"Validation means confirmation by examination and
provision of objective evidence that the particular requirements
for a specific intended use can be consistently fulfilled."
(U.S. Food & Drug Administration, 1998, 21CFR820.3)
Our software quality policy is to provide products that
consistently fulfill the specifications as presented in our
technical documentation (primarily the User's Guide) and sales
literature.
Here is how we ensure that MultiSimplex®
fulfills our quality commitment:
1. Numerical and graphical output from the software is
validated by the following methods:
2. Software development is performed to ensure that the
overall quality goal is met:
Programming is based on written specifications.
Programming is done according to defined rules, and the
source code is well structured and documented.
The source code is highly modular, to facilitate error
detection, testing and maintenance. A software system is
used for version control.
The software goes through extensive internal pre-release
testing, alpha testing, to ensure that the specifications
are fulfilled. Especially important is usability testing.
Problems are recorded, forwarded to the development team,
fixed, and noted.
Each major new version (x.x) of the software goes through
extensive external testing, beta testing, by both qualified
scientific experts in the field and ordinary users. Problems
are recorded, forwarded to the development team, fixed, and
new beta-versions are shipped until all known major problems
have been fixed. This assures consistent results across
different hardware and software platforms.
The managing director takes the final decision about
release of a new commercially available version, after
reviewing the test results from alpha- and beta testing.
Problems (errors) reported after release are entered into a
log, forwarded to the development team, fixed, and noted.
Service releases are made with fixes to groups of minor
problems, or separately if a major problem occur. Service
releases are available free of charge to registered users.
3. We assist our customers in performing necessary
validation procedures themselves (as regulating authorities may
require):
All algorithms for experimental designs, optimization
methods and fuzzy set membership computations are published
in the MultiSimplex® User's Guide.
We provide bibliographic references to the scientific
literature describing the methods implemented in the
software.
4. We assist our customers in the efficient and correct
use of the software:
We provide a web site with in-depth information and
literature about the methods,
application notes, and other advice about the use of the software.
