ISPE iSpeak 博客：从数字化转型到以人为本的生产——为制药未来设计协作型工作空间

Yet technological progress alone does not guarantee organizational success. Across our industry, organizations continue to face similar challenges: burnout, resistance to change, knowledge loss during restructuring, widening skills gaps and difficulties integrating new technologies into everyday work. Technology evolves exponentially, while people adapt more gradually. The real challenge is therefore no longer simply achieving digital transformation, but designing organizations where technology empowers people rather than overwhelms them.

This is precisely the vision behind Industry 5.0, introduced by the European Commission. While previous industrial revolutions focused primarily on productivity and automation, Industry 5.0 builds on digital transformation by placing human-centricity, resilience and sustainability at the center of industrial development, strengthening societies and social models.1^, 2 It asks a simple but powerful question:

How can technology augment human capabilities while improving well-being, trust and long-term organizational resilience?

This vision is already reflected within the ISPE Baseline^® Guide: Pharma 4.0™ (First Edition),3 which expands digital transformation beyond technology to include people, organization and culture. One practical way of translating these principles into everyday organizational practice is to intentionally design collaborative workspaces, workplaces where technology, people and organizational culture reinforce each other instead of competing with each other.

In the author’s experience, four organizational functions already exist inside every pharmaceutical company that can make this happen: leadership, quality, human resources, and employee participation through works councils or equivalent representative bodies (Figure 1). Together, they become the architects of a truly human-centered organization.

Figure 1. Key enablers of human-centric organization.

Leadership: Creating Purpose Before Technology

Digital transformation rarely fails because of technology. More often, it fails because people do not understand why change is happening or do not trust the process. Leadership, therefore, becomes much more than managing projects or approving investments. Leaders create a sense of purpose, shape organizational culture and establish psychological safety. They communicate not only what is changing but also why it matters.

Industry 5.0 reminds us that organizational culture is not created through strategy documents alone. Culture is shaped every day through leadership behaviors and interactions. Founders establish it. Executives reinforce it. Managers demonstrate it. Role models make it real. Employees experience it.

These three elements form the foundation of collaborative organizations:

• Purpose provides direction.
• Values guide how decisions are made.
• Empowerment enables people to contribute.

Transformation therefore does not begin with technology. It begins with leadership, because leaders ultimately set the culture that determines whether technology becomes merely another tool—or a catalyst for trust, collaboration and meaningful change.

LEF Leadership (lef in Dutch) refers to leading with courage, authenticity, and taking conscious risks instead of relying on rigid management structures. This term and related concepts appear in several contexts, especially in the Netherlands describes leadership as accountable and fun—a simple framework that helps translate organizational strategy into everyday behaviors (Figure 2). Be bold enough and dare to lead.4

Figure 2. LEF Leadership

Purpose answers the question "Why do we act?" It connects people to a shared vision, continuous improvement, sustainability and long-term value creation.

Values answer "How do we act?" In pharmaceutical manufacturing these include integrity, patient safety, trust, knowledge sharing, accountability, inclusion, resilience and openness. They guide decisions when technology alone cannot provide the right answer.

Empowerment answers "What do we enable?" Leaders create environments where people feel psychologically safe to speak up, learn from mistakes, take ownership and continuously improve. Innovation flourishes when employees feel trusted rather than controlled.

Futhermore, future leaders will require more than technical expertise. While intelligence remains essential for solving complex problems, emotional intelligence enables collaboration, empathy and trust. Increasingly important is also values-based leadership—sometimes described as spiritual intelligence—which aligns decisions with ethics, long-term purpose and the well-being of both people and society.

Quality: Connecting People, Knowledge and Decisions

Quality has always protected patients. Its future role is becoming even broader. Historically, quality organizations focused primarily on compliance, inspection readiness and deviation management. While these responsibilities remain essential, modern quality organizations increasingly act as connectors across manufacturing, engineering, digital teams and regulatory functions.

Quality becomes a collaboration hub (Figure 3). Instead of operating through organizational silos, quality enables integrated decision-making by connecting knowledge management, risk management, data integrity and continuous learning. Thus, quality is evolving beyond compliance acting as a collaboration hub uniting people, technology, knowledge, and business.

This evolution reflects one of the central principles of Industry 5.0: trustworthy technology requires trustworthy organizations and human centricity.5^, 6

Figure 3. Quality as a Collaboration Hub.

Artificial intelligence (AI) can analyze data faster than humans, but people remain responsible for interpreting information, keeping oversight, applying ethical judgement and making balanced decisions. Quality therefore safeguards not only product integrity but also organizational integrity. Knowledge sharing, transparent communication and cross-functional collaboration become just as important as procedures and documentation. Breaking organizational silos creates more resilient systems, improves decision quality and ultimately strengthens patient safety. Perhaps most importantly, good quality is not a cost.

A human-centric quality culture is often perceived as requiring additional resources, bureaucracy, or higher operational costs. However, evidence increasingly suggests the opposite. Organizations that invest in mature quality systems reduce the long-term costs associated with deviations, investigations, recalls, rework, and supply disruptions by preventing problems before they occur.

