扩大制药行业制造执行系统（MES）的战略力量

Closing post-launch MES gapsto unlock future business value The pharmaceutical industry is at an inflection point: regulatory expectations are rising, product complexity is increasing, and the pace of technological change is accelerating. In thisenvironment, MES must be more than compliant, it must be intelligent, agile, and aligned with strategic business goals. Avoiding the MES post-launch plateau Many pharma organizations face a critical challenge post manufacturing execution system(MES) deployment: value delivered at the time of launch is often limited to technicalfunctionality, falling short of the broader, business-aligned impact the system is capable ofdelivering.This gap is often the result of an implementation plan that ends at go-live, as well as an technologies and integration with other core business systems enables MES to become astrategic asset that can drive efficiency, agility, and innovation.To unlock MES’s full potential, pharma organizations must rethink the system’s role, applications, measurement, and possibilities: Deployment is not the finish line—it’s thestarting point. MES is not a static IT tool or compliance checkpoint, but a driver of operationalexcellence and a catalyst for innovation. The purpose of MES is not just to stabilize systems,but to actively create value across the business.In this paper, our experts examine how pharma companies, as well as biopharma and other life insufficient measurement system. While the initial MES deployment is often well-resourced,the post-implementation phase is frequently underemphasized, leading to underutilizedfeatures, limited user engagement, and missed opportunities for operational improvement.At the same time, the role that MES plays in the business is evolving. Once seen as a static ITsystem that ensures compliance and manages execution, the application of advanced sciences organizations, can embrace this new vision of MES to avoid the post-launch plateauand harness the full power of their investment. Beyond uptime: Turning MES into a performance engine with strategic KPIs The true measure of MES success lies not in its deployment,but in the value it continues to generate over time. Yet, manyorganizations lack a standardized approach to measuring thisvalue. Deviation reductionis another high-impact area. Modernpharmaceutical quality systems leveraging MES technologyhave been shown to reduce investigation cycle times by45-60% and decrease overall quality deviations by 25-40%.1 For example, MES can help prevent deviations by enforcingprocedural compliance, flagging anomalies in real time, andproviding structured data for root cause analysis. However,this potential is only realized when the system is activelymonitored, and its data is used to drive continuousimprovement. Manufacturing sites that have implementedMES dashboards to track deviation trends see significantreduction in repeat deviations shortly after implementation. For example, organizations focus on system uptime orcompliance metrics, overlooking the operational andstrategic indicators that truly reflect MES impact. Thisreinforces the limited role of MES as a static compliance toolrather than a dynamic driver of business performance. It alsomakes it difficult to demonstrate return on investment or tojustify further optimization efforts. Effective MES governance begins with identifying the rightmetrics—meaning those that align with business goals andreflect the system’s role in driving performance. Somestrategic KPIs may include: batch release cycle time, right-first-time rates, deviation frequency and resolution time,operator productivity and recipe or MBR change cycle time. Generating sustained value from an MES needs to be seen asa continuous process, supported by regular audits, userfeedback loops, and agile enhancements. KPIs should also bereviewed regularly at the leadership level and used to informdecisions about system enhancements, training needs, andintegration priorities. For example, one of the most frequently cited metrics isbatch release cycle time.In many pharma organizations, thisprocess can take days or even weeks due to manual review,incomplete data, or fragmented systems. A mature MESimplementation, especially one integrated with the qualitymanagement system (QMS) and laboratory informationmanagement system (LIMS), can significantly reduce thiscycle. For example, by enabling real-time data capture andcontextualized batch records, manufacturing sites can cutbatch release times substantially, freeing up QA resourcesand accelerating product availability. Unlocking the value of MES When paired with other digital systems and advanced technologies, MES can accelerate production, improve quality, cut costs, and reduce errors. But, without the right metrics and a structuredmeasurement approach, these gains often go unquantified or even unrealized. Embedding strategic KPIs into MES performance tracking enables pharma organizations to capture and maxim