Medical Device Industryadmin2017-08-29T19:05:27+00:00
SYSPRO for Medical Devices is designed to assist this highly regulated and specialized industry in developing, marketing and distributing devices that will surpass evolving medical technology and avoid obsolescence, while controlling medical liability and other costs.
SYSPRO’s applications enable electronic collaboration in the design and marketing of new products, and will track material movement throughout the supply chain, simplifying safety and health compliance and lowering costs in clinical trials.
Whether your company is a manufacturer or distributor of medical devices, SYSPRO offers a framework for price setting and analysis. Our innovative solutions will help your company to meet essential quality, safety and profitability requirements.
Whether a compliance-critical requirement, or an analysis tool for continuous improvement strategies, the traceability of products from material origins through manufacture to final destination, is a key system requirement in medical device manufacturing.
SYSPRO facilitates the recording of traceability and quality data on materials and products from purchasing through inspection, manufacturing, manufacturing inspection, stocking and sales. The recording of expiry and shelf-life information is also facilitated and powerful queries enable both upward and downward searches by stock code, lot number and transaction type.
SYSPRO’s lot traceability and serial tracking functionality afford full visibility to the origins, build and customer destination of products and batches, thereby providing the means to easily trace and analyse the source of defects, should they occur. In addition, SYSPRO’s Engineering Change Control module enables complete management and traceability of changes to product designs, while the Return Merchandise Authority module provide consistent handling of product returns, as well as analysis data for improvement programs.
Improve Electronic Collaboration with Trading Partners
Quick response times and accuracy in fulfilling orders are critical to your reputation in a diverse and demanding global market. Your larger customers and suppliers may look increasingly to closer collaboration to cut production timetables and minimize disruption to their supply chain. This could involve working via their electronic order and supply chain systems, to enable streamlining of operations and to reduce margin for error. To achieve this, you must have adequate systems that can deliver information efficiently between you and your trading partners.
SYSPRO facilitates streamlined, secure electronic data interchange and collaborative commerce through features such as CAD integration, Document Flow Manager, SYSPRO e.net solutions, EDI, Office Automation and Messaging, and various Business-to-Business purchase and sales import and export functions.
Compiling, Storing and Retrieving Certificates of Conformance
For a purchased item, you can link an electronic copy of the supplier’s certificate of conformance to the relevant lot numbers (batches) for the item, using SYSPRO’s multimedia capabilities. You can then view the certificate against a lot when querying the lot and processing transactions, such as job issues, sales or transfers.
Constant innovation is one of the key factors to remaining competitive and on-going research and development to design new and better products is integral to the industry. Your ability to design new products and modify existing designs, as well as improve time-to-market is critical to remaining competitive and profitable.
SYSPRO provides tools to streamline and track the introduction of new product designs and amendments to existing designs, along with relevant costings. SYSPRO’s Engineering Change Control (ECC) enables you to apply strict control over your design-to-market processes by providing an integrated rules-based electronic workflow system with full version control, security and auditable history.
ECC gives you the tools to record and track new and modified product design and process changes, assess the impact of these changes on costs and associated data, and control the change routing and approval processes. ECC’s queries, audit trail, history and archive facilities, give you quick on-line access to details of prior product versions, as well as the option of reverting to the production of a prior product version if required. In addition, the facility to attach copies of product design drawings to version and release levels provides access to visual details of revisions.
The Where-used Query facility enables you to identify all items affected by the raising of an Engineering Change order for all routes identified as being under Engineering Change Control. In addition, SYSPRO provides a ‘replace component where-used’ facility that enables the quick replacement of one item with a valid substitute item, thereby streamlining design changes.
SYSPRO’s ECC, Bill of Materials, Work-in-Progress and Factory Documentation modules enable you to implement controls to ensure that your products are manufactured under consistent processes, to the correct designs and specifications. Single-level, multi-level, co and by-product bills are all catered for and flexible bill definitions accommodate complex component and sub-assembly requirements.
