Both business and IT stakeholders of Life Sciences organizations are realizing benefits of cloud computing through SAAS solutions like Workday, Salesforce, Veeva and other service providers.
However, they continue to be challenged when trying to establish on-demand infrastructure, software, and analytical resources for the organization. The primary challenge comes from regulations, compliance, privacy and security that affect the industry. This in turn presents a series of strategic considerations:
- What type of cloud configuration is right for the Life Sciences enterprise – “public”, “private” or “hybrid”?
- Which type of deployment allows the enterprise to be as compliant as on-premise solutions?
- How does the enterprise (Lifecycle) operate in this new environment?
The solution every Life Sciences organization is looking for in the context of Infrastructure as a Service is a Validated (establishing documented evidence that a process will consistently produce a product meeting its pre-determined specifications and quality attributes) and a Qualified (making sure the system behaves as expected in its actual production environment) infrastructure.
However, designing a validated infrastructure in the context of cloud is a complex, challenging task for any organization.
Some key considerations that go into building a validated cloud are:
- Ensuring the infrastructure (Network, Servers, Physical Host, Cluster, Storage, backup) is qualified and validated
- Ensuring that the application system serviced via this infrastructure adheres to Compliance regulation (GMP) based on scope of applications and infrastructure to be run in the environment
- Ability to produce appropriate documentation- (IQ, scripts, test plans and others)
- Process and Procedures including SOP’s and runbooks.
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