquartered in
Bedford, Masss. Its European laboratories are
located Leuven, Belgium.
For more information: www.toxikon.be
About CTG
CTG is an international organization that provides a
full range of IT solutions and services to clients in diverse
sectors. Through an international network of offices
in North America and Europe, more than 3,300 IT professionals
provide solutions that really work. In Europe, CTG is
present in Belgium, Luxembourg and the United Kingdom.
CTG combines extensive knowledge with over 40 years
experience with a complete range of services and integrated
methodologies. Application Solutions, IT Service Management,
Regulatory Compliance and Testing within their field of
knowledge.
For more information: www.ctg.be