Manage Finished Product Distribution to a Number of Warehouses
In order to maintain appropriate inventory levels in a distributed warehouse environment, you must be able to plan, distribute, monitor and control inventory moving across your internal supply chain.
SYSPRO’s Goods in Transit system provides the facilities to create, manage and monitor transfers between multiple warehouses and provides complete visibility to the status and details of in-transit transactions. It gives you the tools to easily create and receipt stock transfers for each warehouse, capture transfer costs, identify and adjust exceptions as they arise and to reconcile transfers sent and received in terms of cost and quantity. The system provides a detailed financial subledger and enables easy reconciliation to SYSPRO’s General Ledger.
Used in conjunction with the SYSPRO Sales Order module, the Goods in Transit system provides functionality to record backorders in the system for multiple warehouses and to electronically produce accompanying paperwork. Additionally, using the Material Requirements Planning module, SYSPRO’s goods in transit functionality extends to Distribution Requirements Planning, thereby enabling plan production and purchasing to meet current and future distributed warehouse requirements. Order policies at stock code warehouse level accommodate different lot-sizing techniques per warehouse.
SYSPRO provides the capability for the secure storage and fast retrieval of reliable integrated information to enable quick extraction when a product or batch recall is necessary. Adherence to stringent EU/ MHRA /FDA/TGA regulations in terms of traceability and recall procedures in industries, such as food, pharmaceuticals and medical devices, is facilitated through SYSPRO’s lot traceability and serial tracking features. Multimedia capabilities enable the linking of relevant documentation and graphics to products and material, while custom forms facilitate the capture of essential traceability data relevant to your industry.
SYSPRO includes the facilities to trace items from raw material origins to customer, and vice versa, as well as the ability to identify the processor of every transaction or data change associated with the item, via Electronic Signatures. Full upward and downward searches and extraction of the integrated traceability data is provided by SYSPRO’s powerful queries, and standard or user-defined reports.
Using SYSPRO’s powerful traceability features, you can confidently identify the source of defects and quality issues, and thus limit recalls to defective product only. This prevents the need for total product recall and the associated costs and reputation impact.
Optimize Production Capacity and Increase Manufacturing Efficiency
Increasing manufacturing efficiency means getting the right balance between demand and supply, while optimizing capacity, improving throughput, and reducing waste and variable costs. SYSPRO provides interactive decision support tools that give you visibility and control over all inputs and outputs.
The Material Requirements Planning system gives you an integrated picture of your demand and supply, as well as your available capacity, enabling you to model what-if scenarios to produce viable replenishment and production plans. SYSPRO’s Factory Scheduling assists you in maintaining accurate and up-to-date production schedules that take account of the complexities of your factory. This enables better co-ordination between work centers, increases productivity, reduces work in progress and achieves better customer service levels.
Material and labor tracking, as well as cost, scrap and utilization management is facilitated through SYSPRO’s Work in Progress module, which enables you to track in-process production at every stage and identify problems as they occur.
SYSPRO enables you to implement continuous improvement by helping you to identify problems and points of waste as they happen. Raw materials and manufactured products in the industry often vary in grade and quality, so tracking and control is essential to reduce waste, scrap and defects. SYSPRO enables you to specify approved manufacturers for raw material supplies and supplier performance can easily be tracked using queries and reports. In addition, SYSPRO facilitates the tracking of materials from purchase through production to customer, thereby maximizing quality control and providing you with the tools to manage product recalls, should they occur.
You can flag purchased items as requiring inspection so that during receipting, detailed records of counts, inspection, scrap, rejects and returns is recorded. Units in inspection are visible, but unavailable for use until accepted into stock. Similarly, SYSPRO’s Work in Progress inspection system provides the tools for you to inspect manufactured product quality and, depending on the results, select to receipt, scrap or rework quantities.
Efficient management of your receivables and mitigation of bad debt is essential to maintaining a healthy cash flow. SYSPRO’s powerful features can assist you to improve your credit management performance with reduced effort, as well as to maintain single-point communications with your customers.
