17 Reasons Why QAD is a Good Choice for Life Science Companies
by Don Lindsey
Several years ago at a conference, I was talking to a colleague who was in the process of choosing the right ERP system for his life science company. He asked me to list the reasons why the life science company where I was employed at the time had chosen QAD and how it was working for us.
We also used 32 Soft’s solutions for QAD to help manage QAD data and improve productivity and efficiency. 32 Soft Data Loaders allow you to download QAD into Excel-based spreadsheets where you can more easily view and manage details before uploading changes right back to QAD. Data Loaders verify data using genuine QAD logic prior to the upload to ensure your data is error-free.
Here are my 17 reasons why QAD is an excellent choice for life science companies along with ways that 32 Soft products enhance QAD in the life science arena.
The Regulatory Compliance Module
Whether it is part of a formulation or an actual independent component of a more extensive system, a life science product regulated by the FDA, by its very nature, needs to trace the use and source of the various components that make it up.
QAD’s Compliance or Regulatory Control module allows you to manage lot or serial number processes which are endemic in the life science arena. The implementation of QAD’s compliance module gives one tight control over lot/serial assignment, the ability to assign an assay % or characteristic, receipt status, unique expiration dates, batch processing and lot group auto number assignment. Lot where used and actual lot bill reporting provide complete traceability from supplier receipt to shipment and gives the ability to source back to those same supplier components, if the serial or lot number of the product is known, as might be required in a recall situation.
There are several Data Loaders from 32 Soft that will help manage lot/serial data. Item Master Data Loader gives a quick and easy way to manage your item master details and is a great implementation tool, as it enables you to load item records into QAD rapidly and accurately. If you have a large number of item site inventory records to keep updated, 32 Soft’s Item Site Inventory Data Loader will speed up the process. Inventory Transfer Data Loader gives you an easy-to-use way to manage the transfer of inventory from location to location and Work Order Maintenance Data Loader helps you maximize your work order process.
Formulas and Bills of Material
The basis of all ERP/MRP systems is the ability to define what makes up a product or assembly. From the early development of the BOMP (Bill of Material Process) by IBM in the late 1960s to the development of Material Requirements Planning by Olivier Wight and George Plossl, the BOM has been and always will be the foundation of ERP. QAD allows both the assignment of classic Bill of Material parent – component relationships with standard quantity per for assembly of kits and subassemblies. But, the system also allows the use of formula functionality in which one can set a per batch or a percentage of batch quantity along with potency and multiple units of measure conversion processes to assist in the planning and manufacture of a mixture of different components.
32 Soft’s Product Structure (BOM and Formula) Data Loader helps significantly boost your productivity by massively managing your product structures and replacing the need to update one record at a time manually.
The Quality Management Module
Quality Control is an absolute requirement for Life Science companies, and QAD’s Quality module gives you everything you need to document and control the quality aspects of a product or component—from risk assessment to the production part approval process to advanced product quality planning (or APQP). You can create master specifications and the individual item specifications from those masters in QAD as well as create the quality process definitions which indicate how the quality work order should proceed. Plus, QAD gives you the additional ability to define receiving-oriented quality work orders and lets you include those specifications and process routings into either standard work orders or independent quality orders. You can also print Certificates of Compliance for your products.
Advanced Repetitive
In most manufacturing environments a discrete work order (part number-qty-date) is the most common method of creating the documentation and recording the activities of fabrication. In the life science industry, especially in the manufacture of mixtures or solutions, discrete work orders are cumbersome and require too many issues and receipt transactions. QAD’s Advanced Repetitive module gives a much more efficient method of recording the creation of a period-based schedule and the recording of the consumption (backflushing) of components along with their cost/lot control method. You can create a schedule based on part number/rate per period as opposed to creating individual discrete work orders based on part numbers/quantities/dates.
With 32 Soft’s Production Planner for Advanced Repetitive Data Loader, you can create, update and explode production schedules directly in Excel using real-time QAD data, run what-if capacity reports, review resources and capacity requirements, and much more.
Process Definitions
As opposed to standard routings used for discrete work order, QAD allows for the creation of routings based on runtime/batch quantity along with yield calculations for cost and CRP (Capacity Requirements Planning).
The Routing Maintenance Data Loader helps you to manage QAD routing records using familiar Excel spreadsheets and significantly reduces the time it takes to manage routing details.
MRP Material Requirements Planning
Since the 1960’s MRP has become the primary method of planning and scheduling orders in a manufacturing environment and QAD is built on the APICS Body of Knowledge with regards to MRP netting logic. QAD and MRP function at optimum only when all planning elements and planner knowledge are coupled with BOM and On Hand accuracy.
Lot/Serial data for MRP can be updated in a number of 32 Soft’s Data Loaders.
Capacity Requirements Planning
With the correct calculation of MRP, the proper definition of departments, work centers, and accurate routings, QAD gives the user a complete picture of the capacity required to produce the plan. Not only that, it gives the ability to balance load and capacity with over and under capacity constraints. Remember: A plan that exceeds capacity will not get built and will only build inventory.
