FDA-registered manufacturers in industries such as pharmaceuticals and nutraceuticals have several unique challenges, including:
All of these challenges amount to increasing pressure to maintain competitiveness and provide ROI for pharmaceutical companies, while simultaneously complying with an ever-widening array of regulatory requirements.
A successful Sage Enterprise Management (Sage X3) implementation can achieve a return on investment (ROI) in the shortest possible time. Return on investment does not simply refer to financial gain, either – you can also measure ROI in terms of growth in productivity and efficiency or in terms of overall improvement in the performance of the company or even to the extent of the satisfaction of the users.
Every organization has its own cultural structure, and it’s natural for an organization to be skeptical about an erp implementation – they might fear it will not be unique enough to fit their culture. Sage Enterprise Management, however, was designed with and is being continually upgraded to incorporate the best industry practices for most industry segments.
With thorough and dedicated business process mapping, elimination of non-value added steps, and adapting changes in the business process well before implementing Sage Enterprise Management, your implementation will run smoother. Without this methodology, there is a chance of wasted time, frustrated users, poor participation, costly delays, and more.
It is important to understand that an ERP package will not necessarily perfectly fit with your existing business practices, especially if you’ve been forced to adhere to certain practices due to existing software. This is your chance to create some “best of breed” business practices – you can the keep the processes you use now that work and adopt Sage Enterprise Management processes in place of those that don’t.
It’s also important not to expect a miracle. Your users’ workloads won’t get smaller the day after your new ERP goes live, for example – an ERP package is only an enabling tool that improves the flow of information and formalizes the business processes and workflows that exist in an organization. It will help your users be better at their jobs, but it’s not a cure-all.
Sage Enterprise Management is fine-tuned to meet the specific needs of FDA-registered manufacturers. By combining advanced manufacturing, distribution, warehousing, customer relationship management (CRM), and accounting functionality, Enterprise Management addresses the specific needs of:
Additionally, Sage Enterprise Management helps FDA-registered manufacturers comply with the government reporting required under the Bioterrorism Act and 21 CFR Part II by providing a convenient and efficient way to gather and monitor relevant process information without the time-consuming manual procedures.
Also, to minimize the risks of a product recall, Sage Enterprise Management provides complete forward and backward lot traceability in addition to a full audit trail and archive of historical transactions for multi-year periods. The fully integrated quality control process rigorously enforces inspections to required characteristics, operational tolerances, or expected results.
Sage Enterprise Management offers a web-based dashboard for its users, where they see a role-based menu system with information specific to their job, and graphical workflows drive business processes. Sage Enterprise Management also has a fully integrated CRM to turn leads into customers and to track opportunities.
The software can track internal or external development projects, which can be attached to quotes. You can use this to internally track sample requests as they’re processed and shipped to customers. In manufacturing, a test plan can be set up to perform in-process testing of a batch. When entering an order, you can check the inventory of the finished good and the components inventory when the manufacturing order is created. The system also offers a visual scheduling tool.
Southeast Computers Solutions is one of the largest and most skilled integration teams with life sciences capabilities and experience. We can help you implement Sage Enterprise Management and get the ROI your business needs to stay ahead of the competition. Contact us today for more information.