Bruce Maches provides a thorough examination of the complexity and resource requirements of specialized life science applications and what the role (and challenges) will be as cloud continue to enter into the industry. Many life science companies are struggling to afford to internally build, implement, and support much of the required systems and infrastructure but as Maches argues, there are alternatives.
Any life science company looking to validate cloud based systems must adjust its system qualification process to properly prove to any auditor that the application in question is installed, operating correctly while also meeting the users requirements.”
To support large scale clinical trials, life science CIOs must deal with the challenges of provisioning and supporting vital hardware and software infrastructure. While there are a number of applications for managing clinical trials many life science companies are looking to cloud based offerings to reduce complexity and cost.
Given the costs and high level of risk it is common for life science companies to work jointly on research efforts. Cloud-based tools are already making this possible while still adhering to the numerous compliance and security requirements from the FDA.
With the recent FDA rulings governing how sales can interact with doctors, the importance of a CRM system to track the complex customer interactions has never been more critical.
The FDA, like many other regulatory bodies does not issue standards; instead it provides guidelines on what must be done to be considered compliant but not on the execution of how it is accomplished.