September 10, 2015 | Written by: James McCormack
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For years, regulatory issues have made it difficult for the life sciences industry to take advantage of cloud computing’s myriad benefits. That’s likely to change with the introduction of IBM Watson Health Cloud for Life Sciences Compliance.
IBM’s latest offering provides a comprehensive cloud infrastructure solution to help life science clients take advantage of cloud computing. They can do this while maintaining their compliance program, providing validated and qualified cloud infrastructure, tools, and expertise.
Regulations governing the testing and manufacturing of drugs or medical devices are intended to assure that these products are safe and effective. Today, computerized systems are an essential and integral part of drug and medical device development and manufacture. To assure the integrity of data collected by life science companies and the quality of products, computerized systems must be tested to assure that they function reliably. Such testing includes:
- Qualification of the IT infrastructure on which software applications are run
- Validation of software applications that perform regulated activities
The key challenge around these requirements is having the skills, resources, capital, and time to deploy a qualified infrastructure and validated applications. This process can often take months, which can delay product releases and increase costs.
Anything a pharmaceutical or medical device company does that relies on a software application needs to be built on qualified infrastructure. IBM Watson Health Cloud for Life Sciences Compliance managed infrastructure as a service (IaaS) provides the platform for supporting all of those functions.
“The service lives in the cloud on SoftLayer’s bare metal infrastructure,” says Vinod Chavan, IBM Cloud Global Technical Solutions Executive. “This will give our clients the flexibility, scalability and control they need to bring innovation to market even faster.”
IBM Watson Health Cloud for Life Sciences Compliance is managed under a life science industry quality management system. This system includes trained personnel operating under the guidance of IBM’s Life Sciences Regulatory Center of Excellence, an incident, problem, and change management system, a document management system and a learning management system. These applications have been validated, which means they’ve gone through the rigorous testing and are operated under strict controls. This includes the cloud operation and management software, a major differentiator from other cloud service providers’ “black box” approach to cloud management software.
“Every client will get a private cloud on the dedicated bare metal servers with VPN connectivity to on-premises environments, enterprise grade performance and state of the art security capabilities,” Chavan says. “They will be able to add, change, retire virtual machines, networks and storage based on the business requirements.”
The new offering will allow clients to be more nimble by taking advantage of cloud computing’s on-demand flexibility and decreasing the time and expense required to provision and qualify infrastructure; ultimately accelerating time to market in developing new drugs and medical devices.
We foresee a wide range of applications that can be built on this IaaS, like customizable control systems, clinical trial management and analytics systems, and patient monitoring systems.
As with any industry, life sciences customers are interested in reducing costs. These companies can now take advantage of cloud’s pay-as-you go model, and they’re not beholden to hefty initial investments. We’ve heard from numerous life sciences customers that they want to use cloud as a utility. They want all of the advantages that cloud can offer—scalability, elasticity and on-demand service.
Because we’ve built it in a way that will support their compliance program, IBM Watson Health Cloud for Life Sciences Compliance makes cloud a reality for a vital field. The net result is a win-win: Patients can benefit from critical medical products faster. Pharmaceutical and medical device companies can reap profits sooner by getting their products to customers faster without compromising their compliance program.
James McCormack, Ph.D., is IBM’s Vice President of Life Sciences Compliance