3 Must-Haves for Successfully Deploying Enterprise Systems to Increase Production Throughput

Executive Summary

Despite valid concerns to ensure sites have the flexibility to meet local needs while still maintaining the rigor of pharmaceutical quality and regulatory compliance, the long term value of deploying an enterprise-wide system is clear. With an enterprise manufacturing ecosystem in place, your organization is aware of all of the manufacturing processes, knowledge, and capabilities that allow it to collaboratively improve product quality, deliver new therapies faster, and streamline global capacity. 

You understand the value, so now what do you need to actually deploy at scale? There are three main requirements we recommend in order to scale globally, quickly and thoughtfully.

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1. Establish an Enterprise Culture

The first step in any global enterprise deployment is to foster an environment of communication, collaboration, and knowledge-sharing across sites. When teams from different geographies and functions come together to share insights, challenges, and best practices, the organization as a whole becomes stronger and more innovative. Effective channels that facilitate this exchange of knowledge can include forums, social gatherings, and digital platforms.

Examples of successful avenues from our own projects:

• Identify an internal change agent at each site or team to be an ally for the deployment and share success stories with others across the organization
• Create a Slack channel, Teams channel, Monday,com board, Trello board or any common open forum where any questions, thoughts and ideas are welcome 
• “Show and tell” - host lunch and learn style sessions for sites and teams to share wins with regards to the deployment
• Find a problem that multiple teams experience and task them to solve it together
• Leverage resources such as graduate rotational leadership programs that don’t have an established “this is mine don’t touch it” mentality to drive cross functional projects.

We advise customers to remember that these channels are ineffective without alignment on and communication of the clear goal(s). In these forums, it’s recommended that organizations openly define their goals. Determine if the goal is one MES for any given end-to-end therapy across sites; one MES for just buffers across all sites; one LES for a set number of sites, etc. In addition, teams must provide the “why.” Bring the full team into the problem that needs to be addressed to ensure alignment. 

2. Define Enterprise Governance

The next step is to ensure that effective enterprise deployment governance and procedures are set. This ensures that they match manufacturing operations needs alongside global quality and regulatory requirements that are compliant and may be adaptable and leveraged by sites. Ensuring alignment proactively between quality and manufacturing operations ensures an ongoing manufacturing improvement journey. 

In order to do this, organizations must form a center of excellence to ensure cross functional alignment between sites that are ready to adopt new processes and technologies as they are rolled out. Processes such as manufacturing batch records and recipes, material and equipment master data, integrations, and operational SOPs can all be created for sites to leverage. This not only accelerates time to market for new products from new drug discoveries but also enhances business continuity for the organization by providing flexibility to respond to emergencies and opportunities with agility and confidence.

3. Develop a Unified Global Systems and Solutions Architecture

The last step towards effective enterprise deployment is the establishment of a unified global systems and solutions architecture. This means having a vision and framework for ensuring that all sites, regardless of their geographical location, have access to the same type of digital systems. As a starting point, ISA 95 can be used as a baseline for this guidance to provide what types of processes and systems are needed individually for each site. The next step is to ensure that each system is scalable. The processes and solutions need a robust infrastructure that scales to allow for seamless adaptation to changing requirements, business demands, and technological advancements. With pressures from drug discovery acceleration and more recent mergers and acquisitions, being able to immediately leverage and apply global infrastructure and solution architecture is paramount. The only path forward is to apply a cloud-native and capable technological solution that can quickly spin up new sites and teams for new demands.

Conclusion 

The journey towards effective enterprise deployment governance in pharmaceutical manufacturing is both challenging and rewarding. By focusing on building a unified global architecture, prioritizing scalability, and enabling immediate ways to apply and leverage the system, organizations can easily foster collaboration and knowledge sharing across global sites while maintaining a commitment to strict compliance and quality controls, This strategic approach not only enhances operational efficiency and compliance but also significantly boosts the organization's ability to innovate and respond to the dynamic global market.

It is said that the deployment of any system is an evolution, not a revolution. By taking enterprise deployment considerations into the implementation within a single site, future site deployments will be able to benefit from faster projects, ensuring consistent quality, and creating better tracking of manufacturing processes.

Ready to deploy at scale? Our team can help you work through the challenges and help your organization drive innovation forward while improving quality, standardizing processes and boosting efficiency across sites and teams. 

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