Failure to understand the unique requirements of this regulated industry creates a significant barrier for SaaS companies. The result? Great SaaS applications that fall short on proving their ‘fit-for-purpose’ for Life Sciences.
To be successful in the Life Sciences Industry, great SaaS applications must demonstrate they are great Validated SaaS Applications, and this demonstration begins at the very foundation of your applications – your cloud infrastructure.
In order to build Validated SaaS applications, one demand of the regulations is that your cloud application has been developed and deployed on foundational qualified infrastructure which is fit for purpose for life sciences. It is also vital that you don’t lose sight of your cloud infrastructure compliance status as you continue to develop new features, deploy new versions and expand and grow your business.
So how do you achieve this?
Odyssey VC has developed a clear roadmap for cloud compliance allowing companies to easily navigate this complex regulatory landscape. Whether it is simply an initial assessment of your current infrastructure quality, qualification of your new or existing cloud environment, support with fit-for-purpose infrastructure deployment or you require ongoing management of your entire qualified cloud infrastructure, Odyssey VC has the solution your SaaS business needs to drive forward in Life Sciences.
Roadmap to Qualified Infrastructure
- Assessments: Capture a compliance baseline.
Odyssey VC undertake a number of activities designed to deliver a ‘fit for purpose’ Assessment Report. This report offers your business the most comprehensive baseline of your current cloud compliance gaps, risks and opportunities.
Activities Include: Supplier / Vendor Assessments, Risk Assessments, Qualification Gap Assessments, Quality Systems Assessments.
- Qualification: Evidence Based and Auditable
Odyssey VC take care of tasks relating to the qualification of your current cloud infrastructure ensuring you are both within regulatory guidelines relating to your infrastructure and are equipped to easily address the requirements of your life sciences customer.
Activities Include: Configuration Management, Data Management, Access Management Controls, Leveraging and Aligning 3rd Party Vendor Processes, Business Continuity and Disaster Recovery and Audit Trail Implementation.
- Deployment
Odyssey VC support the deployment of your qualified cloud infrastructure.
Activities Include: Verification testing, Post Deployment Validation and Post Deployment Transfer
What if you don’t have cloud infrastructure in place yet?
Many Odyssey VC clients began their journey with us with one specific ask? Is there any way to bypass the need to qualify public infrastructure? This is where CompliantCloud comes in. CompliantCloud from Odyssey VC is a cloud hosting platform that has been designed specifically to meet the regulations and guidelines of the industry, offering a seamless and secure infrastructure to support life science cloud applications.
By working with a cloud platform that is ‘fit-for-purpose’ by design, the additional assessment, qualification, and risk-based deployment steps required when working with traditional public cloud providers are eliminated. This offers a more direct route to deployment, streamlining the compliance and validation elements and ultimately decreasing the product release lifecycle.
Cloud Infrastructure Management
For many organisations, the ongoing management of infrastructure becomes a prohibitive cost to software development. Odyssey VC’s Cloud Infrastructure Management, looks after your ongoing monitor and control activities as well as your review and continuous improvement needs.
Activities Include: Patch management, Change Management, Access Management, Security Management, Incident Management, Periodic Reviews, Policy and Documentation Reviews, Client and Vendor Management Reviews, Disaster Recovery Checks and Verification
By availing of our Cloud Infrastructure Management, many of our clients have freed up precious resources, allowing them to focus on their core business without jeopardising the maintenance of their qualified state, a key requirement in the industry.
Ensuring your cloud infrastructure is safe, secure and qualified is a priority when operating in a GxP environment. While this has often been viewed as a barrier for SaaS adoption in the industry, working within a qualified infrastructure can offer the SaaS provider a real competitive advantage within the Life Sciences market.
