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PAS-X Business Functions
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| ELECTRONIC BATCH RECORDING |
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| Electronic Execution and Documentation of Batches |
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Efficient electronic and thus paperless batch documentation is one of the core objectives in introducing Manufacturing Execution Systems in pharmaceutical production. In this, special attention must be paid to the regulations of 21 CFR Part 11 Electronic Records; Electronic Signatures.
With the ELECTRONIC BATCH RECORDING function of PAS-X master batch records are electronically executed and the processes and results are documented in compliance with the applicable statutory provisions. PAS-X ensures an error-free execution of the entire production process.
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| "Easy-To-Operate" User Prompting |
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ELECTRONIC BATCH RECORDING offers user-friendly, standardized operating dialogs for the whole production process. It covers all stages, such as the receiving of incoming goods, production and packaging operations through to the shipping of finished products. The user interface is graphical, but the system also visualizes batch records on screen in a paper-like fashion ("Paper on Glass").
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| Rules Enforcement throughout the Process |
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The batch record displayed on screen includes all work instructions as they are required. So, the user for example
finds bills of input materials with complex formulas for value calculation or specifications on
individual process parameters like limiting values for the temperature. Even complete Standard
Operation Procedures (SOP)
can be displayed on screen in their latest released versions when interfaced with a document
management system. With displays in bold red/yellow/green traffic signal fashion as well as dedicated role-based dialogs,
PAS-X ensures intuitive and ergonomic working for the user.
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| Role-based Workplace Concept |
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Following a role-based
workplace concept, PAS-X provides different optimized user display modes and dialogs reflecting a user group's specific role in the production process.
This means that various types of user interfaces are available for executing electronic batch records:
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- Industrial PCs
- Mobile terminals
- PDAs
- Mobile notepads with touch-screens
The use of Radio Frequency (RF) capable mobile terminals and notepads with integrated scanners allows for maximum flexibility and freedom of movement.
The work instructions as well as material plausibility checks based on scanner input can be accessed by every user at any place and at any required time.
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| Process Data View |
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A Distributed Control System (DCS) or Supervisory Control and Data Acquisition System (SCADA) may be
employed to control the process. In this case, the role-based workplace concept of PAS-X offers integrated visualization of electronic work instructions and process data.
This way, the user obtains a homogenous picture of the process state.
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| Equipment Integration |
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By integrating pharmaceutical process equipment via standardized interfaces PAS-X is able to exploit all relevant data of the equipment level:
- Electronic Records / Electronic Signatures in compliance with 21 CFR Part 11 (for documentation/archiving purposes),
- Specifications/download of recipe parameters to the machine,
- Operating state data,
- Operational time accounts, and
- Malfunction data and periods.
PAS-X archives all process data in a 21 CFR Part 11-compliant way, with a particular focus on CQAs and CPPs. All logged process data are thus available for
evaluations and as a basis for identifying the potential for optimization. (
MANUFACTURING INTELLIGENCE).
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| Deviation Handling |
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During execution on shop floor level,
ELECTRONIC BATCH RECORDING
continuously compares the captured ACTUAL data to the SET values set forth by the batch record. In the event of a deviation, the system immediately displays
a traffic-light alert at the quality control panel. The representation in red/yellow/green color enables
corrective user intervention into the process in good time.
These and other deviation handling functions further enhance the broad PAS-X portfolio and form a solid foundation for comprehensive deviation management.
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| Material Flow Control |
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ELECTRONIC BATCH RECORDING documents all
materials used in course of the production process. At the time of input, the system
identifies and verifies the input materials using the connected barcode readers or transponders.
In combination with the material flow control component of PAS-X, it
also enables control of all material transports with integrated
container management and facilitates integration with Automatic Guided Vehicles (AGVs) or pallet handling systems.
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| Audit Trail |
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Electronic data that is produced during execution on the shop floor (Electronic Records and Electronic Signatures) is documented in accordance
with the requirements of 21 CFR Part 11.
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| Electronic Batch Record featuring a Deviation Report |
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| The electronic batch record summarizes the data to provide it in consolidated form for easy and
effective review at a PC saving a lot of time. ELECTRONIC BATCH RECORDING also creates a separate report on deviations.
At a single glance, the persons in charge can grasp and assess all information relevant to approval or rejection.
The approval workflow can be configured in a flexible fashion and define several persons and departments to be in charge.
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| Batch Tracking with Graphical Batch Tree |
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The batch data captured throughout the production process is placed available in
the Compliant Historian Database of PAS-X for later analysis. To enable easy access,
all pharmaceutically relevant batch data and its links to other information is arranged in
a graphical batch tree. Moreover, there are standardized search functions helping
the user to find specific batch information.
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