Currents

Governance:

Define Leadership, Ownership, and Stakeholders Early

Without clear governance, process globalization initiatives often fail, because they lack clear direction. Before jumping into revisions without a clear plan, align on:

• Leadership: Who is the executive sponsor responsible for establishing objectives and ultimate decision rights?
• Ownership: Who are the people responsible for process success at the global and local levels?
• Reviewers: Who are the team members involved who need to provide input? What other functions need to be included?
• Infrastructure: Do you have a documentation framework? What about standard templates?

Establishing governance early prevents stall points later in the process. Without buy-in across the organization, there will be delays with decision rights, approval, and rollout.

Landscape:

Inventory Current Documentation to Establish the Baseline

Transformation begins with visibility. It starts with identifying and reviewing:

• “Representative” global, regional, and local SOPs
• Work instructions and supporting documents
• Templates, forms, and decision trees
• Approval pathways and ownership structures
• Relevant systems and functionality globally, as applicable
• Audit/inspection results
• Training, as applicable

Following the initial inventory review, we complement this with stakeholder discussions to surface and align on critical pain points.

This process reveals:

• Duplication and overlap
• Inconsistent terminology
• Misalignment between systems, documentation, and execution
• Bottlenecks in adoption

Organizations are often surprised by the scale of redundancy uncovered at this stage. Once we understand the landscape and pain points, we can map out overall document structure and develop an overall, prioritized document-level plan for the project. This may include retiring and combining as well as identifying the need to create new documents.  The goal is logical groupings based on priority and audience.

When planning how to group documentation and/or workstreams together, consider:

• Overall inherent risk of activities
• Priorities / primary functions of the Medical Affairs function
• Touchpoints/interconnectivity with other processes

With current state understood, we can begin by establishing a global “floor” of requirements and process applicable for the organization.

Outline:

Identify Global Baseline and Map Processes

Start simple and build as you go. Once you have a plan, you can begin developing detailed outlines for your high-priority documents.

This phase includes meeting with stakeholders for:

• Cross-regional process mapping
• Pain-point validation workshops
• Identifying document audience
• Defining roles and responsibilities
• Identification of non-required or non-value-added steps
• Process start and end points
• Documentation of justified local exceptions

Once outlines are complete and stakeholders are aligned on a global “floor” for the organization, you can begin drafting simplified SOPs. This is where simplification becomes tangible.

Buy-In:

Ensure Implementation & Manage Change

The most well-crafted SOP in the world is useless if stakeholders don’t know about it. The process doesn’t stop after the SOP is approved. Thoughtful rollout communication and training is key for success. Roll-out implementation includes:

• Identifying audience: Who is impacted by the process change?  To what degree? Process owners need to know who is involved and the audience need to know how their job is changing.
• Right-sizing training: What level of training is necessary?  Effective training is not one-size-fits-all. Balance training overload by making sure your training is aligned to the process risk.
• Timing: When should we rollout documents and training? Plan your release cycles out for the year, so individual workstreams can plan accordingly. Adjust accordingly in order to spread training requirements throughout the year and communicate appropriately to impacted personnel.

Organizations that invest in structured enablement see:

• Faster uptake
• Reduced deviation rates post-launch
• Improved onboarding consistency

Adapt:

Leverage Global Network of Stakeholders to Enable Change

Most SOP standardization efforts fail not during redesign — but over time.

Without defined metrics and structured review cycles, documentation complexity can return:

• Local exceptions expand
• Approval layers creep back
• Templates diverge / narrative “sprawl”
• Update timelines lengthen
• Informal workarounds re-emerge

Sustainable simplification requires disciplined measurement as well as centralized control.

By treating simplification as an ongoing governance practice, organizations prevent complexity from re‑accumulating and reinforce the behaviors required to operate effectively at scale.

Standardization succeeds when structure supports it.

Learn:

Use the Model as an Opportunity for Continuous Improvement

Changing behavior in a global organization is hard. The good news is that once global processes are in place, you have a connected network of people, processes, and systems that can be leveraged to drive and sustain performance across the organization.

Measurement plays a critical role in reinforcing new ways of working and identifying opportunities for improvement. By establishing clear metrics and feedback mechanisms, organizations can move beyond implementation to continuous refinement of their processes and governance model. See graphic/table for potential measurements that might be helpful to your organization.