Extensive order and invoice credit checking features enable the implementation of flexible terms and controls to suit different categories of customer. Ageing methods offered include by invoice date, invoice due date, statement date and aged statement date and customer terms allow for a variety of settlement discount options. Multi-currency invoice and payments are catered for, as well as the automation of finance and recurring charges.
Prompt electronic delivery of customer statements, invoices and copy invoices is facilitated through SYSPRO’s email and fax integration; documents can be transmitted directly from point of extraction. User-defined stationery formats preclude the need for pre-printed stationery and enable the creation of customer documents in Word or secure PDF format. Additionally, you can enable customers to query your SYSPRO database directly for detailed account information, via the internet with SYSPRO Office Integration or SYSPRO e.net solutions.
The Average Days to Pay calculation and extensive search, query and report features enable the quick and accurate assessment and targeted follow-up of customer debt. Rapid application of customer payments against a large number of outstanding invoices is efficiently handled, including the automatic payments application feature. Also, the time and effort to manage trade customer accruals, rebates and deductions is significantly reduced through the use of SYSPRO’s Trade Promotions and master/sub account functionality.
SYSPRO helps to greatly streamline the completion of account receivable month end procedures. Creation of workflow and checklists for periodic and month-end procedures is made possible through SYSPRO’s customizable menus and Task Manager.
Furthermore, you can configure SYSPRO’s powerful event management and customization features to alert relevant personnel to certain conditions, such as accounts being overdue by a stated number of days, via email or field highlights.
The standard of service that you provide your customers makes all the difference in building solid relationships and gaining the competitive edge. This requires keeping track, not only of customer sales-related information, but also details of internal or external business relationships. To make better business decisions about expected customer, product and market activity, you need to have information in appropriate formats, and at different levels of detail, to carry out analysis.
SYSPRO’s Contact Management system caters for multiple contacts to be assigned to organizations and individuals with whom you deal. These can include your customers and suppliers, as well as entities such as charities and government departments. You can group contacts for related entities and record details regarding interactions such as phone calls, emails and visits against the contact. Integration with Microsoft Outlook allows email correspondence to be sent and updated as an activity within the Contact Management system.
SYSPRO’s Customer Relationship Management provides you with the functionality of the Contact Management System, as well as the tools to manage the track marketing campaigns, service issues, product returns, warranty and repair histories, quote and sales order information.
Your ability to deliver quality products faster, with more customer-specific features, and at stable or even reduced prices differentiates you in a discerning market place. Features such as available-to-promise and customer delivery performance reporting, provide information to help you improve your customer service levels and the Customer/stock code interchange functions gives you the flexibility to allow your customers to order by their part number.
SYSPRO enables you to keep a history of sales data as well as individual customer-related product activities, so you can easily identify buying patterns and preferences, and quickly create repeat orders by copying and amending previous ones. SYSPRO Forecasting uses sales history to identify trends and seasonal components of demand, thereby assisting you in calculating more accurate forecasts, which in turn leads to better planning and improved customer service levels.
SYSPRO’s simple, extended and contract pricing mechanisms give you flexibility to apply one-dimensional pricing and discounting, or tailor these requirements to individual customers. Where customers are large organizations, such as original equipment manufacturers (OEM) or retails chains, with whom prices are negotiated on a contract or volume basis, more complex pricing is required. SYSPRO’s pricing, trade management and sales analysis facilities enable you to provide acceptable pricing terms and delivery targets to large customers without sacrificing profitability.
Archiving provides a mechanism of storing data that would normally be delete from the system, thus enabling non-current data to be removed from day-to-day files, but to still be accessible, through the standard query programs, should the need arise. Instead of merely deleting data at the time of performing a purge routine, SYSPRO creates a file in XML format that contains the purged data. This data is stored in a pre-defined location that can be queried using the standard Query programs. Within SYSPRO, you can archive the following: Sales orders, Jobs, Engineering change control bill of materials.
