Medical Device Manufacturing Software
SYSPRO ERP business software solution for Medical Devices Manufacturing
As one of the most highly regulated industries in the business world, medical device manufacturers experience countless challenges on a daily basis. Product traceability, strict quality requirements and compliance with the FDA, government, and other regulatory requirements, are just some of the critical factors that can determine an organization’s success. Your business is dependent upon following closely controlled processes to produce superior products that meet stringent quality standards, while having the ability to provide documentation to validate all procedures. That’s why Class 1 and 2 medical device manufacturers turn to SYSPRO for functionality that helps sustain their competitive advantage.
The SYSPRO solution is designed to help you address these issues and manage the five key components of a medical manufacturing business: Design, Manufacture, Distribution, Maintenance and Service. SYSPRO provides powerful manufacturing capabilities, with the tools needed to improve customer satisfaction with quick responses to changing consumer needs, gain full visibility into the supply chain that helps businesses exceed goals.
7 Key Medical Device challenges SYSPRO can help you resolve
$612.7bn
The global medical devices market size is expected to reach USD 612.7 Billion by 2025, showing a CAGR of 5.4% from 2018-2025.
Close the gap between ERP and your quality system with SYSPRO providing security configured at system, company, group and role of operator level; and electronic signatures for record binding and operator authentication.
Provide full bi-directional traceability from source to consumption
Manage all steps in the non-conformance process and generate corrective actions and other workflows that link right to the original non-conformance
Produce detailed audit trails of all transactions
Manage the investigation and resolution of customer complaints in compliance with FDA guidelines
Authenticate operators for specific transactions
Support FDA 21 CFR Part 11 and Good Manufacturing Practices (GMP) requirements
Eliminate redundant data entry with real-time integration to CAD.
Control design and release process with Engineering Change Control.
Eliminate paper trail with user defined approval process.
Electronically notify of required actions, accompanied by instructions, comments, documents and drawings.
Define all the production resources, including raw materials, machines, labor and quality variables.
Provides a ‘replace component where-used’ facility that enables the quick replacement of one item with a valid substitute item.
Track variances and defects.
Manage subcontract operations to suppliers.
Allow contract manufacturers to fulfill their requirement without access to the main system.
Procurement and Supplier Relationships have an increasingly important role to play in ensuring Manufacturers and Distributors achieve specific strategic goals, with strategic procurement sourcing policies often enabling a competitive advantage.
It’s not just about buying raw materials, it’s also about partnering with suppliers to secure longer term preferential agreements for the best quality input materials at the lowest cost.
Of equal importance in the Medical Devices industry are the controls, governance and oversight required to ensure that procurement activities within the organization are ethical and support compliance with industry regulations.
SYSPRO facilitates and optimizes the management of sourcing strategies for material, and for the recommended selection of suppliers during your purchasing cycle.
Optimize inventory levels with accurate forecasting to minimize forecast errors and improve order fulfillment performance.
Place stock codes, lots and bins on hold to prevent usage of discrepant material.
Define restrictions by user to either deny access or limit access to a warehouse.
Monitor transfers between multiple warehouses to provide complete visibility.
Manage purchasing process with the requisition approval workflow.
Expedite the purchasing process by creating and submitting RFQ to prospective suppliers.
Control the return and exchange of items bought from suppliers.
As a critical after-sales service in the industry, MRO requires detailed record-keeping of customer equipment configurations, as well as previously performed maintenance work, in order to meet service-level agreement requirements.
SYSPRO’s Product Configurator simplifies the raising of orders for variable configurations, while the Bill of Materials, Engineering Change Control and Work-in-Progress modules provide the recording and tracking of as-built and as maintained configuration history and service notes, including details of any subcontracted work.
Additionally, SYSPRO’s Serial Tracking and Lot Traceability functionality provide reliable part warranty and replacement details and history. Thus, the extraction of maintenance history and current configuration details is facilitated for customer regulatory reporting, as well as to enable customer-targeted planning of materials and activities for service and repair jobs.
