Don’t Face the Cost of FDA Non-Compliance – Utilize QAD ERP
Posted on: November 25, 2015 | By: Craig Thompson | QAD Manufacturing
The FDA has recently announced new requirements for the distribution and use of medical devices. These unique device identification (UDI) measures will phase in throughout the next few years and will require most medical devices to have unique device identifiers that are capable of being read in human and machine form. These new measures will provide patient safety, device surveillance post market, and medical device innovation.
This means that medical device manufactures will now have to aggregate large amounts of UDI data from multiple sources, verify this data for accuracy and electronically file with the FDA. Not only does this take a large amount of time, this will also effect product configurations, revisions and packaging. Luckily, QAD Inc, has worked with medical device manufacturers to develop a solution to fit UDI needs. With this solution aggregation is automated, serialization and data collection is integrated and records are continuously verified for accuracy. QAD heavily focuses on compliance, quality, and visibility to ensure each and every FDA guideline is adhered to accordingly.
QAD eases the stress of new FDA regulations and ensures that companies do not face the cost of non-compliance. With over 400 life science manufacturing sites, in over 60 countries, QAD has proven to be the leader in effective solutions for medical device manufacturers throughout the world.
For more information on QAD, contact Logan Consulting, your Chicago based QAD partner.
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