Emerging Technologies Project Plan Template
1. Project Title:
Lowering Barriers to the Adoption of Cloud Technology
2. 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, 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 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.
1. 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
2. Out-of-Scope:
Commercial terms, internal company processes, vendor-specific products or solution
3. Project Team Members
List team leads and all team members. Identification of a project manager is recommended
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
4. 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 cloudbased 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.
5. Project Meeting Frequency:
Could include Resources, staff, other projects, etc
TBD – will depend on the number of participants, timelines, individual commitments, and team
structures
6. Project Objectives and Timeline:
Deliverable 1: Use Cases – a template will be defined and published by the end of August 2013
August soliciting examples of successful validated cloud solutions. All use cases
will be maintained in the PHUSE WIKI
Deliverable 2: Regulatory Hurdles – the team will publish a list of specific September 2013
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
Deliverable 3: Regulation to Technology Map – the team will publish a map October 2013
connecting “regulatory requirements” to “purpose” to the variety of technical
solutions that define best practices.
Deliverable 4: Technical hurdles – the team will publish a list of specific technical November 2013
challenges which are currently unsolved with recommendations for how they could
be addressed by a cross-industry group
Deliverable 5: Information Refresh Process – the team will propose a specific TBD
approach to refreshing the content of its documentation as technology and
regulatory environments evolve.
Deliverable 3: Regulation to Technology Map
Purpose: Backup / Data Protection
Some of the Applicable Regulations [Note: by no means complete – for example use]
The Rules Governing Medicinal Products in the European Union
Volume 4 - Good Manufacturing Practice - Medicinal Products for Human and Veterinary Use
http://ec.europa.eu/health/files/eudralex/vol-4/annex11_01-2011_en.pdf
Annex 11: Computerised Systems
Operational Phase

7. Data Storage
o
7.2
21 CFR Part 11 - Electronic Records; Electronic Signatures
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=11
Subpart B--Electronic Records

11.10 Controls for Closed Systems
o
11.10 (c)
21 CFR Part 58 - GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY
STUDIES
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=58
Subpart J--Records and Reports

58.185 - Reporting of nonclinical laboratory study results.

58.190 - Storage and retrieval of records and data.

58.195 - Retention of records.
21 CFR Part 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED
PHARMACEUTICALS
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=211&showFR=1
Subpart D—Equipment

211.68 Automatic, mechanical, and electronic equipment.
o
68a/68bControls: (examples)
Technology Solutions


Data Backup SOP Include Backup Schedule, Execution, Monitoring, Testing, Storage
Technology options: tape, spinning disc, cloud storage, CD