Distribution requirements planning in SYSPRO is designed to optimize the movement of inventory in a multi-warehouse environment so that demands can be met effectively and efficiently without relying on excessive stock holdings. Distribution Requirements Planning provides the drivers that enable the Requirements planning module to suggest Supply Chain Transfers from one warehouse to another, rather than a purchase order on an external supplier, or a job on production. Suggestions are based on the closest warehouse in a chain of supplying warehouses, resulting in stock being supplied from oversupplied warehouses to those with a demand. A comprehensive view of the supply chain for each item is available.
Companies in either the wholesale or manufacturing sectors which have regional demand fed by one or more supply warehouses, or manufacturing plants, would typically use Distribution Requirements Planning. The integration between SYSPRO’s Inventory, Purchase Orders, Sales Orders, Bills of Materials, Work in Progress and Requirements Planning modules provides a comprehensive view up and down the supply chain.
Purchase order inspection permits predefined inspectible items to be receipted into an inspection file on receipt. Then the goods will be inspected and either accept, reject, or scrap, before updating the stock on hand.
The multi-level Trial Kitting program, is designed to check supply and demand only for materials in the Bills of Materials. It will establish which jobs need to be raised through several levels of a structure as well as the purchasing requirements required to complete the build. All sub-assemblies and components are processed, multiplying the quantity per by the net requirement of the parent. This is then compared to the net quantities on hand to determine the shortage
SYSPRO’s available-to-promise (ATP) feature helps make reliable delivery promises to your customers, by showing you that portion of your inventory and planned production that is available to fill their orders and on which dates. You can choose between regular (discrete) and cumulative modes of display and can define which components of supply and demand should be included in the calculation.
SYSPRO’s Goods in Transit system provides a mechanism for greater management, control and visibility over stock items that are in the process of being transferred between warehouses. It also forms a core component of the Distribution Requirements Planning system and provides a primary reconcilable book of account.
The Goods in Transit system enables you to record warehouse transfers and produce the necessary paperwork. Visibility is maintained since the entire transaction is tracked from start to completion. Stock is depleted from the source warehouse at the time of confirming each line of the transfer. At the receiving warehouse, a simple review facility enables receipt of transfer items based on selection criteria and processing of exceptions based on the security settings assigned to the receivers. A cost multiplier percentage or value can be applied to receipts to take account of transport costs.
The queries and reports enable monitoring of transfer items, and reconciliation of transfers between source and target warehouses as well as reconciliation of transfer values to the General Ledger. The result is a transparent, audited, documented procedural approach to goods in transit.
An immediate transfer facility is also provided.
Supply chain transfer orders in sales order entry enable you to reserve stock for transfer at a later point in time and provide demand and supply input to SYSPRO’s Distribution Requirements Planning feature.
In SYSPRO, the bill of material (BOM) facilitates the definition of multi-level assemblies, formulae or recipes for manufactured products. In addition to providing for the definition of up to 15 levels of material structures, the BOM provides for the definition of the associated sequence of operations, on up to 10 alternate routes.
The BOM provides the mechanism for calculating accurate lead times, as well as for calculating material and labor requirements for jobs and suggested jobs. Furthermore, it provides for detailed costing at each level and facilitates an accurate expected cost against which to track actual production costs.
Serial tracking is designed to provide full tracking at transactional level for those items that have serial numbers assigned to them and that may carry a warranty. The serial numbers can either be unique per individual item or the same for a batch of items.
The Electronic Signatures system enables you to secure transactions by authenticating the operator who is performing them. This enables you to implement access control at transaction level rather than only at program level. In addition, you can configure the system to maintain a detailed transaction log for auditing purposes, as well as activate triggers for integration to third-party systems or notification via email; the transaction log can be retained indefinitely.
