The life science industry has to meet strict regulatory requirements in an extremely competitive environment burdened with financial pressures and unique market demands. Companies in this field can spend years in product development, conceptualizing, and running preliminary clinical trials before they can get approval from the FDA to manufacture and sell a product to consumers. After the company emerges from the initial R&D phase, it needs to transition smoothly into the process of testing and commercialization.
Companies face a number of challenges in implementing product development, manufacturing, supply chain management, risk management, and quality control while ensuring compliance with industry regulations. A robust Enterprise Resource Planning (ERP) system can streamline workflows and optimize business processes. By embracing cloud-based ERP, you gain a cost-effective, flexible, and scalable means to enhance business efficiency and effectiveness with security and reliability.
Integrated data with intelligence and compliance
One of the hurdles in life science is integrating data from siloed systems to provide real-time analytics. Life sciences companies may receive sudden notice that commercial production can begin, making it crucial to consolidate all this information in a short time. An ERP system will assist with the data integration necessary for commercialization.
The FDA has set certain regulations known as GMP (Good Manufacturing Practices) that serve as general guidelines for product manufacturing at life science companies. Life science products need to be of the highest quality due to the impact they have on public health. ERP platforms align with FDA regulations to help life science companies ensure compliance. This helps streamline resource gathering, product manufacturing, and quality assurance.
The Digital Core of Your Business
One of the leaders in cloud-based ERP –SAP Business ByDesign—is the digital core of many businesses. It provides pre-built end-to-end process scenarios. The solution supports multiple companies, countries, and currencies right out of the box.
It manages complex supply chains in which manufacturing takes place in one country and the final assembly of components takes place in others. It can identify stock from a track-and-trace perspective. And it supports GMP for both discrete and process manufacturing.
SAP offers a number of comparative advantages, which we’ll explore in the next sections.
SAP Best Practices for Specific Industries
SAP’s functionality encapsulates best practices that have evolved over the years. These provide a baseline configuration, standard business processes, and a library of detailed documentation. The goal is faster and more successful implementation.
The individual, activatable units of best practices are called scope items. There are over 200 scope items built into SAP, representing different business processes or functions from various industries. Each scope item can be activated in a sandbox and has a process diagram, a detailed test script, and configuration documentation. You can access the scope items from a library of best practices to suit business requirements specific to a number of industries—including life sciences.
Embedded Quality Control and the Work Center
For life science, SAP Business ByDesign delivered by Navigator Business Solutions has embedded quality control. This includes embedded warranty tracking for medical devices, and service management capabilities as well as a validated platform. It comes with prepackaged SOPs, and enables businesses to only register the tenant itself in terms of compliance.
The ERP platform allows a high degree of FDA monitoring, with complete track and trace via lot batch and serial number, user authorization, and login control management. Every transaction is marked with a date, time, and the user that created it.
There's a change log maintained for every update to a document or master file record. SAP ByDesign has strong bill of materials revision control and variance support, along with integration with network track and trace solutions. And those prepackaged SOPs help facilitate the validation process.
The launchpad in the ERP solution offers personalization: a user can adapt, add buttons, add tiles, and add analytics to create the most productive environment while getting access to different work centers unique for SAP. These can accommodate everything that users want, including the inbound and outbound supply chain, quality, project management, payroll, all financials, receivables, payables, liquidity and payment management, and a general ledger—all scoped and configured for each user by using a set of checkboxes as part of the business configuration.
Unique Advantages of Navigator
Navigator is an SAP partner as a distributor of their cloud-based ERP solutions. We specialize in the life sciences and have a number of success stories in viral vector manufacturing, gene and CAR T cell therapy, cell banking, sterile fill, pharmaceutical manufacturing, and medical device distribution.
One reason life sciences firms choose us is because we use a preconfigured package based on SAP Business ByDesign, which enables companies to grow from pre-revenue to and through GMP and full commercialization and validation.
Navigator has built its own specialized modules for SAP Business ByDesign, including e-signature PIN requirements and the ability to create a CAPA case directly from an inspection. Our industry experience has helped us understand where the gaps were in ByDesign’s quality features, and that informed the development of our own advanced quality module. Learn more about how Navigator can help life sciences companies reach their full potential.