Understanding
how to prepare a project plan covering the
key events of an EBR/MES implementation based
on user requirements, system functionality
and the manufacturing and packaging processes
is not an easy task.
STI's
documentation redesign process is the first
step in preparing for EBR/MES and compliments
EBR/MES design, project planning and implementation
by identifying and validating user requirements
such as:
- Defining
the necessary work instructions, data
and e-signatures to meet regulatory and
process control requirements
- Grouping
steps into logical unit operations to minimize
the number of e-signatures and system transactions
- Rationalizing
all data requirements and consolidation
of data entry requirements to eliminate
redundancy and duplicate entries
- Defining
data formats, sources, parameter values
and acceptable ranges
- Ensuring
process flow and steps are correct so sequence
and parameter control can be implemented
In
addition, STI's documentation redesign and
process mapping expertise can:
- Identify
opportunities for integrating islands of
automation and documentation in preparation
for EBR/MES, EDMS, LIMS, CAPA tracking,
TM, SQM, and PM systems
- Develop
prioritization and implementation strategy
- Identify
and justify necessary interfaces with other
systems
- Reduce
implementation time, investment and resource
requirements
"STI's
documentation redesign process is the
first step in preparing for EBR?MES implementation"
How
can STI help?
Contact
Us
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