Biotechnology entails the study of living organisms and their practical applications to solve real-world challenges. The field has benefited society through innovations that address climate risk, food security, and infectious diseases—and enhance the quality of human life.
As the Covid-19 pandemic hit, the world turned to biotech and pharmaceutical companies to develop life-saving vaccines and drugs. Even before the pandemic, the industry was growing by leaps and bounds. Many exciting technologies used in new treatments, the Internet of Things (IoT), artificial intelligence, and advanced analytics are just a few advancements that have been nothing short of revolutionary.
However, each new innovation generates more complexities and prompts a slew of new regulations. ERP for pharma companies helps ensure compliance and quality control, as well as improves patient outcomes.
Many ERP solutions promote themselves as the best option for biotech and pharma ERP implementation. Despite these claims, some may end up becoming large, yet useless, capital expenses. To avoid costly mistakes, do some research and evaluate several ERP solutions on the market before choosing the solution that aligns with your operations.
Industry Fit
Serial batch tracking is vital in the pharmaceutical industry. Go for an ERP system that has robust functionality that addresses pharma-specific needs including batch traceability and serialization. This allows you to comply with industry regulations and implement any product recalls. Automated tools like barcode readers make the process more accurate and less tedious.
Formulations for drugs and therapies are complex. Raw materials sourced from a myriad of vendors may vary in availability and price, adding more complications to an already complex process. Determining the correct combination of materials and making sure the right production processes are in place is critical. Maintaining the purity and potency of each drug is extremely difficult without the aid of an ERP system to keep formulas consistent. Some of these ingredients are also perishable so expiration dates must be tracked appropriately.
Regulatory Compliance
Regulatory compliance for pharma companies is intense. The U.S. Food and Drug Administration mandates that all production records be documented electronically. Quality control requires clear documentary procedures and standard operating procedures (SOPs) to ensure that drugs adhere to high standards of identity, strength, quality, and purity. Any deviation from SOPs must be properly recorded along with clearly stated justifications.
These challenges can be managed correctly with an ERP system that offers a high level of transparency and streamlined workflows. An ERP helps maintain quality assurance through sample and batch management tools; it also allows seamless communication and collaboration between quality control units so that there is only a single version of the truth. With an ERP solution in place, the chance of costly paperwork mistakes and preventable recalls is minimized.
Total Cost of Ownership
Deciding to invest in ERP systems for biotech is a big decision. Aside from the upfront costs, there are other factors to consider. For example, implementing new technology may take employees away from their usual duties. If the software is not intuitive enough for nontechnical staff, experts may be needed to train end users. ERP solutions that are not tailor-made for life sciences may need additional customizations and software upgrades, and ongoing maintenance fees should also be considered.
Of course, for a reliable and reputable ERP system solution, NBS has you covered for any industry–including biotechnology and pharma. Contact us today to learn how we can help you with the best possible ERP implementation.
