7 Key Medical Device challenges SYSPRO can help you resolve:
Comply with Medical Safety Regulations
- 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
Accurately Manage Design Process
- 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
- 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 Materials Planning & Visibility
- 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.
Support complex equipment maintenance, repair and overhaul
- 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.
Streamline Production
- 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.
Reduce time to market
- 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.