an image of how ERP Software For Medical Device Manufacturing results in quality and conformity.

ERP Software For Medical Device Manufacturing

When it comes to medical device manufacturing, the FDA has maintained rigorous standards for manufacturers to satisfy. Traceability,

When it comes to medical device manufacturing, the FDA has maintained rigorous standards for manufacturers to satisfy. Traceability, quality management, and reporting are among the many areas in that manufacturers need superior performance to meet those standards. The FDA’s push for digital means of achieving and providing a record of how standards are met has many businesses looking to ERP software for medical device manufacturing.

Fortunately, ERP systems have been delivering on these demands and more for decades and are suited to meet the changes in regulatory environments. Such powerful systems help to increase the reliability of processes and reduce instances of failures, recalls, and corrective actions. Not only this, but the benefits of ERP make maintaining compliance and records easier and more cost-effective.

The Benefits Of ERP Software For Medical Device Manufacturing

When it comes to the requirements placed on manufacturers by the FDA, it’s easy to see why ERP is increasingly being leveraged to reduce the difficulty in meeting those obligations.

Data is available at every turn in the manufacturing process and ERP systems can help medical device manufacturers leverage that data in the validation process. This data enables management regulatory obligations, optimization of manufacturing processes, and the resulting increase in customer satisfaction. ERP systems capture this vital information to lessen the risks associated with compliance standards and turn efficiency concepts into real-world results with ease.

How Medical Device Manufacturers Use ERP

Compliance is the top motivator for adopting ERP software for medical device manufacturers. FDA regulations, as well as those for international regulatory bodies, are constantly evolving alongside new technologies, products, and research. ERP provides a means of establishing protocols and processes to satisfy the latest regulations at every stage in the manufacturing life cycle.

Accessibility is another important factor driving the adoption of modern ERP systems. Whether in the board room or on the shop floor, teams need the latest data and documentation to make informed decisions, in real-time. Legacy ERP systems lack the connectivity to this data that modern, cloud-based ERP systems provide. Even sales teams on the road require such access when a customer wants to know how a manufacturer’s products conform to the latest regulations, as well as the proof to back it up.

Auditing is a process required both internally and externally for medical device manufacturers. Audits may be scheduled or conducted at random. In any case, a manufacturer wants to know if they can retrieve and report data on every process in the manufacturing life-cycle. ERP software provides all that in a centralized and secure location.

The tracking and traceability ERP software provides will ensure that each stage of the manufacturing process comes with oversight. Easy-to-follow audit trails streamline the process and identify where, when, and how problems emerge. Recalls, while never an easy process, are swift and efficient thanks to ERP software that leverages automated lot and serial tracking to keep customers safe and businesses insulated from risk.

Through automation, manufacturers can remove the manual tasks associated with logging data, such as billing and manufacturing execution. This cuts down on human error that causes most delays and downtime in manufacturing and sales cycles. While not necessarily a matter of regulatory compliance, the efficiency ERP software provides in this regard only strengthens the case for its adoption.

FDA Requirements Of ERP Software For Medical Device Manufacturing

The electronic records and signatures requirements set by the FDA are stringent and any system of manufacturing must comply with the regulations to receive approval. The full body and outline of these regulations as they relate to ERP software for medical device manufacturing can be found in 21 CFR part 11 – ELECTRONIC RECORDS; ELECTRONIC SIGNATURES:

Subpart A-General Provisions 
§ 11.1 – Scope.
§ 11.2 – Implementation.
§ 11.3 – Definitions.

Subpart B–Electronic Records 
§ 11.10 – Controls for closed systems.
§ 11.30 – Controls for open systems.
§ 11.50 – Signature manifestations.
§ 11.70 – Signature/record linking.

Subpart C–Electronic Signatures 
§ 11.100 – General requirements.
§ 11.200 – Electronic signature components and controls.
§ 11.300 – Controls for identification codes/passwords.

and 21 CFR §820 regarding quality:


About Encompass Solutions

Encompass Solutions, Inc. is an ERP consulting firm, NetSuite Solution Provider, and Epicor Gold Partner that offers professional services in business consulting, project management, and software implementation. Whether undertaking full-scale implementation, integration, and renovation of existing systems or addressing emerging challenges in corporate and operational growth, Encompass provides a specialized approach to every client’s needs. As experts in identifying customer requirements and addressing them with the right solutions, we ensure our clients are equipped to match the pace of the Industry.

Sean Balogh

About Sean Balogh

A marketing professional working hard to deliver relevant and engaging content to audiences in education, technology, and manufacturing.