The ISPE Advancing Pharmaceutical QualityTM (APQ) Guide: Cultural Excellence reinforces this perspective by describing quality culture as a key determinant of sustainable quality performance and patient-focused outcomes. Rather than viewing quality as a control mechanism, the Guide positions culture as the foundation that enables transparent problem escalation, employee engagement, operational excellence, and continuous improvement.6

This balanced view aligns closely with the human-centric philosophy described throughout this blog. When leadership empowers employees, Quality facilitates learning and knowledge sharing, HR develops future-ready capabilities, and employee participation strengthens trust and adoption, organizations are better positioned to achieve both effectiveness—doing the right things—and efficiency—doing things right. In that sense, collaborative workplaces are not only better places to work; they are also more resilient, more innovative, and ultimately more cost-effective

As demonstrated by both US Food and Drug Administration publications and modern quality management frameworks, investing in prevention, knowledge management and effective quality systems reduces the overall cost of poor quality while improving operational performance.7^, 8

Human Resources: Building a Workforce Ready for Continuous Change

Technology changes rapidly, and people need opportunities to grow alongside it. This makes human resources one of the most important strategic partners in organizational transformation. Across the pharmaceutical industry, restructuring has become increasingly common as organizations respond to economic pressures, geopolitical uncertainty and rapid technological innovation.

Too often, however, companies reduce headcount only to find themselves, months later, searching for employees with new digital capabilities. This cycle is costly, not only financially, but also in terms of lost knowledge, organizational stability and employee trust. Rather than continuously replacing people, organizations should invest in continuously developing them.

Human resources can lead this transition by aligning workforce capabilities with future business needs, creating structured learning and development pathways, supporting cross-functional collaboration and embedding lifelong learning into organizational culture (Figure 4).

Figure 4. Human Resources as a Strategic Enabler.

ISPE has already recognized this need through its Pharma 4.0™ model, demonstrating that successful digital transformation depends as much on workforce capability as on technological capability.9 The future workforce will require technical literacy, AI awareness, cybersecurity knowledge and analytical thinking. Equally important will be creativity, adaptability, resilience, curiosity and continuous learning.10 The organizations that invest in people today will be the ones best prepared for tomorrow.

Employee Participation: Turning Dialogue into Trust

Perhaps the most overlooked contributor to successful transformation is employee participation. Whether through works councils, employee representatives or other consultation mechanisms, involving employees early on fundamentally changes how transformation is perceived. When organizations announce automation, artificial intelligence or robotics, many employees immediately ask one question:

"What does this mean for me?"

If people believe technology exists only to replace them, resistance becomes inevitable. If they understand that technology will help them develop new capabilities and perform more meaningful work, the conversation changes completely. Employee participation ensures that collaboration is not only technological but also cultural.

Digital transformation is ultimately a human transformation. New technologies change not only processes but also the way people work, collaborate, and experience their jobs. If employees are not actively involved in that transition, uncertainty and resistance can quickly undermine even the best digital strategy.

Works councils (or other employee representative bodies) play a unique role in bridging this gap. Rather than acting only as consultation bodies, they can become strategic partners in designing collaborative workplaces by bringing the voice of the workforce into organizational decision-making from the earliest stages of change (Figure 5).

Figure 5. Works Councils as a Strategic Partner

Their contribution extends far beyond compliance with labor legislation. Works councils encourage transparent communication between leadership and employees, facilitate ethical discussions around AI, automation, and digital technologies, and ensure that transformation considers not only productivity but also employee well-being, fairness, and long-term employability. In this way, inclusivity and psychological safety become an integral part of system design rather than afterthoughts. Early consultation helps organizations identify concerns before they become resistance, while co-designing new workflows can strengthen employee ownership and support adoption across the workforce.

In a human-centric organization, employee participation is therefore not an obstacle to organizational strategy or innovation but an accelerator of sustainable change. By fostering dialogue, strengthening trust, and ensuring that employees remain part of the decision-making process, works councils help organizations move beyond technology implementation toward genuine cultural transformation.

As the European Commission emphasizes in its Industry 5.0 vision, resilient organizations are those that place people at the center of innovation.1^, 2 Works Councils help translate this principle into daily practice by ensuring that collaboration is not only technological, but also cultural.

Conclusions

Technology will continue advancing faster than ever before. AI will become increasingly integrated into pharmaceutical manufacturing, automation will expand, and data will become even more valuable. Yet competitive advantage will depend less on technology itself and more on an organization's ability to integrate people, knowledge and technology into one collaborative environment.

Four elements will be central to this transformation:

• Leadership provides purpose
• Quality builds trust
• Human resources develops future-ready capabilities
• Employee participation fosterss engagement and dialogue

Together these elements transform workplaces into integrated environments where responsible decision-making shape culture, empower people and strengthen organizational resilience. The future of pharmaceutical manufacturing will not be defined solely by smarter technologies. It will be built in workplaces that promote engagement, well-being and continuous learning—because sustainable innovation and long-term performance ultimately begin with people.