The life sciences industry is facing many issues today that are both exciting and challenging. The industry is constantly evolving between preclinical and market phases. The right ERP system supports the continued evolvement of life science companies through quality control, cost management, FDA compliance and market integration. Let’s look at each of those key features and functions in a bit more detail.
When you’re in the life science industry, whether it’s human life or animal life, quality is job one. Quality and safety standards must be upheld, or it can lead to tragedy for your consumers and your company.
Traceability. Your cloud-based ERP allows you stay on top of regulations involving traceability, which can be ever-changing and ever-evolving on a global scale. We have never been more focused on worldwide health, and traceability can seem like a moving target.
Track product systems more easily. NetSuite’s ERP platform can give you a real-time view and up-to-the-minute data, allowing you a truly holistic view of where your business is at any point in time.
Minimize issues with clients or customers. Your ERP will automatically record every interaction in a single, searchable system, from phone calls and emails to sales transactions and even support tickets.
Real-time access to information. This can be life-changing for many growing businesses. NetSuite says you’ll know your business like never before, and we’ve seen that happen in practice time and time again. The insights you gain from real-time data can empower you and your employees, taking your business to a new level of efficiency.
Cost management is an essential part of any business. But for life sciences, which are evolving at a rapid rate, the financials need to be rock solid. The right ERP system will do that work for you, allowing you to spend more time focusing on other pieces of the puzzle.
Efficiently monitor spending. With NetSuite, you’ll see your financials on a single, true cloud platform.
Track daily, weekly, monthly expenses. With this ERP, you can streamline your reporting, getting faster end-of-the-month closes, and better understand vendor costs. Getting this kind of real-time handle on the financials will make you more efficient and profitable, allowing you a clearer view of exactly where you are.
You know that the FDA is the sentry standing between you and the U.S. market, and compliance with their regulations could not be more important. This is true whether you’re in the pre-product launch and testing phases of product development, if you’re ready to enter the marketplace or if you’re a seasoned veteran.
Good Manufacturing Practices (GMP). According to the FDA, the agency “ensures the quality of drug products by carefully monitoring drug manufacturers’ compliance with its Current Good Manufacturing regulations.” That means products need to contain the “minimum requirements for the methods, facilities and controls used in manufacturing, processing and packing.” In order for a product to be approved to enter the U.S. market, the FDA will conduct a review to make sure you’re in compliance with the GMPs. It can be a confusing process, but your ERP can help validate many systems for regulatory compliance.
21 CFR Part 11 compliance. 21 CFR Part 11 is a section in the Code of Federal Regulations that outlines the FDA’s guidelines for using electronic signatures and records for the medical industry. It’s about ensuring the validity, authenticity and confidentiality of these digital records to ensure the validity of clinical trial results. It’s the law, but as with all things related to government regulations, 21 CFR Part II can be mind-numbingly complicated. NetSuite has tools built into its toolkit to help with that. NetSuite doesn’t automatically make you compliant with 21 CFR Part II, but helps you to assess and maintain your compliance. In other words, NetSuite provides the tools you need to enable compliance, but ultimately, the responsibility is up to you. Read more about it in our blog “System Validation and Compliance: How GBS Can Help.”
The many phases involved in your product’s lifecycle are the reason the life science industry is so exciting and challenging. The right ERP system, customized for you, can support many processes and phases for products. The combination of Oracle’s powerful NetSuite and our finely honed customization are perfect to help growing businesses increase sales and manage expansion, innovation and growth.
At Green Business Systems, we are an official NetSuite ERP solutions and implementation provider. We help companies, including those in life sciences, make their businesses more efficient with the power of NetSuite. We use a methodology fine tuned over many implementations to deliver consistent results, customizing the software for your particular needs.
We start with defining business needs and management expectations, and build the system that’s right for your business now and in the future.
Contact Green Business Systems today to learn more about ERP software for life sciences.