Customer Relationship Management Blog
During the last 6 years, the FDA regulated medical device industry has faced revenue and profitability challenges. The result has been a search for new revenue and profitability, which has included looking for new sources of profit. The field service arm of these enterprises had traditionally been treated as a cost center and a business necessity supporting the sales function. Now, it is being transformed into a profit center, with a substantially new set of goals, tools and KPIs. The Medical Device industry had first responded to these trends by seeking the usual cost saving efficiencies in their manufacturing and…
During the last 6 years, the FDA regulated medical device industry has faced revenue and profitability challenges. The result has been a search for new revenue and profitability, which has included looking for new sources of profit. The field service arm of these enterprises had traditionally been treated as a cost center and a business necessity supporting the sales function. Now, it is being transformed into a profit center, with a substantially new set of goals, tools and KPIs. Multiple factors have been pressuring the medical device industry revenues and are likely to remain as concerns in the coming years.…
The business pressures of a consolidating life sciences industry and reduced margins pressure business leaders to demand ever more aggressive IT system delivery schedules, often absent well considered definition and assessment of the actual project scope, requirements, resources and regulatory impact. As a result, hasty business and IT project planning coupled with lack of time for consultation across disciplines sometimes causes gross underestimation of the IT and validation project plan milestones. While the most obvious symptoms of a problem validation project are failures occurring in the execution of test protocols, there are many other symptoms that validation practitioners are seeing…
The rapid advent of wirelessly networked mobile devices such as tablets and cell phones into FDA regulated business processes has created significant challenges for the legacy based IT platform qualification and validation regimens. These known-state validation frameworks were defined during the prevalence of dedicated single purpose backend IT resources, coupled with traditional PC based user interfaces. The evolution of IT infrastructures to virtual cloud processing, accessed through consumer devices controlled by highly proprietary vendor OS and application frameworks, means GxP life sciences qualification frameworks must cope with a dynamic state-less environment which challenges the very principles of the regulatory IT…
In the CRM practice, we routinely observe the underestimation of the regulatory impact on CRM system due to what appears to be routine integration projects with legacy systems. There is a general lack of awareness that when life sciences companies integrate the CRM system with legacy GxP systems, the CRM system becomes an extension of the regulated system As a result new requirements emerge for the management of the formerly unregulated CRM system, which may include the following components: CRM Platform qualification – hardware and software, which may be remotely hosted Application Validation – Selective based on function, or more…