韩国富士通推出 MasterControl Ax，补齐 Qx、Mx、Ax 质量制造资产三件套

韩国富士通发布 MasterControl Ax 的宣传图，屏幕内为 Ax 设备维护界面，韩文环境运行（图源：biopharmaapac.com）

Korea Fujitsu Completes MasterControl's Quality, Manufacturing and Asset Trio in Korea with Ax Launch

来源：BioPharma APAC

URL：https://www.biopharmaapac.com/news/70/8527/korea-fujitsu-completes-mastercontrols-quality-manufacturing-and-asset-trio-in-korea-with-ax-launch.html

发布日期：2026-10-06

场合：韩国富士通宣布在韩国推出 MasterControl Ax（Asset Excellence，资产卓越）云端资产管理平台，面向制药、生物技术与医疗器械企业

The launch gives Korean pharma, biotech and medical device manufacturers a life sciences-specific, cloud-based system for one of the last largely manual corners of GMP operations: the maintenance and calibration of the assets that every batch and every test result depends on.

此次上线为韩国制药、生物技术与医疗器械企业提供了一套生命科学专用、云端部署的系统，覆盖 GMP 运营中最后一块仍以手工为主的领域：设备维护与校准——每一个批次、每一个检验结果都依赖这些资产。

Korea Fujitsu has announced the South Korean launch of MasterControl Ax (Asset Excellence), a cloud-based asset management platform developed by US quality software company MasterControl for the pharmaceutical, biotechnology and medical device sectors. The move marks a notable step in the country's push toward fully digital, inspection-ready manufacturing, extending structured digital control beyond quality and production systems into the facilities, instruments and laboratory equipment that sit underneath them.

韩国富士通宣布在韩国推出 MasterControl Ax（Asset Excellence，资产卓越），这是美国质量软件公司 MasterControl 面向制药、生物技术与医疗器械行业开发的云端资产管理平台。此举标志着韩国向全面数字化、检查就绪型制造迈出重要一步，将结构化数字控制从质量与生产系统延伸到支撑其运转的设施、仪器与实验室设备。

一、为什么这件事重要

Why this matters

In regulated life sciences manufacturing, equipment is not simply a production asset. Facilities and instruments are core GMP control points, because their condition directly shapes product quality and the integrity of the records that prove it. A missed calibration or a late preventive maintenance task can ripple outward, calling test results into question, disrupting batch schedules, widening deviation investigations and complicating responses to regulators.

在受监管的生命科学制造中，设备不只是生产资产。设施与仪器是 GMP 的核心控制点，因为其状态直接决定产品质量以及证明质量的记录完整性。一次错过的校准或一项迟到的预防性维护，影响会向外扩散：检验结果被质疑、批次计划被打乱、偏差调查扩大、对监管机构的答复变得复杂。

Yet this is precisely the area many manufacturers have left behind in their digital transition. Korea Fujitsu notes that even companies running computerised QMS (Quality Management System) and MES (Manufacturing Execution System) platforms frequently still track equipment maintenance and calibration histories in spreadsheets, paper documents or standalone tools. The result is a fragmented record at the exact point where inspectors expect a clean, traceable audit trail.

然而这恰恰是许多企业在数字化转型中落下的环节。韩国富士通指出，即便是已经运行计算机化 QMS（质量管理系统）和 MES（制造执行系统）的公司，设备的维护与校准历史仍常用电子表格、纸质文档或独立工具来记录。结果是在检查官最期望看到干净、可追溯审计轨迹的地方，记录反而是割裂的。

MasterControl Ax 资产管理界面：设备档案与维护校准日志，含预防性维护与校准任务计划、到期日（图源：mastercontrol.com）

二、平台做什么

What the platform does

MasterControl Ax is a computerised maintenance management system (CMMS) built specifically for life sciences, rather than adapted from general industrial software. It brings the entire asset lifecycle into a single environment, covering:

Asset visibility: equipment status and location viewable in one place.

Calibration control: calibration schedules managed and tracked against due dates.

Preventive maintenance: plans set on either a time basis or actual usage.

