The Life Sciences industry (Bio-Pharma, Medical Devices, Biotech, etc.) is unique in many ways beyond the products they bring to market, especially how organizations “evolve” as they go through the dynamic stages of company growth - from start-up (pre-revenue and trial) to the commercial market with revenue generation.
Each of the stages of this life cycle has its own unique requirements, but even across the diverse product landscape it usually comes back to 5 key requirements that companies need to address with their overall business management and ERP (Enterprise Resource Planning) systems. While some of these areas are not necessarily handled directly in their internally (for example, many companies outsource manufacturing), they are still vital processes that need to be supported, enabling access to the right information in real-time to make informed decisions based on accurate real-time data.
When the FDA or other Regulatory Agencies are in charge of the market in which you are launching your Life Sciences product, patient and customer safety extends far beyond simple company guidelines. They are going to set the standards (which they will change over time) for thresholds, and processes that include: validation of security, manufacturing, quality controls, audit trails, and overall information/data policies and practices.
It may happen, and you hope it never does, that your product has a quality issue or has some adverse effect, and you need to track each component back to its source. With that risk on your company, you need have to have the processes and data in place to ensure you are able to minimize the impact on the patients, customers, and your business. As with all industries, it just makes good business sense to understand the quality and supply-chain involved with your products throughout their life-cycle in order to make improvements to future products and processes.
Real-time access to information
In the Life Sciences Industry, change is exceedingly rapid and the demand for financial visibility to control cash flow is crucial. Therefore, you need an ERP system that can give you the right information at the right time through built-in powerful reporting and analytic tools. Spending time chasing down reports and exporting/importing spreadsheets from underpowered or single-point solutions, are time and money wasted.
Developing a viable Life Sciences product takes not only talent but enough time and money. Access to this level of funding isn’t nearly as easy as it once was, and a substantial amount of funding is needed to support these ongoing R&D efforts to bring to market the next big drug or device. Therefore, you need a system that goes well beyond an accounting application, a complete solution that can monitor your sending to vendors, operations, and financial institutions all while allowing Investor and Manager 360-degree visibility into day-to-day expenses.
When that oft anticipated day comes that your new drug or device is given approval, your business will pivot from pre-revenue to hyper demand creating a ramp-up sales, production, and fulfillment, not to mention the change in accounting practices. This all needs to happen yesterday and you need a system that scales with the growth to support the many processes that come with a commercial product going to market; including manufacturing (or integration to an outside manufacturer), 3PL integration, sales and marketing, production planning, quality management, complex supply-chain, multinational and multi-location reporting.
Navigator with our proven approach provides Life Science companies the experienced leadership to leverage cloud solutions to support growth and change, while reliably controlling back-office costs, monitoring compliance with FDA: 21 CFR Part 11, and improving operating margins. Navigator has a proven track record of on-time, and fixed-price implementations – all of which have enabled Navigator to serve as an SAP Gold Partner for the last 10 years.
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