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Project Scope

Cloud technology and its use of multi-tennant app solutions are increasing the capabilities of Life Sciences solutions and reducing IT infrastructure costs through the sharing of infrastructure and investment cross-industry.

In some areas multi-tenant cloud solutions have become ubiquitous. For example, Salesforce.com 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 Life Sciences industry must conduct its business still leave many uncertain about whether or not they can (or should) pursue the use of Cloud solutions for GxP applications.

The goal of this project has been to provide a practical, usable framework to overcome those barriers. Through the use of this framework, it is envisaged that the barriers to adoption by Pharma of Cloud-based technology will be addressed.




Project LeadsEmail

Anders Vidstrup

avid@nnit.com

Paula Rowley (PHUSE Project Assistant)paula@phuse.global 


Objectives & Deliverables

Timelines

Finalise Chapters and send for internal review.Q12021
Publish final framework.Q12021


Status
colourBlue
titleCurrent Status
Q3/42021

Reviewing updates to cloud documents set.


Published DeliverablesDate

Cloud Adoption - Framework Documents: Version 4.0

  • To include, Pre Amble, Audit Activities, Regulatory Requirements, Terminology.

24-Apr-2019


The team has representatives from SaaS, PaaS and IaaS providers, as well as 'consumer organisations' Stakeholders. This project has generated value for several levels of stakeholders.

  • For the wider audience interested in knowing what is possible in Cloud computing, it has generated use cases that illustrate the successful implementations, or pitfalls, in the use of Cloud-based technology.

  • For IT professionals it has generated 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 provides a clear mapping between technology capabilities and regulatory requirements.



Project Members

Organisation

Anupama SheoranBayer
Bob StreitJohnson & Johnson Technology Quality
Catherine LiFDA
Chris WhalleyIndustry
Dan DziadiwMerck
Evi CohenAppian
Eunice NdunguMerck
Hans Peter-SchreiterEntimo
Lynn CaldwellPfizer
Serena PiersonAccenture
Stuart WardIDBS
Suzanne StudingerQAS
William TelfordSanofi