There is an inherent benefit and decreased burden of risk with today’s cloud systems.
Cloud vendors are now performing much of the upfront groundwork for their customers when it comes to qualification and validation, making it easier to onboard new applications and leverage the vendor’s validation activities.
1. The Cloud is Compliant
It is now possible and prevalent in the Life Sciences community to utilize cloud systems and processes to perform the complex and regulated (including 21CFR Part 11) business cases inherent to the industry, including but not limited to:
- Drug manufacturing and distribution
- Sample Management
- Document Management
- Quality Control
- Field servicing of medical devices
- Patient adverse event reporting and dispositioning
2. Saves Your Business Money (Reduces Cost of Ownership)
Moving your business to the Cloud lowers multiple costs including: IT costs, payroll costs, and capital costs (i.e. no infrastructure and minimal administration). You also pay only for “what you need” and can add users and functionality as your organization grows.
3. Security and Recovery
The Cloud secures large amounts of data to ensure the safety and privacy of your business. The cloud also allows for disaster recovery and rescue. Leading cloud vendors operate and maintain world-class data centers that are subject to continuous audits and regulations. The security and disaster recovery equipment and processes within these data centers is monitored 24×7 by teams of security experts to make sure your applications and data are always available with minimal downtime.
4. Automated Self-Service and Always Up to Date
IT help and service is minimized as the Cloud is regulated with automatic updates that are rigorously tested and documented under formal change control that can then be tested according to risk by end users, prior to production release.
5. Work from Anywhere
The Cloud can be accessed from anywhere, not just your home office or through a VPN. Cloud applications are also “mobile friendly,” delivering real time synchronized data availability and functionality in the field.
6. Scalability and Agility
Cloud applications are built on open platforms which allow for easier integration with other systems. Almost all cloud vendors offer APIs or connectors to their applications so multiple applications can seamlessly share data and processes.
The Cloud allows business services and applications to be implemented and configured in less time and with greater efficiency – taking advantage of the common “Core Platform” and supplier activities around compliance and implementation.
9. Best Practice Business Processes
Cloud systems are based upon extensive and specialist business use cases that have been developed over time to incorporate the needs of Life Sciences companies. This has led to the use of best practice techniques – inherent and built in to the software. Cloud applications are the most up-to-date versions of software. They provide the functionality necessary to drive best practices in the Life Sciences industry.
10. Efficient Collaboration
Shared files and documents held in the Cloud allow for easier backup, storage, version control, and collaboration.
USDM Life Sciences provides strategy and compliant technology solutions to regulated life sciences companies and makes it easy to accelerate digital transformation and innovation. USDM Life Sciences focuses exclusively on the regulated biotechnology, pharmaceutical, and medical device industries and is a compliance partner with the world’s top technology software developers. For more information, visit usdm.com