There is no shortage of compliance considerations for Life Sciences and Healthcare companies making preparations to move to the cloud.
How can they navigate moving to the cloud while mitigating risks? Well, you've heard the power of an ounce of prevention: Information Governance Strategy Assessments.
The reasoning behind a cloud migration isn't difficult to understand.
Moving electronic content and its management to the cloud drives great benefits in terms of reducing IT storage costs and support requirements, while providing substantial flexibility and scalability. These savings and benefits often introduce risks particularly for Life Sciences companies in terms of compliance, data privacy and information security. There is no short supply of of information governance and compliance considerations for Life Sciences firms planning cloud implementations, whether Software-as-a-Service (SaaS), Platform-as-a-Service (PaaS), or outsourcing your entire IT ecosystem to Infrastructure-as-a-Service (IaaS).
What's more, many cloud service organizations are not fluent in all pertinent areas of risk, so Life Sciences organizations must assess vendors against their own information governance programs.
For Life Sciences firms today considering moving to the cloud, top risks include the following - only some of which are included in most cloud impact assessments currently.
- GxP Compliance and SDLC Validation Documentation: Documented traceability between requirements and implementation, particularly regarding electronic signatures and audit trails.
- Records Retention Compliance: Mapping to corporte retention schedules to preserve or detroy records in compliance with the schedule.
- eDiscovery/ESI Compliance: Ability to apply holds to prevent alteration, migration and destruction of information.
- Data/Information Security: Demonstrated prevention of unauthorized access to systems and data and tracking users that have accessed systems and individual content.
- Data Management, Migration & Integration: Adherence to metadata standards and master data management to permit free movement of content between systems in and out of a particular cloud solution.
- Privacy, Risk Management & Vendor Transparency: Auditable and Active Reporting of data security and privacy breaches and ability to anonymize data.
Information Governance Strategy Assessments
Information Governance Strategy Assessments are low cost, short-term projects that enable an objective third party to partner with an organization to establish realistic success criteria for determining current state position and communicating future state needs in an easy-to-follow roadmap and implementation plan.
Ideally an assessment project is positioned before cloud services are contracted though most assessment and strategy approaches may be applied to existing cloud solutions, whether SaaS, PaaS, or IaaS. Components of an assessment project include, but are not limited to:
- Roadmap and implementation plan, including clear risk identification and mitigation activities to address gaps in circumstances where parts of an organization has already employed cloud solutions.
- Cloud deployment goal posts and objectives, identified and established early in the project and directly aligned with a company’s established information governance and records management programs and strategies.
- An actionable plan, whether remediation for existing deployments or an implementation plan for future activities.
Today, across the drug development process in the clear and transparent management of clinical trial and patient information, there is an escalating drive to provide free movement across geographic organizational borders - a best selling feature of cloud adoption. Concerns in facilitating this free movement include geographic, security, access, audit trail and logging issues, as well as data privacy and business resiliency.
With preventative measures and a structured approach, Life Sciences organizations can deploy Information Governance Strategy Assessments to realize the flexibility, security and value of strategically placing cloud into their framework.