Manufacturing Applications eXperts, Inc -Operation Management Solutions

 Pharmaceutical Products & Services

Manufacturing Applications eXperts, Inc. – Our Solutions

Manufacturing Applications eXperts, Inc. offer the following solutions:

• MAX Freezer Tracking
• MAX Materials Manager
• Environmental Data Manager
• Residuals Materials Tracking
• Plant Information Intranet (PII)
• ABC Inventory Cycle Count System
• Container Tracking System
• Equipment Log Book System
• Downtime Tracking System
• Warehouse Lot Management
• Calibration-Qualification

For a detailed description of each solution please click the solution's title above or scroll down.

Easily Track the Location and Movement of Sample Plates and Tubes Across Multiple Freezers in Multiple Locations

MAX’s Freezer Tracking acts as a “GPS” for sample freezers. In this barcode-based solution, a portable scanner provides a very efficient and user-friendly interface that allows the lab personnel to visually navigate through the storage system to perform check-outs, check-ins, moves, and inventory. Throughout any activity, the details of plate and tube location is tracked and easily viewed via a browser on any desktop. The result is improved productivity in plate and tube management along with up-to-date, accurate location and movement information for all your sample plates and tubes.

• Track and manage the location and movement of plates and tubes across multiple freezers in multiple locations
• Track plates and tubes by site, freezer bank, freezer, rack, box, rack slot, and box slot
• Portable scanner provides visual navigation of the storage system to enable locating the proper plate or tube with a few clicks
• Perform both planned and adhoc check-outs and check-ins as well as moves and inventory
• Inventory plates and tubes by simply scanning barcodes - location information automatically updated by inventory results
• Web-based interface allows you to view the hierarchy of your freezer storage and drill down to the details of each plate or tube
• Designed to track sample library information or to integrate with existing library tracking systems
• Optional Web based reporting lets you provide extensive reporting and analysis information to any browser
• Meets the requirements of 21 CFR Part 11
• Complete audit trails maintained on what changed, who made the change, and when the change occurred

Improve the Tracking and Management of Raw Materials, Intermediates, Bulk Products, or Finished Goods

MAX’s Materials Manager enables the tracking and management of materials as they are received and consumed. Whether you need to track raw materials, intermediates, bulk products, or finished goods, this barcode-based solution will improve the accuracy and efficiency of your inventory management.

A portable scanner provides a very efficient and user-friendly interface that enables you to track materials as they are received, moved, returned, disposed, or consumed. The use of a portable scanner not only ensures fast, accurate data input, but also enables tracking from anywhere in your operation. During the consumption or change in status of any material, MAX’s Materials Manager automatically updates and maintains inventory levels and location information. At the same time it tracks who, when, and what activity was performed. The result is improved productivity in inventory management along with accurate inventory levels, inventory locations and a complete activity history.

• Track raw materials, intermediates, bulk products, or finished goods
• Track materials as they are moved, returned, disposed, or consumed
• Track materials from anywhere inside your operation and across multiple locations with the integrated, portable barcode scanner
• Track materials by item number (part number, product code, etc.),
  by vendor lot number, or by internally generated lot number
• Track key biographical information for each material including material status
• Automatically updates and maintains inventory levels for all materials as they are received, consumed, disposed, or returned
• Track actual inventory level against target level, reorder point and alarm point
• Integrated barcode printing automatically creates material labels at receiving
• Built-in reports show the inventory levels, locations, and activity history for each material as well as who, when and what activities were performed
• Meets the requirements of 21 CFR Part 11 for FDA regulated industries

Automate Your Environmental Monitoring Process while Improving Data Collection, Analysis and Reporting

In Pharmaceutical cleanrooms, environmental monitoring can be a time consuming and resource intensive function. MAX Environmental Data Manager (EDM) provides a solution that automates the setup, collection, analysis and reporting of particle monitoring data.

EDM is a portable solution that allows you to collect and analyze data directly from a particle counter at any sample point. By collecting the sample results directly into a portable data collection unit, the need for data transcription from paper tape is eliminated. This improves the accuracy of the data and streamlines the collection process. At the same time, EDM instantaneously analyzes sample results to determine any out-of-spec conditions and automatically sends out deviation notifications. All results are stored in a central database where built-in reports enable further analysis and compliance reporting. MAX EDM results in a more accurate and efficient monitoring process that meets regulatory requirements while reducing the overall cost of monitoring.

• Key setup data, such as particle counter calibration info, is collected by simply scanning barcodes
• Built-in scheduling notifies the appropriate individual when samples need to be taken
• Your unique operational steps for collecting samples are defined and used to provide a
  menu-driven interface that leads the operator through the collection process
• Sample results are collected directly from a MET One particle counter into an intelligent, portable data collection unit
• Automated sample result collection eliminates transcription errors, streamlines the collection process, and eliminates the reliance on paper tape
• Portable data collection unit allows you to collect and analyze data from any sample point
• Out-of-spec conditions result in automatic alarm notifications to the operator, email notification to designated individuals, and logging to the central database
• All results are stored in a central database for further analysis and compliance reporting
• Optional Web-based reporting available
• Integrated barcode printing allows you to print sample labels on a portable printer for labeling physical samples
• EDM can operate wirelessly or in batch mode - as a wireless solution, sample results from the cleanroom are available for analysis and reporting in real-time
• EDM meets the requirements of 21 CFR Part 11
• EDM is offered with standard installation and operations qualification to streamline installation and validation efforts

Residual Tracking System includes:

• Bar - Code Scanners for fast data entry
• User friendly PC interface for manual transaction, error correction and reports
• Robust database for data storage

Features:

• Turn Key Solution to Paper based systems
• Minimum of Manual Data Entry
• Reports
• Multiple functional users

Plant Information Intranet (PII) is an Intranet Browser-based viewing real-time plant information system for manufacturing plants. With PII, plant personnel have the power to solve problems and complete analysis. They can also determine the status of equipment, tests or batches from their desktops by accessing an easy-to-navigate, real-time plant information system driven by operation data through Smart Web Pages.

