A FULL SOLUTION FOR DISPENSING. BECAUSE EXACT QUANTITY COUNTS.
The AX for Pharma Dispensing module provides manufacturers with a high level of control and visibility of work-in-progress materials in GxP environments.
Precisely weighing and dispensing materials is so important in pharmaceutical production that it is still delivered in most cases with highly manual operations under very severe supervision and controls. Consider the delicate task of manually entering paper documents in the dispensing list. You must enter materials, batches, containers, and quantities, and then re-enter this information in the ERP solution to adjust your inventory. Needless to say, the risks involved in handling these operations manually and the relevant costs, including supervision, are very high.
The general trend today, however, is to rely more and more on powerful IT instruments to achieve lower costs, deeper control, and greater accuracy in weighing operations. One of the best options is to integrate the weigh and dispense operations in the ERP solution with precise rules. This integration provides important benefits: the ability to use a wealth of information instantaneously, ensure the best production outcome, reduce risks, and lower the total cost of validation.
You can secure those benefits with the fully integrated AX for Pharma solution. The Dispensing module enables you to connect scales to the ERP production and inventory modules, and it calculates the required quantities of active ingredients and fillers/compensating ingredients to be used. The full integration into ERP also allows the selection of materials according to the FEFO/FIFO method.
As soon as the dispensing operator scans the barcode label of the container being weighed, the dispensing module verifies the batch status, availability and expiry date, thus preventing the use of non-conformant or expired batch-es in production. The weight registered by the scale is immediately recorded in the production-picking list for consumption, with inventory adjustments in case the actual weighed quantity differs from the theoretical one.
See more details in the benefits tab below.
Efficiency and effectiveness
The AX for Pharma Dispensing Module provides for global and material-specific processing rules to ensure that all Standard Operating Procedures are followed. The module can provide all the information necessary to resolve issues like potency adjustment, scale requirements of the weighing area, weighing tolerances, operator training needs, MSDS and SOP reference links, material hazard warning messages, personal protective equipment requirements, suggested container size and quantity, and weigh-scale calibration requirements and more in addition.
Fully Controlled Dispensing Made Easy
The AX for Pharma Dispensing module significantly reduces the risk of errors caused by manual and paper-intensive systems. With the support for electronic weigh-scale interfaces and extensive use of bar code labeling technology, the right material is delivered to manufacturing on time in the correct quantity, with the right packaging and label. The Dispensing module determines the availability and suitability of scales for a specific weighing operation, taking into account the results of scale calibration tests, the capacity and precision of the scale, to ensure full compliance throughout the dispensing process. The integration within the ERP allows for the automatic generation of the proposed batches to be weighed in FEFO/FIFO logic and to update your inventory instantaneously according to weighed quantities. Checks for control are simplified, including the elimination of manual reconciliations that are most always needed when using a third-party Dispensing solution interfaced with the ERP.
The AX for Pharma Dispensing Module manages the movement and control of all the dispensing batches and sub batches (e.g. containers, drums, IBCs, etc.). Material to be dispensed is checked in real time to prevent the inadvertent usage and consumption of incorrect, expired, or rejected materials.
The AX for Pharma Dispensing Module is fully compliant with 21 CFR Part 11. The module can be configured to secure critical operations with electronic signature and keep evidence of history of the actions and approvals. It enables quick review and approval of materials with electronic signature verification.
- Define the list of components to collect in the dispensing area.
- Adjust for each component the accepted tolerance.
- Control tolerance during the dispensing process and generate automatic adjustments in inventory, without any need of reconciliation.
Batch order management
- Reserve multiple batches and sub batches to move to the dispensing area.
- Release a batch order to the dispensing area.
- Manage actual quantity of components to be weighed.
- Manage additional quantity/sub-batch of a component to be weighed.
- Consume the quantity of weighed components automatically or manually, depending on system configuration, to ensure enforcement of Standard Operating Procedures and balance risks and speed of the weighing process.
- Operate scale information and interface scales directly with the AX for Pharma solution.
- Define the right scale for a component based on the scale's precision.
- Manage the status of scales (available, unavailable, calibrated, etc.).
- Launch calibration tests for scales and define the frequency of tests.
- Interface the AX for Pharma solution with barcode readers to facilitate data entry and ensure compliance with 21 CFR Part 11.
- Lead dispensing operators through the weighing process of components.
- Check the correctness of the information, e.g. item number, batch (number, status and expiry date), sub batch (number, status).
- Handle tare, net weight and gross weight and receive them directly from scales.
- Ensure usage of the allowed quantity of components and prevent operators from weighing unapproved quantities.
- Identify errors in real-time.
- Analyze error causes, report them, and resolve them promptly, maintain full traceability of the process.
- Notify designated users if a specific error occurs by using configurable alerts, workflows and reports.
21 CFR Part 11
- Require electronic signature for critical operations.
- Track the history of any batch order and linked batches and sub-batches.
- Configure security and user roles and permissions.
- Print reconciliation reports.
- Print usage reports.
- Issue production cost reports.
- Print the Master Batch Record.
AX for Pharma Fact Sheets
AX for Pharma Fact Sheet
Advanced Quality Management Fact Sheet
GMP Plant Maintenance Fact Sheet
Dispensing Module Fact Sheet
AX for Pharma is supported with a variety of insightful documents on pharmaceutical production and validation. To view our extensive resource library, simply follow the link below.
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