Investing in a powerful software solution can be extraordinarily valuable to your organization, yet the effort is wasted if it is not implemented effectively. To help ensure a smooth and successful implementation process, consider these six best practices.

All enterprise solutions implementations are unique, comprising their own complexities and challenges due to the technological and organizational change involved. However, there are certain requirements that are essential to the success of any implementation project. To improve the likelihood for success in an implementation project, consider the following best practices, based on MasterControl’s 90 percent implementation success rate among life sciences customers.

Best Practice #1: Define Needs and Objectives

Any implementation plan should include specific objectives and deliverables. An objective may be as broad as “Eliminate nonconformities,” or it might be as specific as “Implement a corrective and preventive action (CAPA) process and procedure that automates routing, notification, delivery, escalation and approval of CAPAs and all related documentation while providing a secure, centralized and web-based repository for all CAPA documents.” Often the foundation for these operational objectives is set when purchasing a solution and can be refined during implementation. Establishing objectives allows involved parties to know exactly what to aim for and to direct all efforts toward achieving the objectives.

Key considerations include:

• Know your configuration requirements. Determining which configuration options are appropriate for your requirements both speeds up implementation and enhances user adoption.
• Know who will be using the software. Taking an inventory of all stakeholders clarifies who will be using the new solution and who will be responsible for ensuring that everything runs smoothly.

A good way to start to define your organization’s needs and objectives is to list processes intended for automation, current challenges associated with these processes, people involved with these processes and the benefits expected from automation.

Related: Learn More About Software Validation

Best Practice #2: Get User Input and Executive Sponsorship

Slow user adoption is often a key barrier to implementation success, typically occurring because users don’t see the advantages of automation or because they’re uncomfortable altering their traditional way of doing things. This is why gaining comprehensive user input early in the project and providing ongoing training are important to bringing users on board.

Key considerations include:

• Gain input from users during the planning and discovery phases. Ensuring users’ input during these key phases helps them to be part of the process and engages them in using the new software.
• Provide training on an ongoing basis. Ongoing training helps users feel comfortable with the new software and related processes, and increases their preparedness to use it.

Not getting the necessary support from senior leadership can also be a major barrier to success. When users see that top management is committed to supporting the project, they’ll have a higher level of acceptance for the project. For this reason, it is critical that company leaders articulate a compelling business case for implementation to all users, ensuring that everyone knows adoption is strongly supported at the executive level.

Best Practice #3: Assess Potential Risks

Certain risks related to software and people are inherently involved in a major implementation project, due to technological change, organizational change and project complexity. These significant risk factors – stemming from operational complexity, lack of user experience, lack of role clarity and a wide range of other issues – are the hallmarks of many major software implementations. This is why, before actual execution of the implementation project, it is vitally important to identify and classify all potential risks that could hinder the process, and then to take the necessary steps to mitigate or manage those risks.

Key considerations include:

• Identify and classify risks. List all potential risks that could hinder implementation, and classify the potential risks into categories such as schedule, budget, operational or technical risks.
• Identify risk-mitigation actions. List all actions necessary to avoid the potential risks listed. Be proactive by implementing the measures you listed as necessary for avoiding potential risks.

By identifying, classifying and managing all potential risks through analysis, the implementation team is more likely to help ensure that the entire project goes smoothly and successfully.

Best Practice #4: Provide Sufficient Resources

Many companies invest a lot of money into new software, only to fall short in allotting adequate budgetary and labor resources needed for successful implementation. While the solution provider will supply some key resources required for implementation, there are a number of other resources that must be provided internally to achieve success. Because company projects tend to compete with one another for attention and resources, a lack of resources and support for a given project is often tied to a failure of ensuring executive sponsorship.

Key considerations include:

• Conduct careful resource planning. Adequate resource planning includes building a team with the skills required to do the work and scheduling non-labor resources that will enable the team to complete the project.
• Emphasize executive sponsorship. While management signed off on purchasing the software solution, shifting priorities can divert attention and resources, resulting in the project losing powerful support.

It is difficult for project leaders to make sound, timely decisions if resources are hard to secure. They are much more likely to have a smooth implementation experience if the appropriate resources are allocated and assigned.

Best Practice #5: Establish Realistic Expectations

When developing the project, it’s important to establish a clear understanding of attainable goals and realistic expectations among everyone involved, from executive leadership to administrative users. For example, just as you shouldn’t underestimate the budgetary resources and workforce productivity required for a successful implementation plan, you shouldn’t underestimate the time needed to complete the project. Many organizations set overly optimistic go-live dates despite the realities and limitations of the actual project, but it’s crucial that project leaders balance go-live dates with other interdependencies such as available resources.

Key considerations include:

• Set realistic time frames. A schedule can turn out to be unrealistic when you underestimate the amount of consultation, validation and other services needed for a smooth implementation.
• Manage expectations. Setting realistic expectations upfront and keeping them top-of-mind among stakeholders helps maintain perspective of the whole project and the scope of each step.

It’s important to understand that even with an implementation schedule in place from the start of the process, unforeseen issues often arise, meaning that as the project changes or evolves, the process must evolve with it.

Best Practice #6: Monitor and Communicate Continuously

Monitoring and communication should be integrated into all stages of the implementation project – including after going live. The process of software implementation is dynamic, which is why it is important for project leaders to develop milestones, monitor and communicate progress continuously, promptly address issues that arise and maintain a good working relationship with the solution provider.

Key considerations include

• Conduct milestone audits. Auditing each milestone throughout the project helps ensure both the service provider and the internal implementation team are meeting their responsibilities.
• Communicate with the vendor. After go-live, maintain communication with the solution provider about ongoing maintenance services, including technical assistance and software updates.

Implementations occur over time, during which a company’s fortunes and priorities may change. Such changes may negatively affect resource availability, solution requirements, executive support and user adoption. This type of situation can set the implementation back, but it doesn’t have to derail it. If you encounter a shift in priorities, let your solution provider know and try to work with them to accommodate these challenges.