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PAS-X Business Functions
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| PROCESS QUALITY CONTROL |
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| Continuous Quality Control during the Manufacturing Process |
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Quality control is of vital importance during the manufacturing process. Its objective is the continuous
control and improvement of product quality.
PROCESS QUALITY CONTROL provides
functions in PAS-X which you can be used to process deviations during the ongoing
manufacturing process. Even more important, however, are its preventive and flexible
effects on quality, which are achieved using functions that support process-analytical
quality control - online, inline, and at-line. PROCESS QUALITY CONTROL supports your
implementation of Process Analytical Technology (PAT) or advanced Quality-by-Design
(QbD) concepts.
 Article "Creating QbD/PAT Management Awareness"
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| Electronic Batch Recording as the Basis |
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The step towards paperless documentation is a milestone on the path towards
more reliability and documentation quality in the pharmaceutical manufacturing
sector. Electronic user prompting guides the operator securely through all
production steps of the manufacturing process. PROCESS QUALITY CONTROL is a
logical and consistent add-on to the ELECTRONIC BATCH RECORDING business
function. PROCESS QUALITY CONTROL, with its
core function of workflow-based deviation management, makes good use of
all the benefits of Electronic Batch Recording, and it safely controls
all critical parameters.
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| Automated Deviation Tracking |
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With the help of the ELECTRONIC BATCH RECORDING
business function, all set values and tolerance bands are uniquely
specified within the process, and are electronically verified. On
recognition of deviations, PROCESS QUALITY CONTROL informs the operator
and prompts for a response. The electronic early warning mechanisms in
PROCESS QUALITY CONTROL enable the user to take corrective action regarding
the production process the moment any negative trend is recorded. Every single
deviation is documented.
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| Classifying Deviations |
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The system prompts the operator to classify
recorded deviations and to add a comment. At the same time,
PROCESS QUALITY CONTROL checks whether a second electronic signature is
required. The criteria for required second signatures can be customized
within the system. Furthermore, subsequent actions can be parameterized.
The system can therefore, for example, in the case of certain deviations,
prompt the operator to notify the supervisor in charge before continuing
with the process.
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| Evaluating Deviations |
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An electronic workflow ensures that deviations can be evaluated by
different members of staff and various departments. This method delivers
two vital benefits: On the one hand, time-consuming distribution of paper
documents becomes redundant; on the other hand, target and actual process
data, required for evaluation, are made readily available.
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| Analyzing Deviations |
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PROCESS QUALITY CONTROL
creates an electronic deviation report for the electronic batch record.
The deviation report is part of the electronic batch record.
A condensed report of all deviations allows the batch record to be
released efficiently and with no unnecessary delays. The release process
is controlled by a parameterizable electronic document workflow.
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| Audit Trail |
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Once reported and evaluated, the deviations are stored within an audit trail. The system documents electronic signatures in compliance with the 21 CFR Part 11 requirements.
PROCESS QUALITY CONTROL
therefore improves the performance of all release processes and, at the same time, fulfils compliance regulations regarding the documented pharmaceutical release process.
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