Late deliveries, rejects, inaccurate ASNs, failure to follow regulations, and lack of traceability lead to chaos and penalties

Compliance avoids chaos

Real-time tracking enhances your ability to control materials, manage operations, deliver on time, improve product quality and reduce risk.

Capabilities

BellHawk helps you comply with the demands of customers, standards and regulations in many ways including:

• Materials resource planning
• Materials tracking using automatic identification
• Quality assurance
• Traceability

Demand driven materials supply

For rapid responsew to customer orders the BellHawk Manufacturing Execution System (MES) has an Available Inventory Prediction module and a Demand Driven Resource Planning module.

Available Inventory Prediction

This module gives managers a real-time view of what needs to be made or ordered. In addition to physical inventory, it tracks 'virtual inventory' which is the sum total of materials on order and those to be consumed, made and shipped.

Managers can use this information to issue work orders and purchase orders. This would require a lot of tedious manual work when the order is for a product with many sub-assemblies and parts.

Demand Driven Resource Planning

This module creates purchase orders and work orders from available inventory predictions. This saves a lot of tedious manual work, especially when the orders are for a product with many sub-assemblies and parts.

BellHawk gives users the option to make or purchase each ship order line item. When they choose to make an item the bill of materials (BOM) appears with an option to purchase or make each part at each level. This carries on until only items to be purchased remain.

Material Tracking

BellHawk prevents the use of incorrect materials and shipment of the wrong products.

Validation at every step

• Part number
• Version number
• Lot number
• Serial number
• Expiration date
• QC status
• User defined attributes

Automatic Identification

Barcode tracking ensures the correct materials are used to manufacture products and the right products are shipped to customers.

Automated Labelling

BellHawk automates label printing by applying predefined rules for selecting the label format and the data to be printed. These eliminate human error and ensure all materials, products and packaging are correctly labelled.

Quality Control

BellHawk materials tracking and labelling systems stop people using the wrong materials and shipping incorrect products.

The main purposes of the Quality Control module are to:

1. Prevent the use of defective materials and shipment of substandard products.
2. Build a record of all inspections of materials to prove quality control requirements were followed.

The module also provides status and inspection information for the material traceability module (TRACE).

QC inspection

The QC module provides full and statistical inspection.

Statistical inspection allows you to approve a whole lot at the same time. When a sample fails you can flag all the containers of the lot as failed or needing individual inspection.

QC status

The QC module tracks the status of batches of materials and products in containers and serially numbered items:

• Passed.
• Needs inspecting (100%, statistical).
• Failed (with reason code).
• Requires Material Review Board (MRB).
• User Defined states.

QC warnings

The QC module will warn handlers and operators who attempt to move, use or pick materials that have not passed inpection.

QC management

QC departments can see the location of materials waiting for inspection on a PC screen. Qualified staff can then go and inspect the containers or, in some cases, release them.

GMP · FDA compliance

BellHawk meets the requirements for material tracking and traceability in regulated industries such as food, medicines and life sciences, and others concerned with human health and safety.

BellHawk designed the system to comply with FDA 21 CFR Part 11 regulations for software compliance. It is thus an implementation of the guideline in the European Commission GMP, Medicinal Products for Human and Veterinary Use, Annex 11 for closed computerised systems.

Traceability

The Materials Traceability (TRACE) module implements rapid lot and serial number traceability. This meets the requirements in international standards for quality and safety management.

Track · Trace

The module accesses the BellHawk materials tracking database to provide one-step-forward and one-step-back traceability.

Users can trace back from a suspect product to materials and forward from defective materials to the affected products and shipments.

Risk reduction

BellHawk's methods of tracking lots and containers help to minimise the impact of recalls including risks of legal action and draconian penalties.

Industrial applications

The materials traceability module (TRACE) is a cost effective solution for:

• Aerospace and automotive component suppliers,
• Food processors,
• Pharmaceutical companies,
• Life sciences organisations,
• Manufacturers of products with a potential impact on human safety.

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