The objective is to provide a system, with a thin/easy-to-maintain desktop. The desktop is limited to a Netscape or Microsoft browser

The Inventory Cycle Count solution enables an ABC based Cycle Count to validate the status of inventory systems. Materials are classified into A, B, or C class based on value and volume and are reconciled against the ERP/MRP inventory tracking system. The solution can be used to reconcile raw materials, packaging, or product inventory. The system schedules each item to be counted annually, semi annually, or quarterly.

• Schedules inventory counts by item code
• Produces count lists
• Automatic backlog of uncounted items
• Ability to select item for recount
• Produces reports for monitoring and corrections
• Interfaces with existing ERP/MRP or other inventory systems
• Integrated Barcode Scanner for fast remote data entry of counting activities
• Optional web-based reporting
• Meets the requirements of 21 CFR Part 11

MAX’s Container Tracker replaces paper-based methods of tracking with an efficient barcode based solution. FDA regulated industries can now easily track and manage all critical activities of individual containers and pallets in manufacturing and warehouse operations.

The result is up-to-date, accurate tracking information that meets regulatory requirements. At the same time, the improved effectiveness of this solution will help reduce the overall cost of tracking.

MAX's Container Tracker Integrates a Portable Symbol SPT Barcode Scanner for Data Collection, with a Robust PC application that Allows you to Log, Track and Manage Container and Pallet Activities.

LogBook provides online maintenance tracking for pharmaceutical companies without the headache.

Tracking maintenance activities has taken on a new importance, with stricter regulatory requirements and operations being expected to perform more than ever. Operation professionals need to be able to pinpoint what task was performed when- many times at a moment’s notice. And regulatory agencies need more than just the data. Data must be assembled for presentation, often with each agency requiring reports in their own specific format.

Online maintenance tracking systems offer considerable benefits over paper-based records and they are quickly becoming a necessity for operations of the 21st century. Paper records take too long to search and are simply insufficient for users that need to access maintenance data from other parts of the operation and different company sites. More than that, paper records don’t allow users to access current data- a necessity.

LogBook gives pharmaceutical operations the means to stay on schedule and produce real-time reports in various formats. Professionals use scanners to record maintenance activity as it occurs. The scanners transmit data back to the information system. With proper password, users can access current data from any computer equipped with a Web browser.

Downtime Tracking improves the operational yield and efficiency of manufacturing lines by tracking the downtime cause, duration, frequency, product equipment and operations personnel. Downtime details are entered via portable integrated Symbol SPT scanners, at the site of the downtime, to ensure accuracy. PC or optional web based data analysis is used to identify causes of downtime.

MAX’s Warehouse Lot Management allows you to track and manage the complete cycle of product lots in the warehouse from receipt to shipment. The solution replaces ineffective paper-based systems with a portable barcode-based solution that ensures up-to-date, accurate lot information is maintained.

Whether your lots are comprised of pallets, cases or other units, each is individually labeled and tracked as it moves through the warehouse system. By tracking all the activities of each pallet in each lot, Warehouse Lot Management helps you maintain lot integrity. At the same time, you can now easily track the status of all product lots currently in process in the warehouse. This includes understanding which pallets have been received for each lot, whether the lot has been released, and which pallets are still in the warehouse. The result is improved warehouse operations through more effective and efficient lot management.

Tracking the life of operation instruments and managing equipment life-cycle records

MAX’s Calibration-Qualification System records the activities of the instruments that run an operation. It organizes instrument activity data and produces quality Instrument Master Records.

From every wheel and tank to each small valve, an operation’s instruments must all be up to performance. Operation professionals need to know what instruments can handle and must have easy access to data such as temperature sensor ranges and scale limits. They also need to have instrument history close by- even before arriving for installation or while temporarily out of the operation’s possession.

Not knowing this information is certain to lead to bad decisions and cost time and money later. But with countless parts and pieces, this information is difficult to track. Even more painstaking is compiling this data into legible reports for employees and regulatory authorities.

The Calibration-Qualification System starts tracking equipment before installation and continues on through the operation life. It provides full details on receipts, inspections and calibrations by external contractors. The system uses handheld scanners in the warehouse and external scanners to track activities outside the physical plant. Scanners transmit data back to the information system. With proper password, users can access current data from any computer equipped with a Web browser.

For more information about any of our solutions please visit our website.

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	Manufacturing Applications eXperts, Inc.
	840 Main Street Suite 206 Millis, Massachusetts 02054 USA
Tel.	+1 508 376 2277
Fax	+1 708 810 3163