By Jay Deakins
Successful pharmaceutical manufacturers are continually looking for ways to build efficiencies — trying to increase productivity and gain an edge in today’s highly competitive marketplace. Yet many companies continue to use multiple, nonintegrated software systems to manage their business processes. This can compromise data integrity, complicate lot tracking, and convolute system support, among other problems, actually creating inefficiencies.
Of course, no company intends to run its business inefficiently; it’s a problem that creeps up on you. When your business is first starting out, you might adopt a lab management program and accounting software. Using manual processes such as spreadsheets to fill in the gaps for purchasing, sales, inventory control, and other business processes, you get the ball rolling.
Then your business grows. You might add more software systems or spreadsheets to pick up the slack or customize the programs you have. But eventually, this method breaks down. What was once easy to track with pen and paper and some extra data entry or programming becomes unwieldy, time-consuming, and full of errors — putting your business at risk for recalls and noncompliance.
In order to ensure data integrity and conduct true lot tracking, it’s imperative to integrate all your business processes, including formulation and lab management, inventory control and lot tracking, production, sales, purchasing, regulatory reporting, and accounting in one software system that is specifically designed for your business. The advantages of adopting such a system are many. Here are the top four.
1. Single Point of Control
The primary advantage of using an integrated pharmaceutical software system is achieving a “single point of control” for all business data. When all data is stored in one and only one software program, it is the sole source of information for your company. This eliminates duplicate data entry. Customer, inventory, formulation, production history, and lot and batch control updates are processed once with real-time transactional posting.
Additionally, using a single system lets you view real-time information from any part of your operation from one software location. You log in to one system to view formula revisions, check on-hand inventory, update pricing, and generate financial statements and regulatory reports.
2. Data Integrity
When information is scattered among multiple, nonintegrated software systems, it’s difficult to maintain the information in each system and ensure each version is accurate. In fact, there’s a basic software axiom that no matter how hard you try, storing data in two places means that data will eventually be different. And when you discover conflicting data, you’ve got to spend extra time researching which version of “the truth” is the real truth and updating your records accordingly.
But with a single, integrated software system, information entered in one location will always be the same.
3. Lot Tracking, Traceability
When using multiple programs to handle purchasing, inventory, production, and sales processes, pharmaceutical manufacturers often turn to manual methods for tracing lot histories. Without a central location for all data, you would have to pull inventory listed on a batch ticket, write down the lot numbers, and then go through the manufacturing process. It can work, but it opens the door for a lengthy recall process in which you may not be able to account for 100 percent of the affected materials.
Using a single, integrated system allows you to track the path of a lot from item receipt through shipment in one, electronic system. Using bar code or RFID (radio frequency identification) technology, you can label lots upon receipt and then track them as they move through production and shipment, with the system recording all time and date stamps required by FDA regulations. In the event of a product problem, you can enter the lot number and view the lot’s complete and accurate history.
4. Detail Drilldown
Much like pulling a lot history, all research and reporting is improved with a single software system. Because all data is in one spot, you can manipulate search criteria in prefilter screens to view sales rankings or outstanding purchase orders, for example, by date, customer, or virtually any other criteria. This type of visibility can help you make better business decisions.
From summary reports, you can drill down to view specific transactional details. For example, from a lot tracking summary report you can view the details of the purchase order, production jobs, and customers who received shipments of that lot by clicking on the lot history’s line items.
5. Regulatory Document Generation
Creating accurate regulatory documents, such as certificates of analysis (COAs) or product labels, is streamlined using a single system. Instead of gathering data from a separate lab or customer relationship management (CRM) system before creating the documents in another, offline program, a single integrated system stores all the relevant data for a particular batch or shipment. Generating a document is as simple as selecting the product and customer. The data then populate the appropriate form(s), which can be configured differently for each product and customer.
6. Basic Training
Software training is less complicated when using a single integrated system. Users learn the “look and feel” of one system, and the business practices associated with it – as opposed to figuring out how to navigate several different system landscape designs and controls. This expedites the training process so your employees can become proficient with your system faster and with fewer headaches.
7. Minimal IT Maintenance
Of course, when you’re using only one system, your software support problems are fewer, in general. Rather than juggle the support of several systems, technical personnel handle regular updates and backup method for only one system. Network issues, such as software bridges and network infrastructure, are kept to a minimum.
8. Manageable Support
When you do have a problem or question, using one system means you don’t have to worry about keeping track of which vendor to call. This prevents the finger-pointing that occurs when vendors pass their software issues off to other software teams. Instead of wading through a number of sources, you have only one software support team to call when system questions or issues arise.
9. Easy Upgrades
The custom programs that are typically needed to pass data between two separate software systems require updates to the custom program if one of your vendors updates one system, so as to prevent system conflicts and data errors. With a single, unified system, you avoid this time-consuming process and the IT support necessary to manage updates for multiple systems.
10. Reduced Costs
The more software systems you use the more costs you generate. Utilizing several systems typically requires higher implementation costs, including adaptation to your IT environment, customization, user training, and integration with other corporate software, in addition to the cost of the system itself. On top of that, the increased possibility for errors when performing duplicate data entry, manual lot tracking or regulatory document generation can add to your cost of doing business.
One of the best ways to build efficiencies within a pharmaceutical manufacturing company is to integrate your business processes in a single software system that’s designed for your business. By acting as a single point of control, a fully integrated system can help you establish data integrity and true lot tracking perform detail drilldown, and generate regulatory documents. It also reduces costs, eases system training, and provides for minimal IT maintenance, manageable support, and easy upgrades. Overall, these benefits can help you manage your business processes simply and efficiently, positioning your company for success in today’s marketplace.
About The Author
Jay Deakins is president of Deacom, Inc. (www.deacom.net), a producer of integrated accounting and ERP software for mid-to-large-size manufacturers of pharmaceuticals.