Even today paper-based documentation is still quite common in many manufacturing plants, although it tends
to be unstructured and therefore inefficient. More often than not the documentation is a mix of manually entered
and system-generated process data. So the Batch Record Review to assess and release deviations becomes a
time-consuming process.
PAS-X offers configurable electronic release workflows. The process data is available online, and the users can
use it as basis to valuate deviations at once. The release-relevant electronic batch record does not only contain
the entire process documentation but also the deviation report. All deviations and events are depicted in a concise
and transparent manner. Thus, all departments involved are enabled to give a quick, secure, and efficient assessment
and electronic release. Lead times are reduced significantly.
PAS-X verifies manually entered data like input materials, equipment hours, or process parameters by comparing them with the specifications in the batch record. The software recognizes deviations and immediately alerts the user, so they can take adequate countermeasures with no delay. Moreover, the system requests the user to file a comment on the deviations. The entire process is documented in detail. Barcode identification serves to verify the use of materials and to set up a consistent batch tree.
Electronic Equipment Management
enables the efficient creation and automatic maintenance of
electronic logbooks. Comprehensive status monitoring effectively prevents the use of wrong equipment like
non-sterilized or inadequate filters, tanks or containers.
The electronic process monitoring is designed as an Early Warning System
that calls for the user's attention even before the limiting values are exceeded. The system continuously
monitors the process values and generates a tendency. As soon as one of the parameters is anticipated to
approach defined limiting values if the tendency does not change course, the systems reports a critical
trend. This leaves enough time for the user to adjust the process with corrective actions.
The integration of production, in-process control (IPC) and quality assurance makes it easier to master the
processes and eventually minimizes the costs for faulty batches.
![\"\"](\"/images/1px.gif\"){kind=spacer}
Lead Times