Only the
statistics you need and the decision you expect
The objective of your analytical procedure is to quantify accurately;
the objective of the validation is to provide laboratories as well as
regulatory bodies guarantees that your method can achieve its goal; the
objective of
e-noval/Seelva
is to join both objectives adequately by estimating and displaying the
performance of your analytical procedure.
That's the most efficient way to reliably
provide quantified evidence that your analytical procedure is likely to
quantify tomorrow's samples with the accuracy you wish.
There is one objective for your analytical procedure; e-noval/Seelva gives you
only one related decision.
A
service easy to use, results easy to interpret
e-noval/Seelva is an
internet based service that requires you to only have a browser,
an analytical procedure and your data. The latest technology
makes e-noval/Seelva easy to
install, to maintain and to disseminate throughout your organization
while being of the best quality. Optimally designed graphical display
and interactive information make its use natural; its interpretation
obvious and so requires limited trainings.
A
solution fully validated in compliance with regulatory documents; a
validation report ready to use
e-noval/Seelva is not
just another software, nor another friendly website.
e-noval/Seelva
is a true industrial solution for
your laboratory that has been developed, validated and documented
following strongest standards and is compliant to 21CFR-Part 11. Those
outstanding standards in quality were achieved by partnering closely
with Qualilab, a company well established in laboratory quality and
software validation.
Computations and delivery are performed using SAS 9.1 system, the
definitive reference of quality in number processing.
The final output itself, a PDF non-editable report you can tailor to
your needs, constitutes the definitive document you release for
demonstrating the validity of your analytical procedure. In a couple of
minutes you get a report that is clear, intelligible, self-explicit and
validated!
Control
and understand your risks
Make
your procedure compliant with regulatory documents, be confident in
your procedure
Too often the analyst has to make
trade-offs between being compliant with most regulatory documents and
releasing a procedure that provide reliable results. The concepts and
approaches implemented by e-noval/Seelva
will make you confident in your
method while being in accordance with all regulatory bodies. e-noval/Seelva
is the ultimate scientific
achievement in the area resulting from more than 8 years of in depth
brainstorming and scientific development between experts from academia
and industry specialized in analysis and statistics. With e-noval/Seelva
you will be able to fulfil
regulatory requirements without pain while being able to control and
minimize the risk of use of your analytical procedure.
Flexible,
optimized and scientifically relevant
Offers
the flexibility your expertise deserves
As long as you perform the minimal set of experiments e-noval/Seelva
will recommend you to process, no
matter the range of your method, the number of levels or
replicates, e-noval/Seelva
will adapt to your way of working
and will allow maximizing the capabilities of your methods. The
openness of the service, jointly with the interactive interface, will
allow you to tailor dynamically the statistical analyses and the
reports to the specificities of your environment and processes.
A wide
variety of calibration models to achieve accurate results
As pointed recently in a FDA guide, the simplest model describing the
relationship between the quantity and the response must be used as a
calibration model.
e-noval/Seelva
goes well beyond! e-noval/Seelva
will automatically suggest the
simplest model that maximizes the accuracy of your method. You
developed a method to quantify accurately, not to fit simple models,
that's obvious, isn't it ?
Find
the most extreme and reliable limit of quantitations
The objective of most analytical procedures is to be able to quantify
accurately over a large range of values and in particular to remain
accurate for extremely low quantities. New algorithms built
into e-noval/Seelva
will help you to find the lowest
(and largest) limits of quantitation you can rely on blindly.