Versions Compared

Old Version 68

changes.mady.by.user Kerry Robson

Saved on

compared with

New Version Current

changes.mady.by.user Kerry Robson

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

Image Modified


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

(

, NNIT

)

avid@nnit

anders@vidstrup.

comKatie Warren (

dk

Kerry Robson, PHUSE Project Assistant
)
katie@phuse

kerry@phuse.global

Objectives & Deliverables

Timelines

Publish draft White PaperQ22022


Status
colourBlue
titleCurrent Status
Q1

/22022

Reviewing updates to cloud documents set.

2024 

This quarter, the definition of the term exit strategy must be in place including the main structure of the document. Sub-chapters to be assigned to group members

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 SheoranBayerBob StreitJohnson & Johnson Technology QualityCatherine LiFDAChris WhalleyIndustryDan DziadiwMerckEvi CohenAppianEunice NdunguMerckHans Peter-SchreiterEntimoKarthik MNovo Nordisk Lynn CaldwellPfizerSerena PiersonAccentureStuart WardIDBSSuzanne StudingerQAS



Objectives & Deliverables

Timelines

Updated main document - Preamble Q3 2022


Published Deliverables

Cloud Framework – Audit Activities

1-Jul-2022

Cloud Adoption – Framework Documents: Version 4.0

  • To include, Preamble, Audit Activities, Regulatory Requirements, Terminology.

24-Apr-2019

Cloud Framework, Pre-Amble

27-Nov-2023
William TelfordSanofi