Dividella Qualification Services0 pages

COME TO THE SOURCE
DIVIDELLA QUALIFICATION SERVICES

COME TO THE SOURCE,
BECAUSE …

Our core values

Our goal is to make the qualication process a sucess for
each of our cutomers. Your qualication project manager
will begin with the project at an early stage, to help guide
the project through the planning, preparation, and nally,
the execution phases. We strive to provide our customers
with the tools and support necessary to get their system
qualied in as short a time as possible with the optimal
resource expenditure.

… OUR QUALIFICATION PACKAGES
ARE MODULAR, LIKE OUR MACHINES.
Dividella has standard qualication packages available to
help meet your machine qualication needs. In addition to
standard packages, additional supplementary documentation is available to „round out“ a particular package. Risk
Analysis and Design Review Workshops are examples of
these supplementary materials.
However, Dividella can also assist you in analyzing your
special requirements and then developing a customized offering that is individually tailored to meet your specic needs.
For example, if you are attempting to implement the
ASTM E 2500 standard, Dividella can partner with you
to develop a verification plan and testing strategy that
matches your company‘s particular implementation approach.
Support from Dividella is more than just documentation.
Our qualication specialists can support you at our site or

yours with expert assistance to meet your needs during the
execution phases as well.

COME TO
THE SOURCE
Dividella Qualification Services

… YOUR NEEDS MAY CHANGE OVER TIME.
Dividella can, of course, support our customers with a wide
range of additional options and retrots for our machines –
to assist you as your packaging needs change. In addition
to machine modications, we can also provide the support
necessary to advise in re-qualifying the new and or modied
functionality. Your qualication project manager will assist
you to develop a qualication strategy for the machine retrot. We can support the project with an updated Risk Analysis,
Design Documents and Testing Documents. A detailed description of the modications is also provided to summarize
all the necessary information for use in your internal change
control process.

… RISK MUST BE MANAGED.
Risk and risk assessment are critical issues in today‘s regulatory and business environment. It is imperative from both
a quality and business perspective that (project) risks are
assessed correctly and mitigated appropriately.
Dividella has the knowledge and expertise to assist our
customers during the risk assessment process and the
technical know how to come up with cost effective solutions
to mitigate those risks.

Dividella AG 03.2014

… OUR FOCUS IS ON THE CUSTOMER.

As market leader for innovative pharma packaging solutions, we allow
no compromises in the quality of our products and our customer service.
With our engineering and packaging development expertise, we contribute
to our customers' success. We act in partnership and we are personally
responsible for the results of our work.

Dividella AG
Werdenstrasse 76 · 9472 Grabs · Switzerland · www.dividella.com
T + 41 81 750 33 66 · F + 41 81 750 33 43 · mail@dividella.ch

www.dividella.ch