To achieve compliance with new domestic regulations in China and facilitate international sales, Resources Jiuxin aimed to digitize its good manufacturing practices (GMP) system.
Resources Jiuxin selected a GMP workflow and document management solution powered by IBM Notes and Domino—offering the company an efficient route to compliance with the new regulatory requirements.
Up to 50%reduction in GMP costs predicted thanks to greater automation
Up to 92%faster preparation for compliance inspections frees time for value-added work
Up to 50%cost-savings on paper by adopting digital processes
Business challenge story
Tackling new regulations
For pharmaceutical manufacturers, effective quality control is crucial for consumer safety. Around the world, regulatory bodies establish and enforce good manufacturing practices (GMP) to ensure products are of a consistently high quality.
In China, the Food and Drug Administration (CFDA) is responsible for assessing GMP standards at pharmaceutical manufacturers. In the past, manufacturers recorded GMP data on paper, which they compiled into reports when CFDA inspectors performed on-site inspections. Paper-based processes consumed a significant amount of time and administrative resources for manufacturers and the CFDA alike. To enhance efficiency, the CFDA mandated in 2015 that all pharmaceuticals manufacturers transition to digital GMP records.
Shenzhen Resources Jiuxin Pharmaceutical Co., Ltd. recognized that being an early adopter of the new GMP standard would do more than shrink its exposure to regulatory risks. A spokesperson for the company comments: “International markets represent a valuable opportunity to drive our growth. By embracing digital GMP workflows, we knew we would also reduce the cost and complexity of demonstrating GMP compliance to regulatory bodies such as the US Food and Drug Administration and the World Health Organization—shortening our time to market.”
Making a path to compliance
“We felt the IBM Notes and IBM Domino solution was a better fit for our needs than the open-source platforms we considered,” continues the spokesperson. “Because we work in a highly regulated industry, information security is a top priority. By selecting a global technology enterprise like IBM, we knew it would be straightforward to demonstrate our compliance with critical security and encryption standards—something that would have required substantial additional work if we’d adopted an open-source platform.”
The spokesperson continues: “Another reason we valued the IBM offering was the ability to combine workflow management and content management capabilities in a single platform. As well as delivering a complete audit trail of all changes made to digital GMP records, our IBM Domino solution enables us to archive and retrieve data rapidly—making it even easier to build compliance reports.”
By engaging a China-based IBM Business Partner to implement the solution, Resources Jiuxin gains the assurance that the new GMP workflows will integrate seamlessly with its business processes.
“All of the other vendors we considered were based on international GMP solutions localized for China, but the IBM solution was built from the ground up for use in our market,” explains the spokesperson. “All of these factors contributed to a total cost of ownership that was far lower than the other platforms we evaluated.”
Reducing costs and cutting time to market
Working together with IBM and its IBM Business Partner, Resources Jiuxin is preparing to move its GMP solution into production. When the new platform goes live, all new GMP data will be captured in the platform—replacing the company’s paper-based processes.
“Moving to digital GMP workflows is going to make a big difference to our quality management function,” says the spokesperson. “While we previously needed up to two weeks to prepare our GMP data for inspection by the CFDA, we’ll soon be able to pull together the information via the IBM solution in less than one working day. Because of the vast reduction in manual work, we anticipate we will be able to reduce our operational costs by as much as 50 percent. The IBM Notes and Domino solution will also enable us to reduce our use of paper dramatically, which could cut our spend on those supplies in half.”
Based on the success of its partnership with IBM to date, Resources Jiuxin is planning future use cases for the IBM Notes and Domino platform. After the launch of IBM Domino 10, the company plans to make its GMP application available on mobile devices—enabling employees to enter GMP directly into the system from the manufacturing facility floor. The company is also considering the possibility of deploying the on-premises edition of IBM Verse® to create a dedicated private channel for sharing GMP data within the organization.
“Our parent company manages ten subsidiaries in the pharmaceuticals space, and we may eventually be in a position to use our IBM Notes and Domino platform as a centralized hub for GMP management across the group,” comments the spokesperson. “By gaining economies of scale, we believe there could be scope for reducing group-wide operational costs by as much as 40 percent.”
The spokesperson concludes: “The IBM Notes and Domino solution is helping us build a robust, data-driven platform to reduce the cost and complexity of regulatory compliance and reach international markets faster.”
About Shenzhen Resources Jiuxin Pharmaceutical Co., Ltd.
Founded in 1991 and based in Shenzhen, China, Shenzhen Resources Jiuxin Pharmaceutical Co., Ltd is a pharmaceuticals manufacturer and marketer. A subsidiary of China Resources Sanjiu Medical & Pharmaceutical Co., Ltd., Resources Jiuxin was among the first domestic pharmaceutical manufacturers to obtain a certificate of GMP compliance from the China Food and Drug Administration.
Take the next step
To learn more about IBM Domino, please contact your IBM representative or IBM Business Partner, or visit the following website: ibm.com/marketplace/ibm-domino
To learn more about IBM Notes, please contact your IBM representative or IBM Business Partner, or visit the following website: ibm.com/marketplace/enterprise-email