Global Requisition System
In a life science FDA-controlled environment, tight management of the procurement cycle and Suppliers/Vendors is critical. How your company organizes its approval process will define this crucial aspect of any life science company. QAD’s Global Requisition System gives your organization complete review and approval options at all levels—horizontally, vertically, by job/project or category. The ability to attach documents to requisitions and purchase orders increases control and communication between the purchasing department and all their suppliers.
32 Soft’s Requisition Plus portal is an independent stand-alone system that gives both QAD users and non-users access to select QAD data—so even non-QAD users can approve and route purchase requests. It has a feature which allows buyers to create purchase orders right from their smartphones and uses a CIM interface to integrate with QAD to ensure data integrity.
Security
After several corporate financial scandals including Enron, Arthur Anderson, and WorldCom, Congress passed the Sarbanes–Oxley Act of 2002. SOX compliance is as essential in publicly held companies as compliance is to FDA in life science companies. With the Entity, Site, Menu and Field security, QAD ensures that only authorized individuals can make changes across all levels of operations. With the additional functionality of the enhanced audit table, electronic signature and SOD (separation of duties) reporting, QAD’s Security locks down all data in the system.
32 Soft’s Access Security Data Loader allows you to analyze and audit security settings clearly and effectively manage areas of QAD security that are important for SOX and FDA audits and compliance.
Data Load
In an FDA environment, there are several functions which are not typically controlled through the ERP system. PLM (Production Life Cycle Management) and documentation systems are just two examples. Interfacing your ERP to these critical applications can be accomplished either through a simple screen duplication process called a CIM Load or through a more sophisticated function that operates as a true API with scheduling, filters, and Boolean logic. Additionally, QAD has a direct built-in export and import functionality to Microsoft Excel.
32 Soft’s Auto Load is another interface which can be used to load data to your QAD system. Auto Load is designed to accept text format documents and deposit them onto your server. Once on the server, the interface automatically begins loading your data files into your QAD system.
Modifiable Screens
To control who does what to what data, screens in the QAD system are entirely configurable to meet your needs. You can default fields, require fields and add fields to the database—all by user control without costly IT intervention.
Easy Data Access / Browses – Report Net
Reporting the various aspects of production, sales, purchases and quality activity can be a daunting task. With access like browses and the new Report Net reporting structure, enhanced output capability, reports, ad hoc quires, and sophisticated output are within the standard functions of QAD—without the cost of outside applications.
WIP Lot Trace
If internal work order or process lot controls are required in your medical environment, QAD offers the capability to assign lot numbers to individual components and to track those components through the entire manufacturing process using the WIP Lot Trace Module.
Supplier Performance
In an FDA environment, your suppliers are your lifeblood. QAD offers a complete Supplier Performance module based on user-defined criteria such as delivery, date compliance, and quality measures. With this module, you can build and maintain vendor relationships which will ensure your continued success in the supplier community. If you desire a direct interface to your supplier community, QAD’s supplier portal allows a straightforward way that suppliers can pick up their schedules and requirements and submit invoices for payment online.
There are a number of Data Loaders that can help you manage the details of your suppliers, the items you purchase from them and your order schedules:
Supplier Scheduled Order Data Loader
Supplier Maintenance Data Loader
Supplier Item Maintenance Data Loader
Service and Support
For companies that produce both hardware components and fluid or chemical components, QAD offers a complete cadre of functions including Call Management, Installed Base functions, Field Service Engineer Scheduling, Contract and Warranties Management, RMA (Return Material Authorization) RTS (Return to Supplier) functions, and Material Orders for Field functions in QAD’s Service and Support Module’s.
Product Change Control
In any medical organization, the product, processes, and people are in a constant state of change and improvement. The Product Change Control module puts the necessary change process under user control to ensure that changes happen only under valid conditions with the appropriate sign-off.
32 Soft’s Product Change Control Data Loader simplifies product change order entry and makes it easy to view changes to product structures. You can also coordinate changes to multiple product structures that have common components with this tool. Plus, Product Change Control gives you an automatic audit trail of product changes in QAD.
Enhanced Controls Module
In an FDA environment, it is essential to trace which user or individual made changes to such critical data elements as PO data, Item Master data, BOM and Formula relationships. The quality audit capability of the Enhance Controls Module tracks these changes automatically. You can also use Enhanced Controls to ensure electronic signature approval of work order processing, quality actions, purchase order placement or anything that requires multiple signatures for compliance.
Based on a thorough review of the above with my friend, I am pleased to say that he and his team went through the standard ERP selection process, and ultimately chose QAD as their ERP system.
“Give me six hours to chop down a tree, and I will spend the first four sharpening the axe.” —Abraham Lincoln
Don Lindsey, CFPIM, CIRM is a knowledgeable Implementation Project Manager, Trainer and Business Analyst for all areas of QAD. He has been an implementation manager on several large, complex MFG/PRO projects, and has worked with the QAD system since 2007 in Manufacturing, Systems Management, Service & Support, and Finance. Don has a diversified background in a wide variety of manufacturing industries from Medical to Electronics to Industrial to Consumer Products. He has spoken for many years at the APICS Conferences, having taught in the APIC Certification program at California State University @ Fullerton for more than 20 years.
Need a better understanding of MRP or training for your staff? Don is available for training and consultation. You can reach him at dhl@32soft.com
