Assuretech Co., Ltd. Launches SAP Project and Conducts Computerized System Validation (CSV) in Partnership with Hippocrates
Zhejiang Assuretech Co., Ltd. (“Assuretech”) has achieved another key milestone in its digital‑transformation journey with the official go‑live of its new SAP global intelligent operation platform. As a high‑tech enterprise specialized in POCT in‑vitro diagnostics, Assuretech’s products are sold to more than one hundred countries and regions worldwide. Its business growth requires alignment with multiple compliance frameworks including FDA, WHO and EMA requirements. To fully guarantee compliant operation of digital systems for cross‑border business and reinforce the data‑integrity management system under multi‑national regulatory inspections, Assuretech has partnered with Hippocrates to launch the SAP Computerized System Validation (CSV) project. By advancing global operation development and compliance‑system construction in parallel, the enterprise continuously enhances cross‑border quality control capabilities and competitiveness in international markets.
As a core initiative under Assuretech’s global‑strategy, the newly‑launched SAP system adopts a globally‑deployed architecture to build an integrated ERP management platform covering group‑level finance, cross‑border supply chain, production control, quality management and global sales. It fully satisfies regulatory requirements from FDA, WHO, EMA and other authorities, as well as full‑lifecycle product traceability mandates. Deep‑level integration is realized with MES, LIMS, QMS and global logistics traceability systems. The end‑to‑end digital loop spans raw‑material procurement, cross‑border manufacturing, quality testing and global warehousing & distribution. It enables electronic batch‑record management, real‑time full‑process quality monitoring and cross‑border batch traceability, effectively resolving fragmented quality‑data challenges across multiple manufacturing sites and diverse regulatory regimes. Product‑quality consistency worldwide and supply‑chain response efficiency are substantially improved.
Following the full deployment of SAP, digital compliance management has become a critical driver for operational excellence within Assuretech’s global business. The Hippocrates‑delivered CSV validation project strictly benchmarks authoritative domestic and international standards, including Chinese GMP, EU GMP Annex 11, FDA 21 CFR Part 11 and WHO data‑integrity guidelines. Full‑lifecycle validation activities are performed around core compliance dimensions: system access‑rights management, audit trails, electronic signatures, data backup and recovery, change control, and cross‑border operation & maintenance management. System‑operational risks under multi‑organization, multi‑language and multi‑regulatory environments are systematically identified and remediated. Standardized validation frameworks and global operation‑maintenance management systems are refined to ensure all production, quality and distribution data are authentic, accurate, complete and traceable, in full conformance with international compliance norms.
To date, the project has completed system surveys across global manufacturing sites, GxP criticality assessment, risk evaluation and gap analysis. Compliance remediation and validation activities are progressing steadily. The deep integration of SAP global‑platform implementation and CSV compliance validation further matures Assuretech’s global intelligent operation‑control system, strengthens its compliance competitiveness when facing multi‑national regulatory audits, and consolidates its leading global position within the POCT in‑vitro diagnostic sector. It also serves as an important reference for Chinese medical‑device enterprises pursuing overseas expansion and international compliant operations.
