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| Associations |
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Associations
are unique to ESM and
are designed to
specifically address
several specific GMP
needs. One of the
greatest problems faced
in the GMP industry is
the need to evaluate the
impact a change may have
on ancillary or support
systems or documentation
for the item being
changed. Often, the
person(s) reviewing a
requested change have no
way of knowing what the
effect of the change
will be on other
documents or
specifications. ESM
solves this problem by
providing a convenient
mechanism to relate or
"associate" an
object in the database
with another object in
the database. |
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ESM
allows you to associate
any kind of ESM object
to another object. You
can associate a document
to a component, a
component to a
component, a folder to a
document, etc. |
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| Document-
or File-based Data |
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While
much of the information
that defines a
specification can be
stored in a traditional
database table, other
types of information
comprise GMP
specifications, also. |
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Documents
are a good example of a
non-tabular form of a
GMP specification. A
simple process or system
description written in
Microsoft Word, for
instance, may be
considered part of a
system specification.
Similarly, an AutoCAD
drawing or a list of
SOPs or User Manuals
could be considered part
of a GMP specification.
ESM
makes it easy to add
documents, drawings and
files of any type to a
GMP specification.
Often, these files are
stored on a network
server but due to
obscure naming practices
may be difficult for
anyone other than the
owner to locate. ESM
lets you link these
documents to the
database to make it easy
to collect these file
references into one
logical, structured tree
that everyone in the
company can access.
Note
that files do not have
to be moved in order to
be linked to the
database; they can
reside anywhere within
the network so changes
to your existing naming
conventions and storage
conventions do not need
to be made. |
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| Import
Existing Knowledge |
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What
to do with legacy data?
ESM makes it easy to
import existing
knowledge into the
database. Using ESM’s
Get External Data
utility, you can bring
data from existing Excel
spreadsheet/databases
into ESM.
Simply
specify the spreadsheet
containing the data you
wish to import and map
the fields to the fields
in the ESM database.
Your data is
automatically entered
into the system. Now
everyone in the company
can access the data. |
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| Organization
of Specification
Information |
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One
of the greatest problems
faced by pharmaceutical
firms today is locating
accurate specification
data. |
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The
above questions are
often heard from within
various parts of most
pharmaceutical
organizations.
Unfortunately, the
answers often vary
depending on the type of
specification data being
sought, or worse yet,
may depend on the
person(s) looking for or
answering the question.
ESM
solves the problem by
providing one shared
source of data that
everyone can use to find
specification
information. ESM’s
tree structure is a
familiar and logical way
to present structured
information.
The
ESM tree structure
organizes information
and data into logical,
groups or categories.
All of the information
for a system, process or
facility can be grouped
into a branch of the
tree. Each branch of the
tree may be used to
represent a different
kind of information or
type of information. The
flexibility of the tree
structure allows for an
infinite amount of
customization to meet
your particular needs |
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| Query |
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ESM
has a powerful search
engine that allows you
to build sophisticated
database queries to find
the information you are
looking for. Queries can
be established to find a
single item or a
collection of items
within the database.
The
easy to use ESM query
wizard walks you through
the process of building
your query. If needed,
full Boolean logic
support is available for
your query. When your
query has been built and
run, you can send the
results of the query to
Microsoft Excel for
further processing. Your
query can, of course, be
saved for later re-use. |
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| Security |
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ESM
models the industry
standard Microsoft NT
security schema, whereby
each user has a unique
ID and password. ESM
also supports the
"group"
structure. Each user can
be a member of one or
many groups. Each group
can be assigned an
access level for any
collection of groups
within the ESM database. |
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| Specification
Generation
When
asked, "What do you dislike
most about your job?", a
group of engineers unanimously
responded, "Writing
specifications!"
