When implementing a new process in life sciences, a major initial constraint is ensuring that regulatory requirements are met — hence, the focus is on compliance. But for an optimized end-to-end process, it is critical to move beyond compliance to drive efficiency, performance and sustainability. Your organizational culture has a key role to play, and change management is necessary to shift implementation mindsets from siloed to end-to-end process design.
Compliance as the basis of process setup
When life sciences organizations set up a new process, meeting compliance requirements is mandatory. For example, in the field of labeling, global processes are designed with a goal of developing compliant labeling documents to ensure the safe use of a drug or medical device. The frequency of FDA audits and inspections, the costs of product recalls due to label inadequacy and the importance of patient safety drive the need to develop a stringent compliance framework.
Because of this, life sciences organizations tend to start by focusing more on monitoring compliance than on optimizing the end-to-end process. Although this approach is critical to meet the compliance goals, it also leads to a few challenges:
- The initial focus on compliance-centered metrics — e.g., timelines, content quality or deviations — deprioritizes the tracking of end-to-end process execution, which could offer significant insights into improvements and create value for the organization.
- Since countries typically face different local regulations and requirements, regional differences are a central theme to take into consideration. Continuous improvement is significantly more difficult to implement when the ways of working between headquarters and countries, including communicating, collaborating and escalating challenges to leadership, are disconnected.
- For large life sciences organizations, siloed metrics across the organization provide a division- or geography-centric view. Reconciling those outcomes to offer a holistic view is key in enabling the organization find root causes and pathways to increase efficiency and ensure compliance sustainability.
Moving beyond compliance to focus on end-to-end process optimization
Once a solid initial process for meeting regulatory and compliance requirements is set, organizations should shift the ongoing focus to end-to-end process optimization to maximize value creation. Objectives include increasing efficiency and shortening the cycle time for the end-to-end process execution, improving quality and efficiency outcomes, and saving costs.
Top approaches for end-to-end process optimization include:
- Assigning an end-to-end process owner. This process owner must engage a cross-functional team of individuals, each of whom has a stake in the success of the process. The team must build a broad understanding of the process from start to finish and share common objectives.
- Designing a risk-based approach to monitor the process implementation from end to end. Identify and classify the types of risks to the organization at every step; prioritize them and develop mitigation strategies.
- Refining the organization’s set of metrics to increase visibility to the end-to-end process performance. For example, focus on identifying end-to-end process trends over time and analyzing underlying root causes. Obtaining more insights on the global picture will prompt more ideas about where to focus improvement efforts.
- Using systems and technology to increase the process efficiency. For example, implement a structured content authoring and management tool to move away from manual authoring processes involving siloed and duplicative tasks. Optimizing the connectivity between document management systems used during the label development life cycle is a complex challenge that, if solved, could yield substantial benefits.
- Fostering local empowerment and accountability to increase the performance of a decentralized model. Encourage local teams to share lessons learned and best practices. Developing regional interactions to reflect on common themes and refining methods for escalation — paired with solid governance — could add significant value.
Drive the organizational mindset as an overarching theme
Leadership plays a significant role in fostering the adoption of process optimization as a company standard. Leaders are responsible for ensuring that process optimization is incorporated in regulatory strategic objectives and driving the corporate culture and teams’ mindset to focus on a holistic, end-to-end process.
It is crucial to develop a change management plan, widely communicate the strategic value of the objectives, and conduct comprehensive training and continuous improvement programs.
Although meeting compliance requirements represents an overarching constraint, moving from siloed components to an end-to-end process vision and developing optimization pathways are key to delivering value to your organization.
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