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Quality management and documentation
Process documentation principles
The documentation of reprocessing
represents a significant contribution towards
quality management in laboratories.
Proof that a validated process can be
replicated with each cycle is best achieved
by recording and documenting the most
important programme parameters on a
continuous basis.
Miele Professional offers its own complete
process documentation package. The heart
and soul of the system is the Segosoft Miele
Edition documentation software. Depending
on the requirements of clients and on-
premise conditions, various documentation
solutions are available. Miele machines
and their software are an ideal match and
interact perfectly.
The user-friendly Segosoft Miele Edition
allows full traceability and secure
documentation of reprocessing operations.
Traceability is guaranteed by recording
process protocols and plotting temperatures
and pressures - information is provided by
the machine itself via an interface.
Documentation made simple
Segosoft Miele Edition excels in terms of
speed, simplicity and efficiency gains. Once
a Miele washer-disinfector commences
operation, the software automatically logs
all relevant data during the reprocessing
cycle.Where appropriate, the user can
assess reprocessing results at a computer
and approve charges using a user ID and
password. In all, the approvals process
takes less than
10 seconds.
Digital documentation
Documentation is entirely paperless, saving
valuable filing space. This represents a
huge and convincing benefit compared
with manual documentation using forms
and templates. Documents are created
by the Segosoft Miele Edition in PDF/A-1
format in compliance with the ISO 19005-
1:2005 standard. This format was specially
designed for long-term archiving and
ensures excellent legibility over time. The
software also allows loads and cycles to
be approved with a user ID and password.
Legally, this has the same status as a
written signature on a document. This is the
result of new legislation in many countries
which has made digital signatures legally
valid. This digital signature reveals any
subsequent changes to documents and
reliably prevents manipulation.