With resources, capital and compliance on the line, how can you effectively manage risk during ERP deployment?
When you’re a small or midsize business in an FDA-regulated industry, implementing a new software can introduce a significant amount of risk. You’re dedicating a substantial portion of your annual budget to a system that will transform how you do business. This transformation is where the return on your investment lies, but to make it happen, you’ll need to manage your time, your resources and your budget – all while maintaining your compliance obligations. What could go wrong? Here are three scenarios to look out for during your ERP implementation – and how to get ahead of them.
1. Your system is not truly validated.
Manufacturers who work in FDA-regulated industries know that 
regulatory compliance is dependent upon successful business process validation – including the functions managed by your ERP system. The process of validating a new ERP system can consume valuable resources and material costs, and expose a company to the risk of FDA audit non-compliance if not correctly executed. “Pre-validated” ERP software packages can be an attractive option, but beware that out-of-the-box solutions don’t always deliver on their promise. There is no true one-size-fits-all answer, but vendor-supplied validation scripts and best practice templates can help reduce the effort, resources, and risk it takes to meet stringent regulatory requirements. To cover your bases, select a software partner who offers not only the tools but also the expertise to advise you as you complete the validation activities required for your company’s unique use case.
2. Your company isn’t ready for deployment.
It’s a common mistake to think of ERP implementation as an operation of IT when, in actuality, its effects will be felt throughout your entire organization. Agreeing to a rigid deployment methodology and unrealistic timeline can spell disaster down the road. Rather than automatically agreeing to a first-draft deployment calendar, think hard about potential sources of delay or difficulty and work with your software partner to plan accordingly. Have you adequately accounted for the time it will take to train your workforce? Maybe certain departments will need to drastically rethink their SOPs in light of the rollout, or you foresee possible supply chain complications that will need to be worked out. Factor in the time you need to introduce the system properly so you can maintain productivity – and compliance – before, during and after deployment.
3. You blow your budget.
As an early-stage life sciences company, the decision to invest in an ERP system is not one made lightly. The efficiencies achieved through your new software will be a boon to your business, but until those benefits can be realized, the focus will be on the price tag. To stay on budget, you need to expect the unexpected – and then account for it. Work with an implementation partner who will conduct a complete gap analysis and plot out exactly what’s needed to get you from where you are to where you want to be. Then, ask yourself about other scenarios or services that are not covered in your vendor’s proposal. For example, will you need temporary staff to help manage deployment tasks or your day-to-day work throughout implementation? What if another module needs to be added prior to your go-live date? Remember your total budget is something determined by you, not your software partner. Your leadership team and/or investors will be most focused on the total not the line items, so factor in a cushion where you can. Whether you need it or not, you’ll be glad you did.
