At
STI, our consultants do not perform paper to paper
documentation redesigns. STI consultants assess current
documentation practices and outline opportunities
for improving the documentation flow, layout, identify
compliance gaps, requirements, and unnecessary, redundant
information by process mapping (displaying) the records
on what is referred to as the “brown paper”.
STI
consultants involve client personnel in the decision
making process and conduct the following events during
the process:
- interview
and review opportunities with the Subject Matter
Experts (SMEs)
- workplace
observations to verify actual practice vs the work
instructions in the document
- development
of the preliminary redesign
- pilot
test the redesign with the SMEs
- document
the history of changes and justifications made
to the document to support routing and approval
- redline
and/or redesign the appropriate SOPs and forms
based on changes made to the redesigned batch/device
record document
- if
necessary, provide training to personnel on the
redesigned document
"Leaving
a redesigned system owned by the client
that is easy to maintain”
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