"reduce
or eliminate the potential for procedural
errors in the workplace"
Batch
Records/Device History Records
- improve "right
first time" pass
- reduce
documentation errors
- reduce
review and product release cycle time
- eliminate
redundant data recording and documents
STI's
redesign process for production and quality
records improves and standardizes the content,
format and data flow in the records and other
cGMP related documentation. The redesigned
record eliminates unnecessary and redundant
entries, reduces the potential for error
and is easier to complete and review.
Laboratory
Forms/Methods
- replace
your laboratory notebooks
- reduce
sample processing time
- improve
productivity of the laboratory personnel
STI's
redesign process for laboratory documentation,
procedures and processes reduces the time
required for the Analyst to document Analytical
Method information, record the Analytical
Testing results and the time required for
data review and approval.
SOPs
- reduce
and eliminate the potential for procedural
errors in the workplace
- eliminate
redundant and unnecessary work practices
- have
work instructions that "fit" the
process, can be easily used for training,
reference and skills enhancement
STI's
redesign process streamlines and simplifies
procedures making them "user friendly",
providing a design and format where instructions
are easy to read, use, understand and follow.
Where applicable, redesigned procedures clearly
state operating specifications, parameters
and process control requirements for cGMP's
and process control.
Process
Development/R&D Documentation
- reduce
cycle time for documentation development
for R&D/Process Development groups
to commercial production
STI's
redesign process prepares guidelines and
templates for commercial production that
can be utilized by R&D/Process Development
groups to reduce document development/transfer
time to commercial production.
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