Digital transformation offers numerous opportunities, such as improving efficiency and increasing customer satisfaction. But it also opens up completely new areas of business. Innovation also means being able to react quickly to changes, whether of a technical or organizational nature. This is a prerequisite, a benefit and a challenge at the same time.

In the Life Science industry, as in other regulated industries, validated environments pose particular challenges for digital transformation.

Definition

Digital Transformation goes beyond the mere digitization of analogue information (business process automation, digitization of paper-based documents) and encompasses the comprehensive change of business models, processes and organizational structures in order to adapt to the digital future and gain competitive advantages. Digital Transformation therefore also takes into account aspects such as new business models, cultural change and technological integration.

Validated environment means precisely defined (digital) business processes and IT systems in order to be able to predict and control the quality of the products. This also includes precisely defined and compliant business processes and requirements for the introduction and modification of the validated environment itself.

Computerized System (CS) refers to the (validated) combination of business process, people and underlying IT system(s).

The Challenge

In validated environments, numerous conflicting objectives arise from the traditional contradiction of “quality” vs. “flexibility” against the backdrop of digital transformation: the business processes and IT functions defined in the interests of predictability must be adaptable at short notice and flexibly for better innovation capability. The overhead of a CS validation process, as it is still often practiced today, stands in the way of this.

Approaches/opportunities to address this conflict of objectives

In addition to the need to involve and engage stakeholders and affected parties on the path to digital transformation, new methods and technologies are opening up new opportunities to overcome previous showstoppers.

Organizational Change Management (OCM)

Organizational Change Management looks at the methods and processes required to successfully plan, implement and monitor changes in an organization.

The aforementioned challenge of digitally transforming validated development environments and thus making them more flexible and efficient while maintaining the required traceability and quality, can ultimately be almost disruptive for those involved. The resulting benefits for everyone involved must be explained and communicated. The necessary trust and understanding must be created that the desired changes will actually be successful. This is the only way to overcome the resistance caused by uncertainty and fears.

Digital Transformation means numerous changes. These include changes to organizations, working methods, tools and terminology. Projects in this environment often fail due to simple aspects as different terminology used by the stakeholders involved. For example, the word. “Document” can describe a digitized paper document (Word file) or a User Requirement data record in an Application Lifecycle Management System from a validation perspective.

Process - holistic view and integration

As part of the Digital Transformation, digital technologies are integrated into all areas of a company's business. This involves not only the introduction of new technologies, but also the holistic redesign of processes and products. This redesign opens up new opportunities for integration and the elimination of data silos and media disruptions.

On the way to fully digitized, validated development processes, modern Application Lifecycle Management Systems offer the possibility of streamlining and thus increasing the efficiency of the validation process and ultimately accelerating the entire development process.

This is achieved through the digital management and documentation of the entire development process, from early requirements (first demand) to requirements engineering, solution design, implementation, (automated) testing and release management.

Participating stakeholders from different areas are integrated on a common data base. Individual artifacts (e.g. requirements, functional descriptions, risk definitions) are also subject to a release cycle, just like the final process products. This takes place with full traceability of

•  the change history (audit log)
•  dependencies
•  impacts

The Application Lifecycle Management System is therefore both a development and validation platform. If the sub-processes mentioned are supported by various IT systems, the Application Lifecycle Management system is the integrating factor in the Validation Tool Chain.

Integration of business, development and IT

The holistic view of the product development process described here integrates three key groups of stakeholders: 

• Business
• Development
• IT operations

New methods and tools in the context of Digital Transformation address the challenges that arise from the organizational interfaces and the different focuses of the groups involved:

• Requirements Engineering integrates business or specialists departments and
  development on a shared platform and database.
• DevOps integrates development and IT operations on a shared platform and database for testing, quality assurance and deployment
• Application Lifecycle Management, finally, integrates holistically and thereby also creates a holistic end-to-end view of the process from the first requirement to the final product.

This creates the foundation for an agile development organization geared towards continuous improvement and innovation.

Technology

Ultimately, technology provides the necessary functionality for the above-mentioned integrations. The following tools and functional platforms have already been mentioned in part and are not exhaustive:

• Application Lifecycle Management System
• Automated Testing sytems 
• Application Release Automation platforms
• Continuous Integration and Continuous Delivery platforms
• Cloud Services
• Artificial Intelligence

Compliance

In the past, the fulfilment of compliance requirements and the resulting necessary validation of Computerized Systems has tended to slow down the desired flexibility and innovation through traditional, non-digital or only partially digital validation processes, particularly in the area of development processes.

This is where Digital Transformation with the “Validation Tool Chain”, thus. an integrated chain of processes and tools on a common, consolidated data basis, creates an efficient basis for compliance with regulatory requirements – keyword: quality by design.

Conclusion

Digital transformation is omnipresent. However, the enormous opportunities are offset by at least as great challenges in the practical implementation and associated management of the same.

The technological tools available today make the transformations manageable and in some cases even possible in the first place.

The above list of aspects to be considered and integrated only briefly touches on this complexity. INCONSULT will therefore provide separate articles on selected topics in the coming months as part of this series of articles.