Recently, Zhejiang Beihede Pharmaceutical Co., Ltd. ("Beihede Pharma") has formed a strategic partnership with Shanghai Hippocrates Health Technology Co., Ltd. ("Hippocrates"), officially launching the eGMP Digital Project. This collaboration focuses on the digital upgrading of quality management, with key implementation of two core systems: Document Management System (DMS) and Training Management System (TMS). The project marks a crucial step for Beihede Pharma in its digital transformation journey, laying a solid foundation for the company to build a standardized and intelligent quality management system and further empowering its high-quality development.
01 Project Background
Founded in 2010, Beihede Pharma is a wholly-owned subsidiary of PHT International. Specializing in the R&D and production of high-quality pharmaceutical intermediates and Active Pharmaceutical Ingredients (APIs), Beihede Pharma mainly targets overseas markets with its core products and undergoes regular audits by overseas clients and authoritative institutions such as the FDA. Adhering to quality as its core principle, Beihede Pharma is committed to optimizing its quality management system through digital means. The eGMP Digital Project will achieve the goals of standardization, efficiency, and traceability in document management and training management, injecting new impetus into the company's high-quality development.
02 Project Kick-off Meeting
To advance the implementation of the eGMP Digital Project in an all-round manner, Beihede Pharma and Singdi jointly held the "eGMP Digital Project Kick-off Ceremony". Heads of relevant departments of Beihede Pharma (including Quality, Production, R&D, and IT) as well as project team members, together with Singdi's project team, gathered to discuss the development path and future value of digital management.
During the kick-off meeting, the two parties conducted in-depth discussions on topics such as the digital upgrading of DMS and TMS, compliance assurance, and how to meet overseas regulatory requirements. They also reached consensus on the project implementation plan, laying a solid foundation for the smooth progress of the project.
03 Leadership Speeches
Mr. Jiang Wei, Deputy Plant Director & Quality Director of Beihede Pharma
Mr. Jiang Wei stated that Beihede Pharma underwent multiple rounds of inspection and comparison during the vendor selection process, and was ultimately attracted by the integrated business design concept and international compliance capabilities of Hippocrates's OwlTrust® (OwlTrust) GMP Digital Platform. He expressed high expectations for the project, hoping that Hippocrates, leveraging its rich quality management experience in serving international enterprises, will help Beihede Pharma build a more robust quality compliance system and comprehensively enhance its core competitiveness in the global pharmaceutical market.
Mr. Jiang also put forward clear requirements for the project team, emphasizing that all members must strictly follow the project plan to advance various tasks in an orderly manner. Under the guidance of Singdi's professional team, each milestone should be achieved on time with high quality to ensure the successful implementation of the eGMP Digital Project.
Dr. Tan Ping, Chief Operating Officer (COO) of Hippocrates
At the project kick-off meeting, Dr. Tan reviewed Hippocrates's nearly 20-year development journey. He pointed out that as a professional digital company in the life sciences and healthcare sector, cooperating with Beihede Pharma will help the latter meet international standards and regulatory requirements such as those set by the FDA, EMA, and WHO. Against the backdrop of increasingly stringent global regulation in the life sciences and healthcare industry, international enterprises are in urgent need of digital platforms that comply with international practices. Hippocrates's Aotai Platform is tailor-made for this purpose—it deeply integrates regulatory modules such as FDA 21 CFR Part 11 and EU GMP Annex 11, and embeds industry best practices including ICH and ISPE GAMP5. Covering core scenarios such as document management, quality management, and contract manufacturing collaboration, the platform enables end-to-end compliant traceability and intelligent data analysis.
Dr. Tan finally pledged that Hippocrates's team will ensure the high-quality implementation and stable operation of the project through agile delivery, customized training, and long-term technical support.
04 About the OwlTrust® (OwlTrust) Digital Platform
OwlTrust is an integrated digital platform for quality and compliance developed by OwlTrust with dedicated efforts. Jointly built by experts in the GMP industry and digital field, the platform strictly adheres to standards and regulations such as GMP, cGMP, ICH, FDA 21 CFR Part 11, EU-GMP (Annex 11), and ISPE GAMP5. With "Quality & Compliance Expert" as its management philosophy and market positioning, OwlTrust® helps pharmaceutical enterprises improve their quality and compliance levels, meet industry regulations, accelerate the launch of more safe, effective, and high-quality products, and realize greater health value.
05 Introduction to Both Parties
About Beihede Pharma
Founded in 1993, PHT International is headquartered in Charlotte, North Carolina, USA. As a professional enterprise focusing on the supply of high-quality chemicals, its products cover multiple fields including pigments, dyes, pesticides, and pharmaceuticals. Relying on stable product quality and professional service capabilities, PHT International holds a solid position in the global chemical industry.
As a wholly-owned subsidiary of PHT International, Zhejiang Beihede Pharmaceutical Co., Ltd. was established in 2010. It has always strictly followed FDA standards, focusing on the R&D and production of high-quality pharmaceutical intermediates and APIs, and is committed to providing domestic and foreign clients with end-to-end services for small-molecule drugs from R&D to production.
About Hippocrates
"Hippocrates" is a transliteration of "Hippocrates"—the father of ancient Greek medicine. Hippocrates is a leading provider of digital solutions in China's life sciences and healthcare sector. It is dedicated to helping enterprises in the life sciences and healthcare field (including pharmaceuticals, medical devices, and cosmetics) achieve digital transformation through innovative technologies and products.
Hippocrates's business scope covers GMP quality management, digital factory construction, GVP Pharmacovigilance, and GCP Clinical Research. It has served over 200 clients in China, established overseas branches, and formed cooperative relationships with a number of multinational enterprises.
