ERP systems, once a one-size-fits-all proposition, have splintered in recent years, with specialized versions geared specifically to serve very narrow niches with very specific requirements. Such it is with ERP systems built from the ground up for medical device manufacturers. If that’s the corner of the world in which you compete, it’s a sure bet that the first thing on youer mind is, how can an ERP system automate compliance with the complex government regulations spawned in recent years as a safety imperative? Medical device manufacturers, in fact, are turning more and more frequently to innovative software solutions for exactly those compliance concerns.
ERP Essentials for Medical Device Makers (Part 1)
Today’s leading ERP solutions go beyond the historical ERP strengths of finance and accounting to help medical device manufacturers achieve complete process visibility — enabling them to comply with the documentation, safety controls, quality management, and traceability requirements of regulations such as FDA regulations 21 CFR 820 Quality System Regulation (QSR) and 21 CFR Part 11, along with ISO regulations ISO 9001 and ISO 13485:2003. Not only do today’s solutions help manufacturers meet these mandates, they enable the highest levels of quality, productivity and profitability.
ERP systems are ideally suited to the pursuit of complete compliance because they are the ideal vehicles for capturing data, enforcing “best practices,” validate manufacturing processes, ensuring product specifications are adhered to, and providing rapid access to that information in precisely the format and detail required by regulating bodies. Let’s face it — a mistake that leads to a Form 483 letter from the FDA can cause enormous harm to a company, in some cases leading to complete shut-down. The fact that advanced ERP systems are available and improving all the time is good news for medical device manufacturers.
Any of the leading ERP solutions geared for medical device manufacturers must provide all five of the following “must have features”:
Accessible, Real-Time Information In order to meet government mandates, medical device manufacturers must have quick and easy access to all data related to all of their products, at all times.
You will need a system that enables you to provides a complete trail of critical data about a medical device manufacturer’s products, including details regarding specific materials used, processes performed, suppliers used, operator training, quality test results, and more. Real-time, accurate, and accessible data must be available to all users at any time through simple Internet access. Every department accesses the same information. Such a system can provide a highly actionable “single version of the truth” – and provides the necessary audit trails to prove it.
Integrated Solution. Medical device manufacturers cannot afford the inconsistency and confusion that can result if different software systems manage different parts of their operations. They simply must have an integrated manufacturing solution where data is linked across all functions, enabling 100 percent accuracy and consistency. For example, a standalone quality management system is no longer an acceptable deployment model; quality data must be an integral part of the ERP system.
Ideally, your ERP systems should integrate Manufacturing Operations Management (MOM) and Quality Management Systems (QMS) for the shop floor, Supply Chain Management (SCM) for procurement, and Enterprise Resource Planning (ERP) for finance and management.
Continued in Part 2