Chongqing - With the advent of the digital age, China's National Medical Products Administration has explicitly required pharmaceutical companies to achieve full-process traceability and risk monitoring. 

Chongqing Akso Information Technology Co., Ltd. is a pivotal player in Liangjiang New Area. Their Akso eGMP quality management system, designed for pharmaceutical firms, has earned the trust of over 30 national pharmaceutical giants.

Display wall of Akso. (Photo/Akso)

The International Society for Pharmaceutical Engineering has introduced GAMP (Good Automated Manufacturing Practice), based on the unique nature of pharmaceutical software, to guide pharmaceutical companies in computer system validation.

According to Ran Jun, founder of Akso, any equipment or facility within pharmaceutical companies could impact product quality and patient safety, including software, requiring validation for everything.

Recognizing the opportunity to digitize pharmaceutical operations, Ran, leveraging his 20 years of software industry experience, collaborated with Yu Yongmei from Porton Pharma Solutions Ltd. 

Yu's company sought a digital solution to enhance compliance and mitigate risks. Yu discovered that over 80% of quality management systems were dominated by costly foreign software. Consequently, they decided to challenge this dominance, aiming to develop a domestic pharmaceutical quality management system.

Their three-year dedication led to the creation of the Akso eGMP quality management system with independent intellectual property rights. Tasly Sants, the system's first adopter, had employed Akso's online approval function and witnessed an 86% surge in efficiency.

The success story attracted attention from industry giants like Shandong Xinhua Pharmaceutical Co., Ltd., a global key production and export base for analgesic-antipyretic. This company boasts an annual export volume of nearly 400 million U.S. dollars. 

"We have been looking for a management system for nearly five years, but no one is satisfying us," said a responsible person from Shandong Xinhua Pharmaceutical Co., Ltd. 

After using the Akso eGMP quality management system, the company saw an efficiency surge exceeding 80% within a year of implementation. The system has facilitated over 9,000 approval processes and solved over 17,000 backlogs.

In October, Akso secured an order from MabPlex, surpassing international competitors. MabPlex reported significant cost savings of millions of yuan attributed to Akso's system.

Part of Akso's partners. (Photo/Akso)

These achievements underscore Akso's prowess in delivering tailor-made solutions for the pharmaceutical landscape. Presently, Akso's system has been adopted by over 30 pharmaceutical giants, including Yunnan Baiyao, CSPC, Kelun Pharmacy, and Jiuzhou Pharmaceutical, establishing itself as a  leading brand in China's pharmaceutical quality management system.

This year's important milestone was the addition of Yu Yongmei as chairman and chief quality officer after her retirement from Porton Pharma, making a significant development for Akso. Their inclusion in Chongqing's list of recognized industrial software for 2023 reaffirms their contribution to the industry.

Yu remains optimistic about China's pharmaceutical industry and confident in involving their digital management, emphasizing the need for increased governmental support to expedite growth and development in this sector.