Deciding which accounting or ERP system will be the best fit for your business is a complicated decision no matter what industry you work in. But because ½ dozen or more government agencies govern the parmaceutical industry, your decision takes on another level of complexity. Because pharma companies must produce a consistent quality product while maintaining tight security, the success of your business relies on you making the right ERP buying decision. Without it, you can never comply with all applicable laws or sustain the level of efficiency needed to turn a profit in an industry where competition is fierce, and margins are often razor thin.
So, how do companies like yours choose the right pharmaceutical manufacturing ERP? As with any ERP buying process, the first thing you should do is consider your company’s unique needs.
For those who manufacture pharmaceutical products, this often includes things like:
- Stringent quality controls
- The ability to track ingredients all the way through the manufacturing process from raw material to finished product.
- Visibility into the financial performance of every aspect of the business
- Inventory tracking to ensure efficient order fulfillment and on-time delivery
- Strict security controls needed to comply with various government regulations
Keep in mind, the more complete needs list you can build before you research your pharma ERP software, the better off you will be. Taking your time with this first step makes it easier to weed out the pharmaceutical ERP’s that will not be a good fit for your business. So, we recommend getting as much cross departmental input as possible. It is important to include at least one person from each department that will use the software in the selection process.
Because each of these people perform different roles within your company, they will probably each have a different take on what the company needs from its pharma ERP software., So their input is critical to building a comprehensive list. Once you have your finished list in hand, you are ready to research pharmaceutical manufacturing systems.
With that said, no matter what your specific needs are, there are five things we have found almost every pharmaceutical company we’ve worked with needs in their accounting or ERP system. Make sure you don’t leave any of these off your ERP must have a list.
Five Features Every Pharmaceutical Company Should Look for When Buying an ERP
Recipe Management with Control, Security and Tracking
As a pharma manufacturer, your success begins and ends with your recipes and your ability to keep them safe. So, your ERP should help you protect your most valuable assets. Look for ERPs that allows you to document all the details associated with each ingredient and how it’s used in the manufacturing process. This might include things like:
- Particle size
- pH values
- How and where to store each ingriedient
- Purchase date
Besides tracking ingredient details, a good pharma ERP software will allow you to not only store your recipes but also save each revision with details on how, when and by who changed it.
Almost any ERP will offer basic inventory management features. However, one important consideration for pharmaceutical companies is making sure the ERP you select supports the first expiring, first out (FEFO) approach to inventory management. That way, you can make sure you maintain consistent quality and don’t risk harming any of your users by selling an outdated product.
Manufacturing Process Transparency and Traceability
To maintain peak efficiency, any manufacturer needs to keep a close eye on every part of their process. Never is this truer than in the pharmaceutical industry. In case anything ever goes wrong with one of your products, you need to know exactly what happened when in your manufacturing plant. So, your ERP system must allow you to trace ingredients all the way through the supply chain, from procurement to final sale.
Regulatory Compliance and Control
To comply with title 21 CFR part 11, a critical FDA regulation governing the pharmaceutical industry, it is crucial that whatever ERP you choose has features in place to help you ensure that records, electronic signatures and handwritten signatures are each accounted for and can be followed throughout the manufacturing process. While an ERP alone isn’t enough to comply with this regulation, many of them include features like workflows, approval controls and audit trails to help make compliance easier.
Depending on the products you produce, the DEA or EPA may closely watch your company. If that is the case, you will want to be sure the software you purchase can help keep track of your controlled substance or hazardous materials inventory, again following it all the way through the supply chain and creating a pre-manufacture notice before your company creates any new compounds.
Since safety is of paramount importance in this industry, any good pharma ERP software will include quality assurance capabilities. Look for a system that supports QA testing, documents the entire process and the outcome of each test. If the ERP can randomly identify samples for testing and compare those against your stated norms, this will speed testing and help ensure its validity.
We hope you found this information helpful and will use it to work with your team to develop your company’s specific list of features you need in a Pharma ERP solution.
When you’re ready to research your options, please visit this webpage. Here we have compiled a variety of ERP research and buying advice with a high-level overview of some of the most popular pharma ERP packages.
Not sure which option is the best choice for your business? No problem. Over our companies more than 25-year history, we have worked with pharmaceutical businesses of all shapes and sizes. Let us help you match you with the right technology to help you succeed in this highly competitive industry.