Comprehensive Industry Compliance Capabilities
Whether you’re subject to FDA regulations, or even DEA oversight, regulatory adherence should always be top of mind when choosing enterprise resource management solutions in the biotech industry. And, it’s one of the first things you ought to discuss with your ERP vendor of choice.
When you’re ready to discuss your pharmaceuticals ERP needs, come prepared for the conversation. In addition to preparing all the pharma regulations you’re observing, list all the ways in which you will need the pharmaceutical manufacturing ERP to help you ensure accurate compliance records. The ERP software should include workflows and controls that ensure compliance is observed at every step of the process.
Traceability and Accountability Across Your Supply Chain
At any point in time, you may be faced with the need to trace a product backwards to identify the source of a problem. In that case, a properly implemented pharma ERP can mean the difference between a disaster and a mere inconvenience.
In a nutshell, you need an ERP system report that can facilitate full transparency throughout the supply chain. That means everything from serialization, through traceability, and onto government reporting ought to be built into the ERP system.
Some basic functions to look for in ERP software, even for smaller pharma companies, are:
- Serial number tracking and tracing
- Lot controls
- Verification and transaction history
- Reporting capabilities
Proper traceability can be extremely difficult and time-consuming or it can just be another part of your business management processes if you implement the right ERP.
Recipe Management and Control for Pharmaceuticals
Strict adherence to manufacturing protocols is the foundation of your success as a pharmaceutical manufacturer. And that adherence starts and ends with adequate pharmaceutical ERP systems.
Your enterprise resource planning systems should be able to document every detail of your pharmaceutical manufacturing process, along with any values that are relevant to your final product. And not only that, but it should also account for how and where ingredients are stored, who has access to them, expiration dates, inventory in stock, and any other relevant information.
Before you begin comparing enterprise resource planning options, create a fully detailed description of your manufacturing processes and seek out ERP for pharmaceutical companies that comes the closest to being able to account for every step in that process.
If an ERP comes close to your needs but fails in a few key areas, speak with vendors about the potential of creating custom ERP solutions for large pharma companies. Often, you’ll find that the right ERP software is more flexible than may appear at first glance and can accommodate a wide range of needs for pharma companies with a little customization.
Last, but certainly not least, is quality assurance. It’s ultimately the most important part of the manufacturing process in the life science industry. Even major pharma manufacturers have been brought low in the past from small oversights in quality assurance.
Pharmaceutical manufacturing software helps make sure that materials, products, and procedures are visible to all, monitored, and applied properly. With ERP software like SAP systems, you can create automated audits for incoming raw materials to ensure that they meet industry standards of quality.
Top pharma ERP solutions can also align performance indicators across an entire supply chain, which also makes data much more transparent. This data helps identify any issues and improves efficiency among all participants in the process.
Your QA requirements are a deal-breaker when it comes to choosing the right ERP software. If an ERP solution can’t provide the quality controls your business needs, it’s going to cause problems down the road.
Additional Features of Top-tier Pharma ERP Solutions
We covered the must-have features of an ERP system for BioPharma companies above. In addition, here are some nice-to-have features in a life science manufacturing ERP that can be extremely useful on a case-by-case basis for companies:
- CAPA Management and control: If you’re taking steps to implement corrective and preventive actions methodology in your organization, the right ERP software will help you get it right. And ERP with the capacity to provide continuous process monitoring allows you to immediately spot instances of non-conforming processes.
- Medical rep management: If the scope of your business includes work with medical representatives, your ERP software can be an important part of keeping accurate and updated records of doctors, pharmacists, and other data entities involved in the process. Also, you can select an ERP that produces detailed reports about the amounts and destinations of any units ordered and fulfilled to medical personnel.
- Employee monitoring: In some cases, you may need your ERP to manage employee access to certain processes and steps in order to adhere to pharma regulatory requirements. If that’s the case, look for this feature within the HR capabilities of the ERPs you’re considering.