Minimize costs with advanced capacity planning and scheduling tools.
Resolve bottlenecks faster with real-time Work in Progress monitoring and exception alerts.
Get a clearer view of raw materials, machines, labor and quality variables.
Reserve lots and/or serials for parent parts and components for correct issuance of materials for finished goods.
See trends and patterns for rework so you can eliminate errors due to quality issues.
Know who worked on what, when, with full audit trail reporting.
With rules-based Product Configurator streamline order-taking and automatically generate factory and purchase orders with all the relevant detail, such as materials and operations required to make or assemble the correct customer-specific configuration of the product.
For complete engineer- and design-to-order requirements, speed up the processing of inquiries through estimating and quotations functionality that provides an accurate view of both standard and non-standard material and labor costs, ensuring accurate profitability projection and quoting.
Get a clearer view of raw materials, machines, labor and quality variables.
ERP for Medical Devices – Boost Your Operations with SYSPRO ERP Software
- Control repair and replacement of warranty controlled items, monitor warranty cost, view information on incoming products, repair orders and manage shipping of replacements items.
- Manage regulatory requirements including 21CFR Part 11, GMP and ISO with fully integrated processes based on component receiving, production, packaging and shipping steps. Provides electronic signatures with transaction audit traceability.
- Improve your customer responsiveness in all aspects from design, engineering and configuration.
- Digitally transform your business so that you can integrate business partners across your supply chain or to other systems, on premise or in the cloud.
- Leverage the power of Artificial Intelligence and Machine Learning to get rich insights, unidentified trends and anomalies in your business brought to the forefront.
- Build customer satisfaction with more accurate quoting and estimating.
Business Critical Solutions for the Medical Devices Industry
Industry-built to support your quality and safety systems, SYSPRO ERP offers a full traceability system which enables manufacturers to:
Track materials from receipt right through to delivery of the product to the customer, as well as at any level in between.
Rapidly identify, quarantine and retrieve potentially defective goods from customers.
Accelerate the time to completion of your product recalls.
Improve governance and drive compliance.
Continually test and improve your traceability system.
Remain compliant and meet regulatory reporting requirements.
Mitigate the risks associated with recall.
Engineering Change Control (ECC) is crucial to quality control and is a requirement for ISO and QS certification. The solution helps you improve the management of engineering changes to your products and/or associated data by enforcing controls in production. ECC provides detailed audit reports of all transactions, including all historical changes and the operator performing the change to meet compliance requirements.
SYSPRO Reporting Services (SRS) enables you to produce professional-looking reports quickly and with minimal effort – providing a single, cost-effective solution that simplifies operational effectiveness.
SRS comes with an impressive array of predefined reports that work ‘out-of-the-box’, enabling businesses to derive immediate benefit. However, its true power lies in the total flexibility it gives businesses to design custom reports to virtually any level of complexity, complete with tailored reporting options, preferences and layout features.
SYSPRO’s Bill of Materials supports businesses through each stage of the development process and allows users to manage components, routing steps and products specs using secure and flexible methods.
Preferred Supplier is a feature within SYSPRO’s ERP that facilitates and optimizes the management of sourcing strategies for material, and for the recommended selection of suppliers during your purchasing cycle. By establishing and managing strategic sourcing policies in SYSPRO’s Preferred Supplier feature you can decrease your purchasing risk, improve purchasing governance and ultimately achieve cost reductions.
A powerful addition to help optimize factory output and reduce job costs is which balances loads between specialist and generalist equipment and on to specialist artisans and increases overall factory efficiencies. Implementing this software will lead to more accurate delivery dates through the ‘capable-to-promise’ functionality. To exploit the full potential of these features, Medical Device manufacturers need end-to-end integration across the entire business cycle, and this can only be achieved through an integrated ERP system from a company that understands and specializes in manufacturing.