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"Specifications
form the foundation for all GMP
systems"
– Paul
McKim former FDA regional inspector
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Here for Downloadable and Printable
Product Flyers
Specifications
for GMP systems and processes are
unique. Unlike traditional engineering
specifications, GMP specifications
consist of many different types of
interrelated data that, when combined,
make up a specification for a system,
process or facility. For example, a GMP
specification for a bioreactor may
include many different tables of data
for the mechanical and control
components, but it also must include all
of the drawings, manuals, SOPs, spare
parts lists, etc. Further, these
specifications must be associated with
each other to provide for efficient
auditing and change control processes.
Traditional
database systems do not accommodate
multiple data types and provide no
ability to associate one specification
to another. Now, there is a tool
designed specifically for GMP industries that helps organize,
document, interrelate, share and control
all of your GMP specification
information in one structured, visual
database.
cGMP
Systems™ Engineering Specification
Module (ESM), a module in a suite of
integrated GMPware™ software
applications, is a database application
that collects all of the GMP
specification information for a
facility, its equipment, systems and
processes and organizes this information
in an intuitive and logically structured
database.
Designed
to facilitate efficient use and
management of specification data, ESM
can store almost any kind of
information. Not only is the information
stored in a logical tree structure, but
its relational features allow you to
relate specifications to each other –
an important requirement for change
control.
When
used with the GMPware Validation
Protocol Module, the specification data
contained within the ESM database is
automatically linked to each Validation
Protocol. No longer is it necessary to
manually transpose the data from
engineering drawings and spreadsheets to
the protocol, thereby reducing the costs
associated with protocol deviations and
errors.
Click
here to contact us for an ESM
demonstration today. |
