In the
pharmaceutical and the food
industry it is a requirement to
be able to document changes made
to the production equipment. It
is also necessary to keep track
of maintenance procedures, how
often they have been executed -
and whether any changes have
been made to procedures over
time. These requirements are
specified by the American Food
and Drug Administration (FDA)
and especially within the
pharmaceutical industry
validation according to FDA
requirements is a crucial
factor.
The APIPRO
Change Logging Module has been
developed in close co-operation
with API PRO customers who need
to pass the validation of the
American Food and Drug
Administration (FDA). It
provides a tool capable of a
complete and reliable logging of
changes to data "close to the
process", which is an absolute
requirement to pass the
validation. However, the change
logging functionality is a
valuable tool in every QA-system
in any industry.
With the change
logging module, all changes in
the central tables of the API
PRO system will be logged. This
will make it possible to see
(and document) the status of for
example a machine at any time
throughout its life time. This
will give you full traceability
for all machinery, all working
procedures, etc.
 Click to enlarge |
Click to enlarge |
