Issue 4 Summer 2002 - Applied Biosystems

40
customer relations
SQL*LIMS Installed to
Streamline Product Release
Baxter BioScience, Neuchatel, Switzerland
T
he demands on pharmaceutical companies for
quality assurance based on accurate information,
from both the public and the regulators, are increasing.
At the same time, market competitiveness is becoming
ever more cut-throat, so it is more vital than ever that
products of verifiable quality be brought to market in
the shortest practicable time. This means that product
development and its associated information handling must
be as streamlined as possible. A drug under development
spends its life in the laboratory and therefore increasing
the productivity of laboratories is a high priority for the
pharmaceutical industry. The ability to capture, process and
disseminate information electronically has radically changed
the efficiency with which laboratories operate.
A key step towards improving productivity is the
implementation of a laboratory information management
system (LIMS). Deciding which system to implement is a
crucial decision for any manufacturing site, especially one
being built from scratch – a fact not lost on Alexandre Boillat,
the IS manager of Baxter BioScience’s new multi-product
biosciences facility in Neuchatel, Switzerland. The objective of
the Neuchatel site is to significantly reduce time-to-market for
Baxter BioScience’s next-generation therapies.
The Baxter BioScience division is responsible for developing
and producing therapeutic proteins, from plasma and
through recombinant methods, to treat haemophilia, immune
deficiencies and other blood-related disorders. Its portfolio of
therapies includes coagulation factors, immunoglobulins,
albumin, wound management products and vaccines.
Construction work at the $131 million Neuchatel facility
began in 1998 and production began on the site’s first product
- a recombinant protein-free manufactured Factor VIII therapy
for haemophilia - in late 2000. More products are scheduled
to come on line over the next few years, with the workforce
growing to around 400.
“We took great care in deciding our strategy,” Alexandre Boillat
explained. “We were looking around to see what systems were
available to help and support us. It was important that we got
the right one.”
From Left: Alexandre Boillat, IS Manager and Pascal Schneider,
project leader of the LIMS implementation, Baxter BioScience,
Neuchatel, Switzerland
Pascal Schneider, project leader of the LIMS implementation
at Neuchatel, knew that Baxter was keen to achieve economies
of scale and minimise costs by standardising systems across
the corporation. “Baxter chose the SQL*LIMS software from
Applied Biosystems as its corporate standard and we stayed
with that choice,” he said. The Neuchatel site was one of the
first in the world to implement SQL*LIMS v4.0.
At Neuchatel, the LIMS implementation team began
by focussing on a key utility – water. “Starting from this
point we developed a clear project vision for our LIMS,”
said Alexandre Boillat. Emphasising that a manufacturing
site’s water supply must be under tight control, he explained:
“In the pharmaceutical industry you have a lot of things
to do for the validation of products and there is a lot of
data. For example, water is a critical supply for us and
monitoring water treatment is a part of quality assurance.
The quality assurance people need accurate information on
this, among other things, to take the decision whether or not to
release a product. In fact, obtaining good information is a
critical part of the product release process.”
“We also asked ourselves how it would fit with other systems,”
he went on, “and how many stages would be necessary
to implement it. Finally, we also had to be sure that a
computerised system would be better than a paper-based one.”
Baxter BioScience, Neuchatel, Switzerland
Rule 21 CFR part 11
As LIMS begin to offer all the advantages of the latest
computer systems’ capabilities, so the paperless laboratory gets
closer and closer. Under SQL*LIMS, laboratory methodology is
built up using easy-to-use forms. From a single screen,
the operator can define test requirements such as which
components to assay, which calculations to perform on results,
whether to calculate the cost of testing, or which analyst or
instrument to assign.
Part of the FDA’s Rule 21 CFR part 11 rule requires the
implementation of a number of security features to control and
monitor an individual’s access to data. LIMS can meet these
requirements through password verification and by providing a
modular electronic signature option that works with any form of
signature, including biometrices.
At Neuchatel, the LIMS implementation team persuaded Baxter
to let them purchase the latest version of SQL*LIMS, v4.0.
Pascal Schneider said: “It’s a big improvement over previous
versions, compliant with the FDA’s regulations and that
was what we needed.”
Implementation
Having decided which system to purchase, the next step was
to set up a team to run the project. According to Pascal
Schneider, there were three very important considerations.
“Firstly, identifying the resources needed and then defining
roles and responsibilities. The third consideration, training,
was highly important. We wanted to transfer as much
as possible SQL*LIMS knowledge to the project team.
All the team members were involved in a week’s training.
At first, some of the laboratory people had difficulty in
grasping the unfamiliar jargon. It was very important for us to
have everybody involved in training, so they could pick up
customer relations
the terminology, as well as learn how to use the system and
how it was configured. It meant that everybody had the
same understanding of the product from the beginning.
Following a short period of time where we put the system
through its paces, we started to define the specifications
we needed. Significant efforts were made at this point
to ensure that all validation was performed within the
regulated environment requirements.” Alexandre Boillat added:
“From the local point of view, the day-to-day implementation of
the system and the support were very good. We were very happy
with the support from Applied Biosystems in Switzerland.”
Strong systems, strong support
With the system having been successfully implemented
for Neuchatel’s plant, attention is now being turned
to environmental monitoring. Over the next few years,
LIMS will also be used to coordinate in-process testing and
final product testing. “We now have to roll out the other phases.
Our policy for IS projects is always to involve end users.
They strongly participate along the way and then, when the
development of a system is complete, there are no surprises.”
Alexandre Boillat said. “Our project vision should be
implemented with the LIMS within three or four years.”
The procedure should be quicker next time around.
“We had limited knowledge of LIMS for phase one,
although our project organisation and team structure were
good. Now that we have some experience, it will be easier to
conduct the next phase.” Recognising the need to have a
flexible informatics solution to cope with an ever-increasing
volume of data, Alexandre Boillat added: “One day we will
have to see how SQL*LIMS will be interfaced with our
laboratory instrumentation.”
To help support customers like Alexandre Boillat,
Applied Biosystems has a professional services organisation
that provides Rapid Integration Solutions. “In the software
industry it is hard to find an application that is bug-free,”
explained Alexandre. “For us another challenge was to
receive appropriate support from the supplier to make sure
that the bugs are recognised and that they will be corrected.
We did not want to customise our system and have to deal
with these problems alone.”
For more information on:
SQL*LIMS Software enter: No. 430
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