As a major pharmaceutical operation in the manufacturing process of all formulations, the line clearance is essential to ensure the quality of pharmaceuticals products and patient safety. Risks related to this operation are critical, and its control is therefore essential to prevent cross contamination risks resulting in rework operations or batch recall. In current economic context, pharmaceutical companies must adapt themselves while ensuring a perfect control of their processes.
The electronic line clearance simplifies operations by providing visual aids on checks, and ensures that the controls were physically carried out.
An innovative tool, developed in partnership between Schering-Plough laboratories and Editag, a French company specialized in RFID security and industrial traceability solutions, ensures full traceability of line clearance (who, what, when, where, how) and statistical data collection. Integrated to the processes and information systems, this computer assisted electronic line clearance management tool provides user authentication and allows certification levels management during completion of these controls. Security and confidence levels of the line clearance process are dramatically increased.
Based on a robust and proven technology, the system consists in a client-server software application fully integrated within the existing information system. Accessible from any PC client connected on the enterprise network, this application communicates with RFID portable terminals provided to operators.
Specific production equipment and work area control points are materialized by the presence of tiny RFID tags with a unique code. These tags are identified using portable terminals and grant operator real control actions at this point.
The terminal provides the operator with specific control area information by displaying critical information in order to ensure a successful control execution, (name of the line, machine name, and location of item to be inspected) and displays a photo of the area.
Additional comments are gathered in the database. All data are then propagated back to the server that generates a report in order to guarantee line clearance process completeness.
Thus, Computer assisted line clearance process appears as a must for a complete traceability.
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| | Monday, July 27th 2009 |  |
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