There are several ERP systems on the market designed to address the specific challenges facing pharmaceutical manufacturers. When you're a pharmaceutical manufacturer, however, it doesn’t always feel that way – it feels like you'll never find the solution that's right for your business.
Luckily, that's not true. Whether you need to optimize efficiency, manage compliance, or meet regulatory standards, there is software to address your needs. In fact, there are fully integrated ERP solutions for pharmaceutical manufacturers that manage everything from accounting to customer relationship management to manufacturing to sales and beyond.
Such systems give users a menu system that provides information specific to the user's job, and graphical workflows drive business processes. There is also a Google-like search capability to find information throughout the system. Sage Enterprise Management (Sage X3) is integrated with Business Objects and comes with five predefined cubes of data and thousands of metrics that don’t require additional consulting dollars to configure when using the “out of the box” metrics.
Sage Enterprise Management can handle your entire product lifecycle, from conception through approval through manufacturing. If you’re not in a position to implement a fully comprehensive solution, you still have options to fill the gaps. There are many add-on products designed to extend the functionality of existing systems to handle specific tasks like R&D management, compliance tracking, or quality control.
What issues most affect a pharmaceutical manufacturing company? What are the typical modules and features found in pharmaceutical manufacturing systems?
To answer those key questions, let’s take a look at some of the pharmaceutical ERP requirements.
Managing the production activities of your company is one of the most crucial steps in achieving product traceability. Functionality within production planning will allow you to track where each batch is within the manufacturing process. You will be able to set project completion dates and adjust them accurately based on your observations of the progress of each batch. Your product formulas will track raw materials as well as the products those raw materials create. The tracking of raw material lot numbers on the formula provides visibility into which raw materials were used in each finished product batch. This kind of material transparency is especially vital for quality control efforts and recall purposes. You can track when a batch was completed, which will in turn allow you to manage shelf life and expiration tracking.
The production of any pharmaceutical begins with formula creation, and tracking these formulas is vital. Also, with the need to constantly improve your products, you’ll require the ability to revise these formulas; a formula tracking system offers both functionalities. A formula tracking system will also give you the ability to scale batches and formulas so you can produce larger quantities in a single manufacturing run. Maybe you have formulas that involve ingredients that were created from other formulas. If so, there are many systems that track the lot number of each ingredient as well as lot numbers for ingredients used to make ingredients.
You likely have several steps of quality control testing in your manufacturing process. A module specifically designed to manage quality control activities will give you all the tools you need to ensure you’re delivering the same quality product each time. You can request quality control tests, track test results, and take corrective actions. Workflow management functionalities provide checkpoint tracking in your manufacturing process to identify when samples should be taken for quality control tests.
The compliance management functionalities available within pharmaceutical ERP packages are designed specifically to help you meet the requirements set forth by regulatory agencies. The ability to assign tasks to particular individual staff members is an important aspect of creating accountability in managing for compliance. The beauty of using a pharmaceutical management package is that the developer built the system with your business in mind. A good example of this can be found in the built-in forms and predefined workflows for compliance management offered in many pharmaceutical manufacturing ERP-oriented systems.
Manufacturing delays are costly, as they result in lost sales, dissatisfied customers, and wastage due to expiring products. With the MRP functionality available within many pharmaceutical systems, you will be able to set a production schedule in advance. MRP & production scheduling will take into account capacities (both machine and human), lead times on ingredients, predicted demand, and several other factors to ensure that you have the products available to your customers when they want them. At the same time, production scheduling will reduce inventory costs by ensuring ingredients and products aren’t sitting on your shelves for extended periods of time.
Strong purchasing controls are especially important for pharmaceutical manufacturers. A purchasing module allows you to track product vendors, set up vendor cross-referencing for products, and track lead times and vendor pricing variations. One particularly important bit of purchasing functionality in pharmaceutical ERP systems is the ability to track the lot number of each ingredient received from a vendor. Vendor material traceability can help to mitigate costs associated with recalls.
One of the aspects that makes inventory management in pharmaceutical manufacturing unique is the issue of controlling for material and product expiration. Often, FIFO- or LIFO-based inventory picking systems are inadequate. Systems designed specifically for pharmaceutical manufacturers allow you to set up inventory picking using a FEFO (first expiring, first out) process. The FEFO approach minimizes the number of products or materials that expire before sale. Integration with technologies such as RFID and barcode can further optimize the efficiency of your inventory control department.
A strong software system will handle everything from customer acquisition to post-sale follow-up and repeat ordering. As a pharmaceutical manufacturer, you have needs in addition to the basic customer management needs of any company. For instance, if you have a customer that is requesting the same item for the same application, they may require that the product come from the same lot as the previous order. Requests of this variety can be tricky to accommodate; empowering sales personnel with integrated CRM modules that provide strong visibility into order histories is extremely beneficial.
Back-office accounting functionality integrated with your pharmaceutical manufacturing package will encompass features like accounts payable processing, receivables management, financial reporting, and budgeting. If you’re running R&D projects, you’ll be able to track project costs through cost accounting features.
Reporting is key. Why bother gathering data if you don't have the ability to produce actionable information from that data? Some examples of pharmaceutical-specific reports include reports related to the frequency of expiring products in inventory, quality control test results, and trial. With many packages, you’ll also be given the option of creating custom reports or managerial dashboards.
Sage Enterprise Management has its own completely integrated CRM tool. You can convert leads or prospects to customers and use Projects to track opportunities. With the addition of workflow, the status of the project is tied to a person in the company. When entering an order, you can check the inventory of the finished good and the components inventory when the manufacturing order is created. The software can track internal or external development projects and can be attached to quotes. This means you can internally track sample requests as they're processed and shipped to customers. Also, Enterprise Management works with Formulator, which offers full-featured lab formula management. In manufacturing, a test plan can be set up to perform in-process testing of a batch. The system offers a visual finite scheduling tool that can be used manually, or you can choose to let the system put together the best schedule.
Sage Enterprise Management is a very viable choice for a mid-market pharmaceutical manufacturing company. Its many features allow you to meet federal and local governmental regulatory demands with ease. Contact Southeast Computer Solutions for more information.