ESM
takes the trouble, time and
inconsistency out of writing
specifications by writing them
for you. Using standard
Microsoft Word document
templates, ESM collects all of
the specification data entered
into the ESM database for a
system, area or even facility
and creates a detailed,
standardized specification
document. |
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| Standardization
(preferred parts,
standard system
templates) |
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ESM
helps standardize the
way specifications are
defined by utilizing
standard table
definitions and
structured specification
trees.
Standardized
tree structures for
common systems are
supplied with ESM. Using
ESM’s Database
Administration Program
(DAP) the standard
system configurations
can be modified to
reflect your
organization’s
standardized business
practices. Additionally,
new system structures
can be added. Each time
a system is added to the
ESM database, the
structure is built from
the standardized
configuration defined by
you. |
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ESM
table definitions are
defined by you to
contain the information
your organization
considers to be
important. Each time
data is entered into an
ESM table, the data
format and content has
been pre-defined, thus
preventing individual
interpretation of
"what’s
important".
Further
strengthening ESM’s
standardization features
is the Preferred List.
The preferred list is a
configurable list of
preferred
parts/components/objects
that is pre-populated
with data. The preferred
list makes it easy to
enter data consistently. |
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| Tabular
Data |
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Much
of the data that
represents equipment,
system or process
specifications can best
be defined in a
traditional table
structure.
ESM
provides an almost
infinitely flexible
table structure allowing
you to define tables
which can handle any
form of table-based
data. Tables can contain
text, date, numeric,
binary and even OLE
data. Tables can even be
changed
"on-the-fly"
after they have been
created so you are never
locked in to a table
definition during
initial system
configuration. |
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ESM’s
preferred parts feature
helps you standardize on
a pre-defined list of
parts or components that
you want to use whenever
possible. Preferred
parts improves
standardization and
reduces data entry time
for repetitive
specification
information. |
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| Track
Changes |
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How
many times have
you been
reviewing a
specification
(either your own
or someone
else’s) and
asked yourself,
"When was
this change
made? And
why?"
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ESM
incorporates a
multi-level
Revision History
feature that
gives you the
flexibility to
track and
control changes
to ESM files and
database
entries. You can
set the Revision
History level
for any object
in the ESM
database to a
level
appropriate for
that object. In
some cases, no
Revision History
is needed at
all. As a
specification
progresses
through its
lifecycle, you
may want to have
a reminder that
asks you if you
want to enter a
Revision History
reason for a
change. Near the
end of the
lifecycle, you
may want to
force the user
(or yourself) to
enter a reason
for every change
made to the
specification.
ESM provides you
with the ability
to set the
Revision History
level for every
object in the
database. |
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The
Revision History
for an ESM
object can be
viewed in detail
by simply
clicking on the
Revision History
tab within ESM.
Full audit trail
capability is
available to
enforce CFR Part
11 compliance.
The
Revision History
feature is an
important aspect
of any GMP
software and is
found in all of
cGMP Systems
software
products. |
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| VPM
Integration
One
of the most difficult problems
facing validation personnel
worldwide is the issue of the
ever-changing specification.
Although validation documents
are supposed to be based on
specifications, frequently this
does not occur. Sometimes
specifications do not exist, or
they are difficult to locate or,
more often, they are available
but not up-to-date. Regardless,
the protocols must be generated.
Frequently,
protocols are generated from old
or erroneous specification data.
The result? Erroneous protocols
that either fail their
acceptance criteria or produce
deviations or discrepancies that
must, in turn, be explained.
These problems result in
increased cost and time.
cGMP Systems
has solved this problem by
dynamically linking the protocol
documents to the specification
data they are based upon. No
longer must a validation person
track down the most up-to-date
specification for a piece of
equipment or a process, the
protocol automatically is linked
to the correct data. The
specification data is stored in
the ESM database.
Protocols
can be updated with the most
recent specification data, thus
eliminating the errors produced
when protocols refer to
inaccurate specification data.
This
revolutionary feature is
available to users of both the ESM and VPM
modules. |
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