The Internet of Things can best be described as a group of network-enabled technologies which allow devices such as mobile phones, wearables and computers to…
The Life Science industry includes organizations in the fields of biotechnology, pharmaceuticals, medical devices, biomedical technologies and in general, organizations and institutions that devote the…
Life sciences companies are facing increased competition and experience periods of fast growth, especially after receiving FDA approval for a new product. As if that’s not challenging enough, there is increasing regulatory oversight which can be a distraction from core business processes. Early-stage and in-market life sciences organizations need more than entry-level software, but don’t need to invest heavily in costly ERP systems. Deploy a management solution that is flexible, agile and can support unique business operations today and well into the future.
Pharmaceutical, biotech, medical device manufacturers and other organizations in the life sciences industry provide life-changing products and value to customers. High quality products are expected and there is little room for mistakes, especially when a mistake can impact patient safety or health. Traceability requires close attention to detail and speed when a recall must be initiated. A digital business management solution will strengthen inventory management and the supply chain, as well as expedite the identification of each component with a quality issue.
As indicated in “Life Sciences: 6 Ways to Thrive in a Digital Future,” an eBook, minutes matter when it comes to saving lives. For life sciences organizations, managing quality issues for every component and every device is crucial, no matter whether they are located in house or at a customer site. Strong traceability requires close collaboration with supply chain partners and the ability to capture detailed product history documentation for each product. This level of data management simply can’t be trusted to spreadsheets or specialty software. Life sciences organizations need a unified, digital management platform, like MAXLife.
After years of securing investors, performing product design and testing, and submitting documents to the FDA, many life sciences organizations suddenly find themselves in a period of fast growth after receiving FDA approval. Product approvals force pharmaceutical, biotech and medical device manufacturers into the next phase, which is manufacturing high quality products quickly, efficiently and profitably. Life sciences organizations can manage the entire process, from start to finish, by replacing inefficient business systems with a more modern management solution.
Change can happen, literally overnight, at many life sciences organizations. After receiving FDA approval, you need to jump into action setting up manufacturing operations to get your innovative new product into the marketplace as soon as possible. As discussed in “Life Sciences: 6 Ways to Thrive in a Digital Future,” an eBook, being prepared for strong, fast growth after approval is no small task. Replace entry-level or niche systems with a business management solution that can streamline the transition from the research and development phase to production and sales.
Pharmaceutical, biotech, medical device and other life sciences companies are under increasing pressure to succeed in a highly competitive and regulated marketplace. There is no room for error, especially when delivering life-changing products to customers. An integrated business platform for ERP, CRM and BI can optimize operations, support all phases of growth and deliver the very data needed to succeed.
In our next article in the series of the 10 requirements Life Sciences companies need addressed by their industry specific ERP systems, we cover the next three capabilities: Inventory Storage, Quality Management, and Document Management.
(In our previous articles we covered: Traceability and As Built / As Maintained Configuration Record; Electronic Signatures, Engineering Change Notice, and Effectivity Dates and Phase-Ins.)
In this article, we continue the discussion of the 10 requirements Life Sciences companies need addressed by their industry specific ERP systems. In our last article, we identified the first two requirements – traceability and as built / as maintained configuration records.
In this blog post we will discuss three more requirements: Electronic Signatures, Engineering Change Notice, and Effectivity Dates and Phase-Ins.