On December 12, 2014, the State Food and Drug Administration issued the management quality specification for medical device business (GSP), which immediately became the red line of leading medical device enterprises’ business life and death. Once the line is touched, the consequences are very serious: minor rectification and fine, major cancellation and withdrawal of GSP certification certificate, resulting in the enterprise unable to operate. In the face of strict regulations, how to prevent and control the headache of GSP touch line risk? To seek the help of special software for medical devices has become the consensus of medical device managers to effectively protect enterprises for many years.
Why must it be proprietary software?
High quality management requirements, the whole process quality traceability is difficult, too many manual work, no integration with ERP Managers often encounter such difficult problems in the process of GSP compliance management. Ordinary medical device management software is difficult to deal with properly, and medical device is a rigorous, conservative industry, no mistakes. Therefore, the choice of special software for medical devices is a wise and easy way to protect enterprises.
On the basic accomplishment of special software for medical devices
So, what kind of accomplishment should medical device software have? Experts come down to six points: data sharing between departments, Bill generation management, etc., record medical device product information to ensure quality traceability, quality control function in business links from purchase to conformity, audit control function of suppliers and distributors, automatic inventory tracking and prevention of overdue function, etc. Is it enough to have these six points? Let’s take a look at the attitude and choice of benchmarking enterprises.
How to make a medical device benchmark?
Acloudear, a medical device digitalization expert and SAP platinum partner, released acloudear, a white paper on digital transformation of medical device industry, after in-depth investigation and analysis of medical device industry. The book not only summarizes the benchmarking enterprise’s practice of using medical device specific software to achieve compliance management such as GSP, but also shows the professional GSP compliance solutions brought by the world-class software SAP cloud to the medical device field for managers.
Take effective quality control measures for “purchase, acceptance, storage, sales, transportation, after-sales service and other links to ensure the quality and safety of products in the operation process.” And other GSP specifications. The solution is better solved by building a quality management platform for industry compliance, establishing a complete product quality traceability system and a series of digital professional management.
In addition, acloudear medical device experts also shared with us: how to meet the CFDA / FDA specification of finished product review and release, meet the CFDA / FDA specification requirements of the whole process barcode management and many other details in line with GSP compliance management.
To sum up, it is not difficult to see that whether it is the construction of quality management platform or product quality traceability system, the CFDA / FDA standard review and release or the whole process barcode management, all these only solve the iceberg of GSP compliance management of medical devices.
Want enterprises to fully solve the problems under the GSP compliance management of medical devices,
You can search and download the complete version of “white paper of digital transformation of medical device industry – acloudear”, and read more detailed comprehensive solutions!
This article "Special software for medical devices, see “72 changes” of GSP compliance management of medical devices" by AcloudEAR. We focus on business applications such as cloud ERP.
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