Every medical manufacturer fears one thing: being found noncompliant by the FDA or another regulatory body. Compliance is essential for a medical manufacturer’s reputation and financial future. Because of this, compliance considerations should be integrated into every business process, organizational strategy and software application for medical device, equipment and supplies manufacturers. To ensure compliance, medical manufacturers should utilize an ERP system and make sure their system contains these three key features: role-specific access, traceability and data consistency.
Role Specific Access & Controls
In any QMS (Quality Management System), you have to control who can see and edit pieces of sensitive data. For medical manufacturers, it is necessary to ensure that only the appropriate users can access certain data by setting up permissions and password protection. When implementing an ERP to function as a Quality Management System, you can design your application to neatly align with your business processes by marking certain procedures and fields as required. Once this is set up, you can protect your system by only allowing individuals with specific roles to have the ability to edit these procedures. This means that your standards are locked in and protected from accidental errors. For those who want to save time and money by setting up their business processes correctly in their ERP the first time, contact a trusted ERP consultant like Datix. Our ERP professionals will help you every step of the way for conceptualizing, implementing, and supporting your ERP business processes.
Traceability is necessary for medical manufacturers to meet compliance requirements and track their test cases. The best ERP systems have built in traceability features to track changes from the design to the production and shipping phases. When designing and testing product samples, you can use a traceability matrix to find of the most successful variations with your ERP. To make sure that your production line is running smoothly, you can utilize history, revision and recall tracking. These features are crucial for audit tracking and understanding the strengths and weaknesses within your operations.
When preparing for an audit or inspection to demonstrate compliance, your data needs to be consistent in all of your software. Medical device, equipment and supply manufacturers often utilize multiple disconnected software systems, which can lead to duplicate data entry, time-consuming data review, and inconsistencies due to human error. For those who want to increase accuracy and streamline data entry, consider an ERP integration with your other software. An ERP integration creates transparency and a single source of truth for even the most complex organizations. With a prebuilt application like Unity: Integration by Datix, you can rapidly deploy an ERP integration in as little as three weeks for the most affordable price.
With these key features in your ERP system, any medical manufacturer will have a strong foundation for developing compliant business processes. At Datix, our experts understand the importance of compliance for medical device, equipment and supply manufacturers and dedicate themselves to analyzing each of our clients so that we can develop the best software solutions for you.
Learn more about Datix’s Medical Manufacturing Solutions
For medical manufacturers, Datix is the ERP consultant of choice. We recognize that each manufacturer is unique and requires a tailored solution to meet their business goals. Our team will partner with you every step of the way to bring your organization to the next level.