Work execution: work orders raised, assigned and closed within the system.

Service history: a consolidated, traceable record of all maintenance and service activity.

MasterControl Ax 是一套专为生命科学构建的计算机化维护管理系统（CMMS），而非从通用工业软件改造而来。它把资产全生命周期纳入单一环境，涵盖：

·　资产可视化：设备状态与位置在一处查看。

·　校准控制：校准计划按到期日管理与跟踪。

·　预防性维护：计划可按时间基准或实际使用量设定。

·　工单执行：工单在系统内发起、分派与关闭。

·　服务历史：全部维护与服务活动的整合、可追溯记录。

By replacing scattered logs with a unified record, the platform is designed to reduce the risk of overdue tasks, shorten the time needed to assemble evidence for audits, and give quality teams a reliable view of asset readiness before batches are released.

通过用统一记录取代分散的台账，该平台旨在降低任务逾期的风险，缩短为审计汇编证据所需的时间，并让质量团队在批次放行前对资产就绪状态有可靠视图。

MasterControl Ax 工单执行界面：制备液相色谱系统的维护工单与任务清单（图源：mastercontrol.com）

三、补齐数字栈

Completing the digital stack

The launch also signals a broader strategy. With Ax, Korea Fujitsu now offers three pillars of the MasterControl platform in Korea: Qx for quality, Mx for manufacturing and Ax for assets. Together they allow life sciences companies to connect quality events, production records and equipment data on a common platform, closing a gap that has historically forced teams to reconcile information across disconnected systems during investigations and inspections.

此次上线还释放出更宏观的战略信号。随着 Ax 落地，韩国富士通在韩国现已提供 MasterControl 平台的三大支柱：质量（Qx）、制造（Mx）与资产（Ax）。三者共同让生命科学企业在同一平台上关联质量事件、生产记录与设备数据，填补了一个历史性缺口——以往调查与检查时，团队不得不在互不连通的系统之间反复核对信息。

四、管理层观点

Leadership view

Kyung-joo Park, CEO of Korea Fujitsu, said the launch is significant because it widens the scope of digital operations for life sciences companies from quality and manufacturing into facilities and asset management. "Korea Fujitsu will strengthen digital operating systems across quality, manufacturing and asset areas based on the MasterControl platform expanding to Qx, Mx and Ax," Park said, adding that the company will continue to support customers in responding more effectively to regulatory inspections while using accumulated data for analysis and AI-based decision-making.

韩国富士通首席执行官 Kyung-joo Park 表示，此次上线的意义在于把生命科学企业数字化运营的范围从质量与制造扩展到设施与资产管理。他说：「韩国富士通将基于 MasterControl 平台扩展至 Qx、Mx 与 Ax，强化质量、制造与资产领域的数字化运营体系。」他还补充，公司将继续支持客户更有效地应对监管检查，并利用积累的数据开展分析与基于 AI 的决策。

五、值得观察

What to watch

For Korean manufacturers scaling biologics, biosimilars and contract manufacturing capacity for global markets, the ability to demonstrate equipment control under international GMP scrutiny is becoming a competitive requirement rather than an operational nicety. The key questions now are how quickly early adopters move asset records off spreadsheets, and whether a single connected data layer across quality, manufacturing and assets translates into faster inspections and fewer equipment-linked deviations.

对面向全球市场扩大生物药、生物类似药与合同生产能力规模的韩国制造商而言，在国际 GMP 审查下证明设备受控，正从运营加分项变成竞争门槛。当下的关键问题是：早期采用者会以多快速度把资产记录从电子表格迁移出来，以及打通质量、制造与资产的单一数据层，能否转化为更快的检查通过与更少的设备关联偏差。

The stated ambition to apply that accumulated data to analytics and AI-driven decisions points to where the next phase of competition in Korean GMP operations is likely to play out.

将积累数据用于分析与 AI 驱动决策的明确意图，指出了韩国 GMP 运营下一阶段竞争的落点。

资料来源：BioPharma APAC（2026-10-06）；产品界面图来自 mastercontrol.com。