Cloud Adoption in the Life Sciences Industry

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Lowering Barriers to the Adoption of Cloud Technology

Project Scope

Cloud technology and multi-tennant cloud solutions are increasing the capabilities of Pharmaceutical R&D IT solutions and reducing Pharmaceutical R&D IT infrastructure costs through the sharing of infrastructure and investment cross-industry. In some areas multi-tenant cloud have become ubiquitous. For example, claim >150K customers utilize their platform for Customer Relationship Management. Furthermore, many routinely rely on cloud services associated with their computer backups and data services associated with cell phones. Nonetheless, the perceptions and interpretations of the regulations by which the pharma industry must conduct its business still leave many in the industry uncertain about whether or not they can - or should - pursue the use of cloud solutions for GxP validated applications. The goal of this workstream is to take small, concrete steps to determine where there are real barriers to the use of cloud-based solutions and where there are technical solutions to overcome those barriers. Through the publication of use cases, best practices, and decision trees this group will lower the barriers to adoption by pharma of cloud-based technology, focus attention on areas of regulation that are causing the greatest concern, and focus industry investments on solving the major technical challenges that are outstanding.

In Scope

The use and the potential use of cloud-based systems to support business processes within the regulated domain of the biopharmaceutical industry Data privacy regulation Openly available technology solutions

Out of Scope

Commercial terms, internal company processes, vendor-specific products or solution

Project Team Members

List team leads and team members. Identification of a project manager is recommended.

Project Team Members

A project team lead is needed. A cross-functional team would be ideal for overall success with expertise across

  • Cloud technology & IT infrastructure
  • Systems Validation & Quality Assurance
  • The Regulatory framework constraining pharma business processes
  • Information Protection and IT Security
  • Legal
  • Patents
  • Procurement

-R&D IT Applications Expertise

Affected Stakeholder

This workstream will generate value for serveral levels of stakeholder:

  • For the wider audience - interested in knowing what is possible in cloud computing - it will generate use cases that illustrate the successful implementations or pitfalls in the use of cloud-based technology.
  • For the IT professionals it will generate information materials that help to guide efforts to implement quickly, and in regulatory compliance, cloud technologies as well as providing decision trees to support technology decision making.
  • For the regulatory professionals it will provide a clear mapping between technology capabilities and regulatory requirements.

Project Meeting Frequency

TBD – will depend on the number of participants, timelines, individual commitments, and team structures

Deliverables and Dates:

Objective Action Deadline
Use Cases a template will be defined and published by the end of August soliciting examples of successful validated cloud solutions. All use cases will be maintained Cloud Lowering Barriers Use Cases. August 2013
Regulatory Hurdles the team will publish a list of specific challenges in meeting regulatory requirements in multi-tenant cloud solutions. The list of regulatory hurdles citing specific regulation and how this is challenging to groups validating multi-tenant, hosted solutions September 2013
Regulation to Technology Map the team will publish a map connecting “regulatory requirements” to “purpose” to the variety of technical solutions that define best practices. October 2013
Technical hurdles the team will publish a list of specific technical challenges which are currently unsolved with recommendations for how they could be addressed by a cross-industry group November 2013
Information Refresh Process the team will propose a specific approach to refreshing the content of its documentation as technology and regulatory environments evolve. TBD

Original file document Media:Lower_Barriers_to_the_Cloud_2013_06_14.doc Lower Barriers to the Cloud

Last revision by DanBoisvert,06/27/2013