Batch Reporting; Introduction; Launching The Report Client Application - Merck Millipore Mobius Chrom 20 System User Manual

Mobius Chrom 20 System with Flexware
®

Batch Reporting

Introduction

The CCP system provides the collection, storage, processing and reporting of batch
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production data, in accordance with international standards on batch control and current good
manufacturing practices.
All recorded information pertaining to a batch is referred to as the batch history. CCP
stores the batch history so that it is associated with the actual execution of the applied
bioreactor protocol.
Batch specific information contained in the batch history includes:
• A copy of the actual protocol used to perform the process. It includes any changes made
during the execution. This is basically event data including:
• Predictable events: Certain event data are logged during the execution of the operation.
Predictable events include start/stop times of procedural elements.
• Unpredictable events: Any non-programmed operator intervention is logged, such as
comments based on observations during system operation, entry of any results, sampling,
etc. The log includes intervention type and user ID. Other unpredictable events logged are
alarms, equipment failures or other abnormal conditions.
• Trends of measured process parameters such as temperature, pressure, etc.
• The event log for setpoint changes for controllers and peristaltic pumps when PID controller
is disabled.

Launching the Report Client Application

To launch the CCP Report Client application, which is used for batch reporting, click the Reports
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icon in the tool bar.
Report Client - Tool Bar
The functionality of the icons in the Recipe Editor Toolbar is described below.
Icon
Assemblies
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Open an existing report
Open the report generator
Exit the report client
Open the verify tamper proof signature window
Switch between the keyboard mode or the touch screen mode
Description
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software
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