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 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 Life Sciences industry must conduct its business still leave many uncertain about whether or not they can - (or should - ) pursue the use of cloud Cloud solutions for GxP applications. The goal of this work stream 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 Pharma of cloudCloud-based technology will be addressesaddressed. |
| Project Leads | Email |
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Anders Vidstrup, NNIT |
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| Alex Pearce, PHUSE Project |
Objectives & Deliverables | Timelines| Finalise Chapters and send for internal review | Q12021 |
| Publish final framework | Q12021 |
| Status |
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| colour | Blue |
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| title | Current Status |
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- Draft of 2 appendix ongoing and will be shared with project members for feedback in by end of April.
- Will consolidate and then update the appendix.
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| Published Deliverables | Date |
Cloud Adoption - Framework Documents: Version 4.0 To include, Pre Amble, Audit Activities, Regulatory Requirements, Terminology
| 24-Apr-2019 |
| Cloud Webinar | November 2018 |
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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 |
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. |
, it has generated use cases that illustrate the successful implementations, or pitfalls, in the use of
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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.
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Project Members | Organisation |
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| Anupama Sheoran | Bayer |
| Bob Streit | Janssen Research & Development |
| Catherine Li | FDA |
| Chris Whalley | Industry |
| Dan Dziadiw | Merck, Sharp & Dohme |
| Evi Cohen | Appian |
| Eunice Ndungu | Merck, Sharp & Dohme |
| Hans Peter-Schreiter | Entimo |
| Lynn Caldwell | Pfizer |
| Martijn Van Beelen | GSK |
| Andrew Matteson | Applied Biomath |
| Pieter Stas | Business & Decision Life Science |
| Raechelle Raimondo | Allergan |
| Richard Martinez | RHO World |
| Rocco Timpano | Pfizer |
| Sandy Estrada | Cervello |
| Serena Pierson | Accenture |
| Stuart Ward | IDBS |
| Suzanne Studinger | QAS AG |
Objectives & Deliverables | Timelines |
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| Updated main document - Preamble | Q3 2022 |
William Telford | Sanofi