Suzhou Fushilai Pharmaceutical Re-Purchases Hippocrates GMP Document Management System (DMS)

From TMS to DMS: Professional Service Wins Deep Client Trust

Summary: Fushilai Pharmaceutical has renewed its partnership with Hippocrates by re-purchasing the GMP DMS system. Following three years of proven TMS results and an in-depth comparison with competitors, Fushilai chose Hippocrates again for its complete document management, ERS electronic records and outstanding service, advancing quality compliance digitalization.

Recently, Suzhou Fushilai Pharmaceutical Co., Ltd. (Stock Code: 301258, hereinafter "Fushilai") officially signed a GMP Document Management System (DMS) cooperation agreement with Hippocrates. This marks another deep cooperation between the two parties following Fushilai's successful deployment of Hippocrates' GMP Training Management System (TMS) in 2022. From training management to document management, Fushilai has once again expanded its digital quality compliance landscape, writing a new chapter in their long-term strategic partnership.

Trust Built on Results: Three Years of TMS Operation, Proven Outcomes

Fushilai is a ChiNext-listed enterprise specializing in the R&D, production and sales of pharmaceutical intermediates, APIs and nutraceutical raw materials, with core products including the alpha-lipoic acid series, carnosine series and phosphatidylcholine series. As one of the world's important suppliers of alpha-lipoic acid series products, its products are exported mainly to overseas markets including Europe, America and Southeast Asia, and the company has passed the GMP certification for pharmaceutical APIs and on-site FDA inspections.

In October 2022, facing increasingly stringent domestic and international regulatory requirements, Fushilai chose Hippocrates among numerous suppliers and first deployed the pharmaceutical GMP Training Management System (TMS, AcadTrust®). After going live, Fushilai quickly established a standardized and efficient training management system:

• More than 500 on-board employees enrolled in online training, achieving closed-loop management of job qualifications;

• Over 200 sets of self-developed training courseware and exam papers produced monthly, more than 20 internal trainers cultivated, and each employee completing over 80 online learning sessions per quarter on average;

• Overall time for organizing training reduced by about 70%, training effectiveness statistics efficiency improved by over 70%, and on-the-job training effectiveness improved by about 40%.
• More importantly, Hippocrates' TMS helped Fushilai successfully pass the FDA's on-site inspection of its training system recently, earning recognition from international regulators through solid, compliant and traceable training records — the system's value has stood the test of an "international examination."

In-Depth Comparison of Competitors: Comprehensive Strength Wins

As an established pharmaceutical company that has undergone FDA on-site inspections, Fushilai has always been prudent in selecting quality digital systems. Before making the re-purchase decision, Fushilai's project team conducted focused evaluations of other competitors in the industry, making in-depth comparisons on core capabilities such as DMS's complete document management and ERS electronic records, and assessing multiple dimensions including functional completeness, regulatory compliance, system stability, implementation & validation capability, and service support.

In the comparison, Hippocrates' advantages became increasingly evident: built on the OwlTrust digital platform, its DMS delivers full-lifecycle management of documents from drafting, approval, distribution, publishing, training, effective dating, version upgrade to review and retirement; its ERS electronic records and other functions strictly follow the requirements of FDA 21 CFR Part 11 for authentic, complete and traceable electronic records, seamlessly aligning with international regulatory requirements; moreover, DMS and the TMS already running at Fushilai are built on the same platform and integrate naturally, avoiding compliance risks and duplicate construction costs caused by fragmented systems.

After multi-dimensional, in-depth comparison and comprehensive evaluation, Fushilai ultimately cast its vote of trust to Hippocrates.

Service Wins Re-Purchase: Professional, Responsive, Supportive

When talking about the reason for this re-purchase, the relevant project leader at Fushilai said: "After more than three years of cooperation with Hippocrates, the deepest impression is 'professionalism' and 'peace of mind.' Whether it is the early-stage Computer System Validation (CSV), implementation and delivery, or problem response and audit support during daily use, the Hippocrates team can always provide fast and accurate solutions. Good service is the most direct reason for our re-purchase."

In the field of pharmaceutical quality management, system go-live is only the starting point; continuous and reliable service is what truly delivers digitalization. Hippocrates has always adhered to its positioning as a "quality compliance expert," providing clients with full-lifecycle services covering implementation, validation, operation & maintenance, and audit support. It is precisely this service quality throughout the journey that has led leading pharmaceutical companies such as Hengrui Medicine, Shanghai Pharma, Livzon Group, Changchun Jinsai and China Resources Pharmaceutical to continue cooperating with Hippocrates.

From TMS to DMS: One Step Further in the Quality Compliance Digital Loop

The Hippocrates GMP Document Management System (DMS) re-purchased this time is one of the core products of the OwlTrust digital platform. Designed around GMP document system requirements for pharmaceutical enterprises, it covers the full lifecycle of documents — drafting, approval, distribution, publishing, training, effective dating, version upgrade, reissuance, printing, review and retirement — with multi-version control and flexible workflow configuration, strictly following domestic and international standards including GMP, ICH Q7a, FDA 21 CFR Part 11, EU-GMP (ANNEX 11) and ISPE GAMP5.

After go-live, Fushilai's SOP and quality document management will fully move away from paper-based circulation, achieving electronic, controlled and traceable management. More importantly, DMS will integrate seamlessly with the existing TMS — document effectiveness automatically links with personnel training, forming a complete quality loop of "document release — training implementation — record traceability," providing a more solid digital foundation for Fushilai to continuously meet domestic and international regulatory requirements such as FDA and NMPA.

About Hippocrates

Hippocrates is a provider of quality compliance digital solutions in the life and health sector. Its self-developed quality compliance suite of QMS, DMS and TMS ranks among the first tier in China, with other products including VDR, e-Sign, PVS and EBR, supporting group-level and global deployment, and providing one-stop services in compliance control, data governance and CSV validation. Since its establishment, Hippocrates has provided digital solutions and professional services to more than 300 enterprises and institutions, helping more safe, effective and reliable products reach the market faster.