The reason for holding inventory is to provide service to customers whilst dealing with uncertainties in demand and supply. Inventory optimization allows the drivers of inventory to become visible and measurable, providing an understanding of what can be changed and how easily. It quantifies the relationship between the different drivers so that the effect of change can be modeled and the best strategies for optimization identified.
On the demand side, the forecast is a major driver of inventory, coupled to the service level that is targeted for the item. The higher the service level and the less accurate the forecast, the more inventory is required to meet the required service level.
On the supply side, inventory is driven by two major influences – the frequency of the replenishment order and the length and reliability of the lead time. Longer and more variable lead times mean more uncertainty and hence more inventory to balance the risk.
Inventory optimization uses the drivers of inventory to calculate time-phased safety stock at the SKU level, which can then be used to project inventory and cash flow into the future. IO can reduce investment and subsequently ROI, while improving service levels which often leads to improved turnover.
SYSPRO offers both manual and automated pricing. Automated pricing can be based on customer and/or stock code matrices and contract pricing at customer and/or buying group level by product or product group. Discounted, foreign and quantity break pricing methods are catered for as well as minimum profit margin checking. The import, export and global price update facilities enable seamless implementation of extensive price changes. Trade Promotions pricing facilities enable a company to create rules that govern pricing, promotions, special offers and rebates.
SYSPRO’s traceability enables you to maximize quality control through the tracking and replacement of any defective materials and manage product recalls efficiently and effectively.
Companies in highly regulated industries for safety or health compliance such as electronics, aeronautics, defense, food, pharmaceutical, medical devices and motor vehicles would typically benefit this level of traceability. If facilitates tracking material and movement through the receiving, manufacturing, assembly, inspection, stocking and final dispatch stages.
The WIP Inspection programs enable you to inspect made-in stock items before accepting them into stock. The items are received from the job, into inspection and can then either be returned for rework, scrapped or accepted into stock.
Headquartered in Seattle, Washington, the 24-year-old company sells hundreds of products, many of which are patented original designs, to people throughout the world.
For 10 years, Bodypoint operated its business on QuickBooks. With a large and growing inventory of diversified products and growing geographic expansion, Bodypoint outgrew QuickBooks’ capabilities. Bodypoint knew it had outgrown QuickBooks and hired a consultant to help with the search to find a more robust back office technology solution. Over a six-month period, the company reviewed several ERP solutions available to the mid-market manufacturing and distributions market, and ultimately selected SYSPRO.
The SYSPRO software implementation integrated all Bodypoint departments – including sales, accounting, manufacturing, purchasing, inventory and shipping – under one IT umbrella. With all company departments fully integrated, company management had the ability to make rapid, effective decisions utilizing real-time data.
Today, using SYSPRO, Bodypoint has implemented new efficiencies that have made a substantial and financially measurable impact to its operations.
Headquartered in Seattle, Washington, the 24-year-old company sells hundreds of products, many of which are patented original designs, to people throughout the world.
Operating for many years as a multiproduct company via a combination of home-grown technology patched to smaller software packages, TiLite knew that changing its business model to focus on one product would simultaneously require updating to robust ERP technology. The company went from producing five highly customized chairs per day to 70 or more, and expanded into 40 countries.
Today, TiLite utilizes a custom web configuration called EZ-Ti to give customers an easy way to input the specifications and measurements that will make their chairs uniquely their own. EZ-Ti is linked to SYSPRO through Business Objects. These Business Objects automate the order directly into the Bill of Materials (BOM), attach stock codes, build the sales order, and mesh seamlessly into Materials Planning, Factory Documentation, Advanced Quality and other MRP modules.
Installing SYSPRO’s full ERP suite allowed the company to rejig valuable resources to focus on unmet market needs. In 1998, one year after deploying SYSPRO, TiLite produced the first of its flagship “CrossSport” chairs. Today, the company has increased its production 12-fold and substantially expanded its wheelchair product footprint.
“We can’t even imagine having made another ERP choice – SYSPRO has really surpassed our expectations and helped us completely reshape our business.” Evan Derrick – TiLite ERP