Medical Design Briefs - July 2022 - 11

ically enforces the procedures.
The MES streamlines compliance
with FDA's Title 21 CFR
Part 11 for Electronic Records
and Electronic Signatures. It
also includes a quality module,
which shows trends and results
graphically (see Figure 5).
The MES imports picked lot
or serial numbers automatically
from the ERP, so the operator
only has to confirm a match to
materials assembled. As the MES
collects data from throughout
the shop floor, it provides context
as well, creating complete
traceability with all information,
measurements, and meta data
attached to the eDHR.
Live Data
Acquisition
Product
Traceability
Maintenance
Management
Personnel
Management
MES
Document
Management
Instead of inspecting or checking
process and product data after
a manufacturing step, the
system facilitates these functions
at the time of processing. As
measurements are collected, the
MES enables instant adjustment
of processes or flags issues to prevent
errors. Elekta can also remove
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Medical Design Briefs - July 2022

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Medical Design Briefs - July 2022 - Cov1
Medical Design Briefs - July 2022 - Cov2
Medical Design Briefs - July 2022 - 1
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Medical Design Briefs - July 2022 - 3
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Medical Design Briefs - July 2022 - Cov3
Medical Design Briefs - July 2022 - Cov4
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