By Ave Anderegg, Staff Writer, MasterControl
Here we are facing the undeniable research that any company hoping to keep pace with industry trends will have to go digital sooner rather than later.1 Was it Tolstoy who wrote, “All enterprise software implementations are unique”? I think he was actually talking about unhappy families, but never mind that. They are unique, however, there are six best practices that will improve the likelihood of any successful quality management software implementation project - something we can all be happier about.
1. Define Your Enterprise Software Solution Needs and Objectives
An enterprise solution is one that is designed to integrate operations and personnel across an entire organization. Surveying all stakeholders can help you clarify what you are looking for in a quality management system (QMS) solution. Why are you looking, who will be using the new solution, and who will be responsible for ensuring that everything runs smoothly?
Know your configuration and organizational requirements. List all processes intended for automation, current challenges associated with them, and personnel involved. Proceed to outline the benefits. Allow involved parties to coordinate your software implementation through targeted efforts. This will speed up both implementation and adoption.
An objective may be as broad as “Eliminate nonconformities,” or as specific as “Implement a corrective action/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.” Continue to refine objectives during implementation.
2. Get Your Team on Board With a QMS Software Solution
Investing in a powerful enterprise software solution can be extraordinarily valuable to your organization. It is important to make your case to decision-makers as well as end-users to get the necessary funding and resources for a successful software implementation. A recent Harvard Business Review study shows that 71% of business leaders rank collaboration as the most important characteristic of transformational culture.2
Emphasize executive sponsorship.
Be prepared to present your findings and recommendations that fall in line with the goals and objectives of your executive team. Use tools such as an ROI calculator, a data sheet, or a good old-fashioned brochure (paperless of course). Once executives make this investment a high-level priority and publish it widely, you'll have a higher level of acceptance for the enterprise software solution throughout your organization.3
Get user input.
Don't wait. Get input from end-users during the planning and discovery phases of your software implementation. Find out what key performance indicators are essential for their success.4 Point out what's currently lacking that your solution will provide. This early-adoption strategy helps end-users take ownership sooner and makes future training less overwhelming.
3. Assess Potential QMS Software Implementation Risks
As you are taking both technological and organizational complexity head-on with enterprise quality management software, you will need to evaluate potential risks. Examples include system integrations, lack of role clarity, gaps in workflows, implementation, and training delays, etc.
Identify and classify risks.
List all potential risks that could hinder implementation. Classify the risks into categories such as operational, technical, scheduling, or budget. Prioritize high-risk factors. List all actions necessary to avoid the potential risks. Outline risk-mitigation actions.
Dialogue with regulators.
Enter discussions early with regulators as you plan your project. Inspectors can offer key insights into how your solution can impact quality objectives and compliance. You can resolve many concerns and unknowns with regulators' help.5
4. Provide Sufficient Implementation Resources
Many companies invest a lot of money into new software, only to fall short in allotting other resources. The solution provider should supply some key resources required for software implementation, but others must be provided internally. Remember, projects compete for resources.
Build a team.
Your team needs to be cross-functional. Include members that will be impacted directly. Look for diverse skill sets needed to do the work, such as IT personnel or trainers. Executive leadership is essential to keep the project moving forward.
It is difficult for project leaders to make sound, timely decisions if resources are hard to secure. Take into consideration both human and financial capital. Plan scope and logistics to maximize value. For example, set up group training or reduce travel.6
5. Establish Realistic Expectations
When developing the project, establish a clear and shared understanding of attainable goals. Strike an honest balance between benefits and barriers. Outline the changes coming your way. Disclose how the enterprise software solution will impact your organization and when.
Set realistic timelines.
It's crucial to balance go-live dates with other interdependencies, such as budgetary resources and workforce productivity. Don't underestimate the time needed for consultation, validation, and training. Break down the project into milestones and track them.
Even with a software implementation schedule in place from the beginning, unforeseen issues often arise. When variables take effect, the project may need to evolve. Adjust expectations and scope when necessary. Strive to keep them aligned with needs and objectives.
6. Monitor Enterprise QMS Implementation Progress and Communicate Continuously
The process of quality management software implementation is dynamic and occurs over time. It's important to monitor and communicate progress at all stages. Maintain good working relationships with the solution provider and your team to promptly address issues.
Conduct milestone audits.
Auditing each milestone throughout the project helps ensure both the service provider and the internal software implementation team are meeting their objectives and fulfilling responsibilities. If they're not, you can catch these problems early and creatively work together to get back on track.
Communicate with the vendor.
Work together to overcome any obstacles. After go-live, maintain communication with the enterprise software solution provider about fulfillment, ongoing maintenance services, technical assistance, and updates.
Your organization may experience setbacks and priorities may change. This doesn't have to derail your enterprise software implementation project. By returning to these proven practices, you'll get there, and it will all be worth it.
- "Rethinking Digital Transformation", Harvard Business Review, Mar. 31, 2020.
- Supra note 1.
- "5 Tips for Getting Executive Backing for a New or Expanded EQMS", MasterControl, 2019.
- Supra note 1.
- "Smart quality: Reimagining the way quality works", by Alvaro Carpintero, Tacy Foster, Evgeniya Makarova, and Vanya Telpis, McKinsey & Company Insights on Life Sciences, Jan. 25, 2021.
- "Developing a Quality System on a Managed Budget", Keith Matthews, GxP Lifeline, Jul 11, 2017.
Ave Anderegg is a professional mom of six and content writer for MasterControl. She brings a technical perspective, focused on the usability and accessibility of working solutions. Previously she worked as a technical writer and documentation manager for software development companies that support community infrastructure. She holds a bachelor's degree in comparative literature from Brigham Young University.