Medical device manufacturers face similar challenges, whether engaged with Medical Device Production, BioPharma & Nutraceuticals, Contract Development & Manufacturing, or Biotechnology. They all face dynamic product lifecycles from development and clinical trials through to distribution and revenue, and a demanding regulatory environment that requires tracking everything. They also often face complex supply chains and demanding, multi-country compliance and reporting.
For all of these challenges, a cloud-based ERP solution is essential.
What is Cloud ERP?
Cloud ERP is end-to-end business software that helps manage all aspects of a medical device manufacturing business from product development and manufacturing to sales, marketing, customer service, and compliance. It gives medical device manufacturers a complete view of all business operations and serves as the central platform for managing company data and leveraging it for strategic direction, efficiencies, and regulatory requirements.
What to Look for When Choosing an ERP as a Medical Device Manufacturer
Because medical device manufacturing is a highly regulated industry with specific industry needs, it is important to select an ERP that fully supports the needs of the business. While most mainstream ERP solutions can ultimately be configured for the needs of a medical device manufacturer, choosing a solution that is ready for these needs out-of-the-box will significantly cut costs and implementation headaches.
Key considerations when selecting an ERP for medical device manufacturing include FDA validation requirements, regulatory compliance, product traceability, and complete visibility of the manufacturing process.
FDA Validation Readiness
Unlike most other businesses, life sciences firms such as medical device manufacturers must have their systems FDA validated. This consists of demonstrating that the processes in place at a medical device manufacturer actually conform and perform as specified according to FDA guidelines.
Medical device manufacturers will want an ERP solution that comes FDA validation-ready or at least enables process validation in parallel with ERP system implementation.
Proper Signature Compliance
As with system validation, medical device manufacturers must follow FDA guidelines around electronic signatures regarding their backend systems. Specifically, life sciences firms need to follow 21 CFR Part 11, which allows for electronic signatures but comes with specific requirements.
To be compliant, a medical device manufacturer’s system must support digital signatures that include the signer's printed name, the date and time of the signature, a unique user ID, a digitally adopted signature, and the meaning of the signature (labeled "signing reason").
So when selecting ERP software, medical device manufacturers must select a system that fully complies with 21 CFR Part 11 digital signature requirements.
Lot and serial number tracing is crucial in medical device manufacturing for several reasons. It allows manufacturers to quickly and accurately identify and isolate products that may be defective or non-compliant, it minimizes the risk of harm to patients, and it reduces the likelihood of costly recalls.
Further, lot and serial number tracing provides manufacturers with detailed information about the components and materials used in the production of each device, making it easier to identify potential issues and improve quality control.
One of the most important functions of ERP for medical device manufacturing is having trace and trackability. Make sure that the ERP chosen enables it out of the box.
Full Manufacturing Visibility
Complete control and visibility, and an audit trail of manufacturing processes, are essential in medical device manufacturing to ensure compliance with regulations and quality standards.
Full visibility enables identifying potential issues, tracking resources, and monitoring steps in the manufacturing process for standardization. An audit trail helps trace each product to its source and identify issues, critical during product recalls.
When looking at ERP solutions, make sure it connects with other systems, provides real-time visibility, tracks every aspect of production, and offers an audit trail.
A Prepackaged Industry Solution Makes ERP Rollout Easy
As an SAP Gold Partner with more than 500 ERP implementations under our belt, we’ve helped dozens of medical device manufacturers put the right ERP system in place.
Because we understand the needs of medical device manufacturers, we’ve developed a turnkey, prepackaged ERP industry solution built on the SAP Business ByDesign platform that comes ready for the needs of medical device manufacturers out-of-the-box.
There are a number of benefits that come with using a prepackaged industry solution, including:
A ready-to-validate platform. The ERP solution supports the compliance needs of medical device manufacturers by default, significantly cutting validation time and cost.
CFR Compliant. Our prepackaged ERP solution is CFR 21 Part 11 compliant for the digital signature requirements of a medical device manufacturing operation.
Superior track & trace. Automated serialization and track and trace functionality build into the solution ensures that all inputs and final products are tracked throughout the manufacturing and distribution processes.
Comprehensive analytics. Modern business runs on data, especially life sciences businesses. Our prepackaged industry solution for medical device manufacturers both manages all company data and delivers insights for greater efficiency and strategic planning.
Suite-in-a-Box. Everything your business needs comes with the solution, including financials, sales, supply chain, production, project costing and management, human resources, quality control, and time & expense management.
Total lower cost of ownership. Not only is the solution built on a flexible, scalable cloud infrastructure that is pay-as-you-go, it also reduces rollout time and expense by coming pre-configured.
Speed up time to market and improve operations by using a prepacked ERP solution that is built for the needs of medical device manufacturers. Learn more about our prepackaged industry solutions here.
You also can ask specific questions related to ERP and your business by contacting one of our experienced ERP consultants at (801) 642-0123 or by writing us at email@example.com.