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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 provides user-friendly, standardized operating dialogs throughout the whole production process - from receiving incoming goods, to production, to packaging, and including the shipping of finished products. Its 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 basic functions 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
special workplace-related dialogs PAS-X finally ensures intuitive and ergonomic working for
the user.
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| Workplace Concept |
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During the execution of electronic batch records, PAS-X provides different workplace-optimized user
interfaces and dialogs specific to a user group's role in the production process following the
workplace concept. Various types of user interfaces are
available for this purpose:
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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 basic functions 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 used to control the process. In this case, the workplace concept of PAS-X offers integrated visualization of electronic basic functions and process data. This way, the user obtains a homogenous picture of the process state.
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| Integration of Equipment |
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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.
The Compliant Historian Database of PAS-X places the data captured available for further analysis purposes (
MANUFACTURING INTELLIGENCE).
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| Deviation Handling |
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During execution on shop floor,
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 of
the PAS-X form a solid foundation for comprehensive deviation management.
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| Control of Material Flow |
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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 attached barcodes or, rather,
transponders.
In combination with the material flow control component of PAS-X, it
also enables control of all material transports with integrated
container management, for example to be integrated into 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 shop floor (Electronic Records and Electronic Signatures) is documented in the Compliant Historian Database in accordance with the requirements of 21 CFR Part 11.
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| Electronic Batch Record incl. 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 workplace saving a lot of time. ELECTRONIC BATCH RECORDING
also creates a separate report on deviations. At a single glance, the tasked associates can
grasp and assess all information relevant to approval or rejection. The approval workflow
supports flexible configuration of multiple persons and departments to be in charge.
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| Batch Tracking with Graphic Batch Tree |
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The batch data captured in the production process is placed available in the Compliant
Historian Database of PAS-X for later analysis. To provide easy access, all pharmaceutically
relevant batch data and its links to other data is arranged in a graphical batch tree. Moreover,
there are standardized search functions to assist in finding specific batch information.
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