In this piece, Irene Birbeck breaks down some of the common frustrations our clients see when they aren’t getting the most out of their quality systems investments and how MVP3: Minimum Viable Product, Project, and Players can serve as a guiding principle. 

Recently, I’ve been working with a few clients to evaluate existing implementations of one of their quality systems. They all start the same, with a phone call or email letting me know that they put in a system a few months (sometimes years) ago, and it’s just not working for them the way they think it should. Sometimes, the person on the other end of the line is from IT, and they can’t understand why the business hasn’t adopted the system. Sometimes, they’re frustrated that they aren’t getting the value from the system they hoped, which could be costing them hundreds of thousands of dollars a year. Other times, the call is from the business, whether that be a member of the laboratory, CMC, research, or quality team. They are frustrated by the system’s usability, or they say they can’t get important data out of the system.  

These frustrations are valid – a well-implemented quality system should function properly, have competent end-users who have adopted the system, allow for data querying and reporting, and comply with data integrity standards where necessary. When clients reach out, their projects haven’t had that outcome, though, and this is where I’ve noticed a few common things have usually broken down: 

Common Frustrations with Quality Systems Investments

1. The Going Got Tough 

Systems can be hard for end-users to accept. A business could invest all its money in organizational readiness, and there would still be a learning curve. And there will always be dissenters. We call this period of turbulence the “valley of despair” and try to prepare our clients for it. There are activities that minimize the valley’s depth and the length of time users are in it. Without this preparation, I’ve talked to clients who have abandoned their systems when the going got tough and got little to no value from the time, money, and energy they invested in a system. 

2. A Day in Who’s Life? 

Out-of-the-box systems may not automatically align with the way scientists, quality personnel, or customer service representatives perform their work. Sometimes the system doesn’t match the existing business process. Sometimes performance issues are discovered after go-live that impact usability. For example, attachments from certain instruments can be too large or PDFs can be unsearchable. Projects should contain activities that assure “a day in the life” of the users is both possible and practical. 

3. Business Requirements Were Missed 

Probably the most frequent and obvious complaint is that business requirements were just missed. These can be little or big requirements, causing pain or making the system unusable all together. What I’ve found most fascinating lately is that the common root cause seems to be some variation of this phrase: “We tried an out-of-the-box minimum viable product (MVP) implementation.” 

Getting the Most our of Your Quality Systems Investments

While I continue to be impressed with the out of-the-box solutions in the quality systems space, and Clarkston encourages an MVP approach to implementation, it’s clear there is nuance here that is tripping up our clients on many of their projects. Businesses are making investments and then not getting the value they expect from their quality systems projects. Products can feel hard to use, and businesses may believe the solution just isn’t living up to its promise. 

Quality systems implementations can be different! We still believe in the MVP. IT and the business counterparts alike should push for the MVP especially when they are budget conscious, on a timeline, and have human capital constraints (which is every single one of our clients), But, let’s think of it multi-dimensionally. I’d like to introduce the MVP3 – Minimum Viable Product, Project, and Players.   

MVP3: Minimum Viable Product, Project, and Players

Minimum Viable Product 

We believe in and advise our clients to implement the minimum viable product and then iteratively improve from there. Our clients find that this is the best way to get value from their investments. In addition, as they learn more about the technology and how their business interacts with it, they make smarter enhancements in a more efficient manner, keeping the total cost of ownership down. It’s important to identify both business and industry requirements and then align a system roadmap to achieve MVP.  

This all sounds good in theory, but it gets tricky in practice. Very often, a minimum viable product must be accepted by users that expect more than “minimum” from their systems. Frequently, a new ELN, LIMS, or document management system is not replacing a minimum viable solution. It’s more likely replacing customized spreadsheets or a paper-based process that allow all manner of processes and exceptions. Because of this, implementing a system can be a loss of functionality, take away freedom, or even make someone’s job less efficient. While end users may not love their existing system or process, they may insist it’s better than a new MVP and refuse to adopt it. These are real challenges, and they must be identified up front and addressed through organizational alignment, change management, and possibly changes to the MVP and its roadmap. 

Minimum Viable Project 

The minimum viable product is only as good as its implementation. Aside from standing up the system, validating it, and writing procedures, an implementation project can also involve varying levels of project management, business process alignment, and end-user adoption activities. In our experience, minimum amounts of each of these create a viable project, and what composes viability is company-dependent.  

Do you have the type of organization where research scientists have enough time to learn a new system on their own? Will they all work together to ensure they document their experiments in the same manner so that data supports patent filings and regulatory submissions or so that your company is protected from the data loss associated with attrition? If not, process design and training may need to be a project activity. Does your quality team have the bandwidth to assure that all the security profiles, procedures, and work instructions would support an audit? If not, you may need some external project management and business analysis from an external team. 

Minimum Viable Players 

The product and project must be supported by the right people on the project at the right time. If you don’t have the right expertise, your system won’t reflect your true business requirements. You must have the minimum viable players available and participating. Without this, exception processes may be missed and come up late in the project. This extends timelines or they get missed all together and decrease usability and adoption.  

We understand that getting time from the right people can be a real challenge when you need your best people running your business. The trick is to involve the experts in a targeted manner and efficiently – with gathering business requirements, vetting design, aligning the business to out-of-the box functionality, elements of user acceptance testing, and issue resolution. Also, it’s important to have them working with an experienced system integrator with industry expertise that will use their time wisely. Then, other tasks can be completed by your system vendor, system integrator, or a member of your business who isn’t as deep a subject matter expert and has more bandwidth for project activities.  

Clarkston Can Help 

If you’re reading this, you’re probably in one of two circumstances: you’re trying to avoid these mistakes or you’ve already made them. Clarkston can help with both. If you’re frustrated with an existing implementation, we can complete an evaluation and help map out the enhancements to get the most out of your existing quality systems investments. We can even align these enhancement roadmaps to your specific business milestones. For example, making sure that certain processes are ready to support commercialization, scale-up, customer audits, and more. And, we’ll consider the MVP3.  

Connect with our team today so we can help you run your next project from the start with the MVP3 as your guiding principle.