For life sciences companies, orchestrating end-to-end business processes for HCP engagements is critical. And now, more than ever, choosing and implementing the right compliance software is just as important. Once a software platform has been selected, the best way to maximize investment is to implement at methodical and detail-oriented plan.
Since users of compliance software in life sciences organizations sit in silos across the enterprise, your plan should strategically involve stakeholders in compliance, marketing, sales, IT, finance, medical affairs, and legal teams.
Here are 10 recommendations to ensure success:
1. Ensure senior management buy-in.
To support any initiative, senior leaders need to understand the value, implementation strategy, and the actions they need to take to facilitate the integration into enterprise-wide operations. With senior management as champions, you will receive budget support, critical counsel, and assurance that the implementation aligns with enterprise-wide goals.
2. Establish a clear road map.
Focus on an enterprise-wide road map with guiding principles rather than features and functionality. These principals will guide you in making sure the implementation is neither overly-designed nor too simplistic.
This road map will ensure a smooth rollout and enthusiastic stakeholder response.
3. Understand your current business process.
Assess what systems or tools are in place now, where there are gaps, and where there are opportunities for improvement. This assessment guides decision making.
Additional considerations include:
- Prioritizing global versus local needs
- Addressing compliance requirements
- Integration points across your enterprise ecosystem
4. Establish a governance infrastructure.
To overcome any risks to the project, establish a governance infrastructure. Strong governance includes participants from different sides of the business. If the implementation is global, include stakeholders from different countries and markets to balance and reconcile different needs and priorities.
5. Manage decision points.
While your governance team will advise and address higher-level decisions, the project team will provide critical oversight. Task this group with managing vital decisions throughout the implementation process.
6. Drive execution via a central Project Management Office
Your Project Management Office (PMO) will serve as a central coordinator for the entire implementation. Think of it as the central nervous system of this undertaking. It is a singular voice for consolidated communication up through and even after deployment, including management status reports, risk mitigation scenarios, budget and timeline updates, and change requests.
7. Organize the project in distinct workstreams.
When gearing up for implementation, various workstreams need to collaborate to avoid delays. Some suggested workstreams to consider are:
The project team addresses how the software will perform concerning data privacy and fair market value. This team also focuses on functional areas such as processes, training, systems deployment, and master data management, inclusive of collection, privacy oversight, and analysis.
IT manages the end-to-end workflow. This includes architecture and framework issues about data privacy, Fair Market Value benchmarking, and certification protocols.
IT also supports configuration & testing. During this phase, it is crucial to develop a step-by-step communication plan that addresses project and change management elements with the organization and users of the system.
User acceptance testing is a pivotal workstream that verifies that the software supports the needs of the users. Picking the right participants for the user acceptance testing will position them as advocates for the solution after launch.
8. Create a change management process.
As the software is implemented and after it is installed, change is inevitable. New features, functionality and upgrades are typical throughout a software system’s lifecycle. In addition, there may be new commercial or regulatory requirements that require implementation to remain compliant. A defined change management process will minimize interruptions
9. Evangelize the opportunity.
Share the news with your colleagues! Help them to feel excited about the changes underway. Listen to their questions and be prepared to answer them. Determine how to handle feedback and always follow-up appropriately. All of this will create more positivity and affect the system's adoption.
10. Manage for ongoing success.
With implementation completed, benchmarking to your guiding principles will require a protocol of continued refinement and improvement. Ongoing training provided by your compliance software partner will allow you to refine your use, drive user engagement, and capitalize on your software investment.