Examples of lifesaving medical devices have been ubiquitous in the news stories of 2020 and 2021. Ventilators, respirators, and the once-scarce personal protective equipment (PPE) we heard about so often at the beginning of the COVID-19 pandemic were essential to the treatment of those afflicted with the deadly disease. As the virus continues to plague us, so too will demand for the crucial medical devices we need in order to combat it.
Faced with the responsibility of inventing and producing the medical devices we depend on, developers must also ensure that these devices do no harm. Because medical device manufacturers operate in one of the world’s most highly regulated industries, they can benefit from using an enterprise resource planning (ERP) system. Pathway Medtech’s sophisticated software solution can make production, purchasing, documentation, and traceability much easier to manage. ERP can also reduce costs, streamline processes, improve efficiencies, and boost transparency without compromising quality, safety, or efficacy.
How ERP Can Benefit the Medical Device Industry
Compliance, traceability, quality control, and time-to-market are all vital to the success of any given product. Because medical devices literally have the power to save lives, none of these factors can be overlooked. An advanced ERP application enables manufacturers to remain flexible and agile under pressure and focus on innovation.
Approval from the U.S. Food & Drug Administration (FDA) is the ultimate goal of medical device manufacturers seeking to bring a new product to market. Gaining that approval in a timely fashion optimizes public health and brings value to the company itself. The FDA, in turn, has a fiduciary responsibility to the American public to approve products that are reasonably safe and effective for consumer use.
To meet this challenge, ERP software must:
Meet FDA software validation requirements
It’s your responsibility to demonstrate and document that your software can accurately and consistently produce results that meet FDA guidelines for compliance and quality management. Medical device ERP solutions can simplify compliance by ensuring that both software and operations meet all FDA requirements.
Provide a complete audit trail of manufacturing processes
The FDA requires that medical device manufacturers keep detailed “audit trails,” or histories, for every step of their procedures. A compliant audit trail must, for instance, identify any design change, who made the change, and the date of the change.
Ensure compliance with ISO quality standards
The International Organization for Standardization (ISO) is an independent, non-governmental entity that develops voluntary international standards. In the United States, ISO 13485 and ISO 14971 guide medical device development and manufacturing processes. Your ERP should ensure that all necessary steps in the product life cycle align with ISO standards and other industry best practices—from design and development to production, installation, and service.
Include FDA-compliant document control
Document control functionality is an essential element of effective ERP. Title 21 of the Code of Federal Regulations (21 CFR) governs food and drugs for the FDA and other federal agencies. The 21 CFR rules dictate the usage and management of electronic records and signatures in relation to regulatory compliance protocols for medical device development. For instance, the FDA requires digital signatures that are compliant with 21 CFR Part 11, so ideally, your ERP should offer this feature.
Integrate CAPA functionality
A corrective and preventive actions (CAPA) subsystem collects and analyzes information to help identify product or quality problems, helping users take preventive or corrective action as needed. Also, if a third-party audit exposes problems, CAPA tracks those results along with the steps taken to resolve the issues.
Deliver lot and serial tracking and traceability
Effective ERP processes should strengthen material management and product traceability in each stage of the supply chain, offering complete control over parts as they move through the production process. Ideally, this solution should track serialized parts and their lot attributes throughout the entire part life cycle to strengthen quality control.
Help manage regulatory compliance requirements
ERP can help IT and accounting managers mitigate weaknesses and strengthen compliance with the Sarbanes Oxley Act (SOX) of 2002. This legislation was designed to improve internal controls over financial reporting. ERP can be used to develop internal controls for the most common material weaknesses reported under SOX, increasing transparency and helping to prevent accounting fraud.
Maintain supplier/vendor data
Quality control largely depends on your suppliers. This is why rigorous supplier evaluation is critical to the FDA (see 21 CFR 820). (Note: A supplier is any entity not covered by your internal quality audit.)
When choosing supply partners, make sure they can meet specified quality requirements. They should also have:
- experience in your industry (or with a similar product);
- capacity and bandwidth to manage your work confidently; and
- a clean record (i.e., no history of product failures or recalls).
To support compliance, the ERP should document your list of approved suppliers. It should also keep track of your vetting and approval process, including selection criteria, references, audits, and performance evaluations.
ERP Gives You a Competitive Advantage
When choosing a medical device manufacturer, it’s best to partner with a company that employs a robust ERP system. This approach can help to:
- Accelerate the production chain
- Reduce company exposure and risk
- Safeguard materials processing
- Consistently meet high standards for quality
Want to know more about the benefits of enterprise resource planning? Contact Pathway Medtech today to schedule a consultation!