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Medical devices

Critical Software & SKAN AG: Transforming Automation in Aseptic Processing Through Agile Innovation

Celebrating a partnership in digital transformation and lean agile excellence.

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In the fast-evolving world of digital transformation, synergies between companies are key to unlocking growth and operational excellence. The relationship between Critical Software and SKAN AG (SKAN) demonstrates what collaboration, shared vision, and alignment can achieve in the pursuit of technological and cultural innovation. From the early days of pilot projects to comprehensive consulting engagements, the partnership has matured into a model of strategic cooperation in the automation and pharmaceutical technology sectors.

The partnership began in 2022 in the automation domain, focusing on improving workflows and making pharmaceutical processes more efficient. SKAN, as an isolator manufacturer, plays a pivotal role in ensuring aseptic containment and compliance with GMP (Good Manufacturing Practices) standards, particularly in the integration of automated filling lines and barrier systems.

The foundation of the Critical Software–SKAN partnership lies in mutual trust, built through successful project delivery, consistent communication, and a shared commitment to continuous improvement. Team members from both organizations have demonstrated openness and appreciation, fostering a culture that values both results and collaborative journeys. This trust is further reinforced through regular debriefs and retrospectives, where lessons learned are shared and future improvements are identified together.

Embracing Lean Agile and Digital Transformation

The partnership between Critical Software and SKAN AG has evolved through complex, fast-changing projects driven by real-world constraints and shifting priorities. Like many long-term collaborations, it has not always been seamless — but it has been highly productive, especially when both teams embraced transparency and problem-solving.

Technically, the projects span multiple domains. Teams have worked with Siemens S7 and Allen-Bradley PLCs, developed interfaces using ReactJS, and integrated automation systems with isolator technologies. This work required deep technical expertise and close collaboration across disciplines: automation engineers and software developers, UX designers, and scrum masters all played essential roles.

One such initiative is the Sphere Health project, aimed at delivering state-of-the-art aseptic solutions tailored to customer requirements. These solutions required formal certification, demanding that all development and testing activities comply with rigorous standards such as GAMP5. To meet this challenge, Critical Software scaled multidisciplinary teams and adopted Agile practices supported by Continuous Integration/Continuous Delivery (CI/CD) pipelines. The working model was co-designed with the client and included a dedicated knowledge academy to onboard new team members and maintain consistent quality.

Key Metrics and Milestones

  • Fast and effective onboarding between Critical Software and SKAN teams

  • Pilot project validation that helped test and refine new approaches

  • Team structures adapted over time to meet evolving project needs

  • Certified deliveries aligned with GAMP5 and other regulatory standards

These experiences are now shaping how both companies approach future initiatives, particularly as they explore digital twins, remote collaboration, and more modular, scalable solutions. The focus remains on building practical, reliable systems that meet real operational needs.

Looking Ahead

Although the partnership initially focused on cross-functional teams working in PLC development, it has since expanded to include technologies such as 3D, ReactJS, and UX, among others—each contributing to holistic solutions. Scrum masters, engineers, and consultants coordinate product strategy, sprint planning, retrospectives, and team ceremonies, ensuring continuous and meaningful progress.

Rooted in mutual respect, this partnership promotes adaptability, active listening, and continuous innovation. Both companies recognize that true transformation is as much about people and culture as it is about technology. Workshops, design reviews, and continuous feedback loops help ensure that products are intuitive and deliver real value to end users. As a result, Critical Software and SKAN consistently deliver high-impact solutions that meet regulatory standards and exceed client expectations.

This collaboration goes beyond a successful project—it represents a culture of appreciation, open communication, and the pursuit of excellence in both technology and teamwork. Expressions of gratitude, timely feedback, and genuine camaraderie define a partnership that is as rewarding personally as it is professionally.

As the teams continue working together on digital transformation, lean agile adoption, and modular product development, the future promises deeper collaboration, greater impact, and continued innovation. With the expansion of digital twins and AI in pharmaceutical automation, the Critical Software–SKAN partnership is well-positioned to lead the next generation of intelligent, secure solutions.

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