Life Sciences Organizations Succeed Under Pressure with Digital Transformation

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.

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Planning Ahead for Compliance

There is so much to consider during an ERP implementation, isn’t compliance something that can be attacked once everything else is in place? Compliance is a combination of people, processes, and software. Since these same components are part of a successful ERP implementation, it just makes sense to consider both at the same time. A good implementation focuses on more than just installing hardware and software; it considers how that software will complement the way things get done. And keeping track of how things get done (and making sure these processes meet internal and external expectations) is the dominion of compliance.

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What Keeps You Up at Night? 2014 in Review for Medical Device Companies

Quality compliance is never a static concern. With changes in programs and new guidance documents it may feel like trying to hit a moving target. During online discussions, many device manufacturers indicated that their areas of biggest concern were inspections, followed by product recalls, warning letters, UDI implementation and CAPA. Clearly, no one is alone in their concerns.

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