As of Release 4.0A, the following changes are valid with regard
to process data documentation:
Terminology
The following terms have been added
or changed:
Batch record
Record containing all
quality-relevant planned and actual data on the production of a
batch. This record is available as of Release 4.0A; see release
note Process
Data Documentation: Batch Record .
Order record
New term for the order-related
record, which used to be called process data documentation.
Process data documentation
Generic term for the batch record and
order record.
Print list for incoming inspection lots
To comply with the requirements
stipulated in the guidelines on Good Manufacturing Practices (GMP),
another print list has been included in the order record. The new
print list contains data of the incoming inspection lot for the
incoming inspection (post-process control).
Note that only one incoming
inspection lot may have been created for the order.
Note:
In the material master of the
material to be produced, you can specify that only one incoming
inspection lot may be created (see Lots for
MatDocItem field in the inspection data for the
incoming inspection).
Print list for inspection lots
The structure and contents of the
print lists for inspection lots has been revised. They now contain
inspection specifications and inspection results.
Print lists for PI sheets
The print lists for PI sheets have
been enhanced as follows:
If a validation rule or warning has been defined for an input
value, the validation rule or warning is displayed after the input
value or, in repeated data requests, after the table.
If a variable has been defined for a value, the variable is
displayed after this value or, in repeated data requests, after the
table.
Calculation formulas are displayed after the calculated
value.
If signatures for invalid input values have been executed in a
PI sheet, these values are numbered. The values are listed at the
end of the PI sheet along with the signatures and dates.
Change system parameters in customizing
The IMG activity Define user list has
been deleted and replaced by the new activity
Develop enhancements
for process data documentation. Using the new
activity, you can develop the user list as a customer enhancement.
This means that it will not be overwritten by release upgrades.