Modules

Overview

Ci-DMS receives production data from a level 4 enterprise integration system (ERP) and uses the work instructions defined for each batch to step through the manufacturing process. Data is captured either from operators or from hardware. The ERP system is updated with production performance and stock consumption information at appropriate points during the process.

ERP Gateway

The ERP Gateway is a fully configurable module that provides connectivity for the transfer of data between Ci-DMS and an ERP system in real time. Typically item, stock and order information is transferred from the ERP to Ci-DMS and stock consumption and batch status information transferred from Ci-DMS to the ERP. All data is validated and error notification is made (e.g. via email) if a transaction is invalid. All transactions are also recorded in the audit trail.

Supervisory

The Supervisory provides a means to configure the system (e.g. Rules, Resources, ESIG’s and Access Rights). It is also used to carry out daily operational tasks (including recipe approval, scheduling, resource management, remote approvals, batch release and audit trail analysis).

Process Designer

The Process Designer provides facilities to design recipe formulas and work instructions and the other manufacturing/packaging processes required at a pharmaceutical site. It offers a wide range of features to enable quick definition of the processes including templates for re-use of standard operations. All processes are maintained under version control and require approval before they can be used.

Weigh & Dispense

The Weigh & Dispense module controls the dispensing of raw and packaging materials required for batch manufacture. The operator uses a barcode scanner to interact with the system and Ci-DMS also interfaces with weigh scales and label printers. Ci-DMS ensures that the correct quantity of each material lot is dispensed. Campaign weighing (by product or material), potency and density adjustments are also supported. Electronic Signatures are used to ensure regulatory compliance.

Batch Execution

The Batch Execution module steps the operator through the electronic work instructions that have been defined for the batch being manufactured. Typically the operator will use a handheld device to interact with the system (although this depends on the environment). Data can be recorded via operator input, scanner or hardware interface. All data entry is validated and significant actions require confirmation by electronic signature. Equipment that is not clean is prevented from being used. Comments and deviations can be recorded against any action.

Manufacturing Information

The Manufacturing Information module consists of reports and dashboards. All information stored within Ci-DMS may be reported on (with drill-down functionality where applicable). All reports may be saved in Excel and PDF format. Batch related reports can be configured to require an electronic signature to generate them and are also number controlled. The dashboards display current live production data (mainly batch related). They are user definable and can display information in tabular and graphical format.

 Automation Gateway

The Automation Gateway module enables Ci-DMS to capture batch data from level 1 and level 2 enterprise integration hardware devices. These devices range from scales and scanners to more complex devices such as silo loss in weight feeders, IBC’s mounted on tracks and the locks on process vessel lids. Interfaces supported include RS232, Ethernet, Bluetooth, Signal I/O and OPC.

Call us today on +44 (0)1722 424 100 to discuss how you can dramatically reduce time to sign off batches, save money and transform your manufacturing operations. Or email your enquiry to: sales@ciprecision.com