Medical device, equipment, and supplies manufacturers have a difficult challenge when it comes to supply chain management. Multi-level supply chains require constant oversight, validation, and tracking to maintain compliance for medical manufacturers. Rather than feeling overwhelmed by the complexity of supply chains, the right Enterprise Resource Planning (ERP) system can make supply chain management easier. In this blog, we will cover a few of the ways an ERP can foster strong supply chain management.
Effective risk management and supplier approval are essential to fostering a reliable supply chain. The FDA and ISO 14971 require that medical manufacturers keep customers safe, which means ensuring that your products are safe. Whether harm is caused from an inherent design flaw or from an issue caused by faulty items from a supplier, you are responsible.
An ERP allows you to manage risk directly from your system. You can create a risk management framework to conduct risk analysis and risk evaluation right from your interface. With tools like a risk acceptability matrix or benefit-risk analysis directly available from the ERP, you can balance the probability of harm and the risk severity.
Approved Supplier List
When it comes to suppliers, it is important to assess them before they can be added to your Approved Supplier List (ASL). This assessment should be proportionate to the level of risk associated with the medical device being created (which was calculated during risk evaluation) and should consider how critical the component/service is to your product. You can list a supplier’s accreditations, assessment history and status as an approved supplier right from your ERP.
There is a lot to take on when it comes to risk and supplier management, but it doesn’t need to be overwhelming. A trusted ERP consultant can ensure that you have a setup tailored to your specific needs. Talk to Datix to experience our business-first approach firsthand.
Every aspect of supply chain management requires meticulous tracking for medical manufacturers. This traceability allows medical manufacturers to be compliant with regulations and industry standards like those listed in 21 CFR Part 820, 21 CFR Part 11, and ISO 13485. You track your ASL, risk and supplier evaluations, purchase orders, transactions, validation results, quality inspection data, and so much more. This tracking needs to happen on the macro and micro level. Fortunately, an ERP can allow you to track data for your supplier management as a whole and on the level of an individual supplier facility or even an individual purchase order. This tracking is constant, even after a supplier is approved so that you can spot irregularities and resolve issues as soon as they arise to prevent recalls.
An ERP offers the tools to make monitoring your supply chain easier. You can set up automatic alerts to notify staff when an order needs to be vetted or reviewed. By setting required fields in your inspection and evaluation checklists and automatically recording who completes what task, you can add in the accountability that organizations like the FDA are looking for from your quality system. E-signature functionality can also be set up, following the expectations outlined in 21 CFR Part 11, so that signature requests can be sent out, received, and filed in a matter of minutes.
An ERP consultant can support setting up the tracking functionalities that make supply chain management simple. At Datix, we support our clients from start to finish on their ERP journey using our 25 years of experience. Learn more about a Datix ERP solution for medical manufacturers.
Reporting and Documentation
Like with tracking, every aspect of the supply chain management process must be documented so it can be reported internally and to external parties like the FDA. The right ERP allows you to easily document to demonstrate compliance. Everything is already in your system, so instead of spending hours preparing for inspections and audits, your team can simply pull up your ERP logs and reports within moments to present to the FDA or other regulatory bodies.
Validation and Revalidation
Fundamentally, validation and revalidation are all about continuously checking and ensuring that requirements are being upheld every step of the way while creating and distributing medical devices. Validation is necessary for each component of a product, but critical, high-risk items/services require more extensive validation. Because a supplier’s validation status can change, it is also necessary to track a supplier’s status to ensure it is valid both at the time of the order and at time of receipt.
The right ERP supports revalidation by notifying staff when revalidation is necessary. Generally, your team will come up with a standard revalidation schedule for points along your supply chain based on what they produce. Suppliers and sites that create high risk, critical items/services should be revalidated more regularly than others. In addition, the right ERP will allow you to track unexpected issues with suppliers and trigger responses like expanding your inspection sample size for that supplier in the future.
Quality inspection is critical to supplier management, but the right ERP can make it easier. Because medical manufacturers must validate each supplier site and each distribution point, your team needs to be efficient while completing all the necessary steps of inspection. During inspections, the Quality team should have specific checklists of requirements to check at each facility, which can be kept in your ERP. These will include reviewing how items are stored, handled, and managed. By looking for process gaps that could lead to problems down the line, you can prevent issues before they become major challenges.
An ERP can help organize these complex processes by 1) clearly defining the supply chain per product and 2) establishing triggers for review. If you need a one-stop shop who can support you with your entire ERP ecosystem, look to Datix. As ERP, CRM, integration, hosting, and disaster recovery experts, we can help you with whatever your unique ERP ecosystem requires.
This was only a glimpse of the benefits an ERP can bring on supply chain management for medical manufacturers. A tailored ERP can support medical manufacturers with:
- Risk evaluation using a risk acceptability matrix or benefit-risk analysis
- Complete tracking, and documentation for risk management, validation, revalidation, quality inspection, transaction history and purchase order history
- Containing your Approved Supplier List (ASL) and offering easy access to a supplier’s current validation status
- Automated triggers for scheduling, vetting items, notifying about issues and initiating revalidation
- Streamlining audits or inspections by the FDA
- Supporting e-signatures while meeting compliance requirements
- Pinpointing the exact origin of issues and what products were impacted
- Traceability for transactions by order, lot or serial number and clearly defining the supply chain per product
- Put inspection checklists or other procedures into ERP with required fields, so business processes are completed correctly every time
- Establishing accountability with staff and suppliers
- Maximizing and working in tandem with a LIMS (potentially with an ERP-LIMS integration)
Read more on how to Effectively Manage your Multi-Level Supply Chain in our free e-book
Datix is the ERP consultant of choice for medical manufacturers. Our consultants understand the medical device, equipment and supply industries and dedicate themselves to analyzing each of our clients so that we can develop the best software solutions to maximize their investments to the fullest.