Moving your existing environment to manage regulated content in a new Office 365 environment requires a rigorous amount of attention to detail, and any overlook can lead to more significant problems down the road. Whether you’re coming from working within legacy applications or pre-existing infrastructure, you must take the right precautions. When deploying GxP processes in Office 365, you will need to leverage a deployment approach that can address both technical considerations while accounting for the distinctions in your organizational culture and specific user requirements.

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• Headquartered in Montreal, Canada
• EU HQ in Brussels
• Clients in North America, Europe & Asia
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4. K E Y G X P C O N S I D E R A T I O N S F O R
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5. Increase control and
efficiency of GxP
business processes
and help manage the
lifecycle of GxP
records
Optimizes the creation of GxP records by allowing users to collaborate
simultaneously while maintaining control over the record source
Ensures business processes are followed in controlled and
consistent manner
Reduces human error by automating repetitive tasks
Can be adapted as business needs change
Leverages built-in capabilities of the Office 365 platform to minimize
costs and risks associated with system changes

6. Office 365 Feature How Flow can be used
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Flow can be especially useful in
supporting our ability to adhere
to these regulatory requirements

8. FDA - Data Integrity and Compliance With CGMP Guidance
for Industry, April 2016
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9. Validation of individual GxP
business processes
•Each GxP site should be
provisioned in accordance with
standard provisioning process.
•Each automated GxP business
process should be validated to
demonstrate that it is fit for its
intended use.
Validation of core Office 365
content management
features
•Verify configuration and
functionality of "out-of-the-box"
features that support electronic
records management
Office 365 / SharePoint Online Baseline Validation
("out-of-the-box" features)
GxP Business Process
Validation
GxP Site / Flow (n)
GxP Business Process
Validation
GxP Site / Flow (n+1)

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GxP Business Processes
GxP Business Process 1
GxP Business Process 2
GxP Business Process 3
GxP Business Process 4
GxP Business Process 5
GxP Business Process n
GxP Business Process
n+1
Business Needs Analysis / Requirements Gathering
GxP Impact and Risk Analysis
Specification and Design
Development
Deployment (TEST & PROD)
Validation (User Acceptance Testing)
For each GxP
business process
Governance

11.  Ensure only authorized individual can make
changes to GxP Flows
 Ensure procedures are in place for monitoring,
administering and making changes to GxP
Flows
 Ensure proper training and qualification of
individuals involved in the development and
administration of GxP Flows
 Implement controlled processes to manage
the versioning and backup of Flows
 Perform periodic reviews to ensure the
change management process has been
followed and that the Flow remains in a
validated state
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12. G E T T I N G S T A R T E D W I T H
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13. Flow allows you to automate GxP processes
where specific sequencing of events or activities
are required
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1 Trigger Flow from library ribbon
2 Trigger Flow from document context
menu3
Trigger Flow using a button which
has been created using the custom
Column Formatting feature

16. Flow has many Standard actions which allow actions to be
performed on content stored within SharePoint Online
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Flow comes with many templates
that are freely available, which can
be used as starting point when
designing a new Flow
Note: The Send an HTTP
request to SharePoint action
can be used with REST API if the
required action is not built-in.

17. Adobe Sign connector enables users to
automatically send and sign documents using 21
CFR Part 11 compliant electronic signatures

19. • Establish good Flow design practices to
ensure quality and consistency in terms of
design and naming conventions of Flows
• Define process for packaging Flows and
moving them from one environment
• GxP Flows should be tested in a testing
environment before importing them into
the production environment
• License requirements, a paid account may
be required for certain Flow processes
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22. The following are some of the administrative tasks that can be
automated through PowerShell scripting:
• Site provisioning
• Extraction and application of site templates (PnP or Site
Design Scripts)
• Power Automate commands (formerly Flow)
• Assignment of licenses
• Custom permission creation
• Users can be assigned to appropriate security groups
based on their roles and responsibilities.
• Creation of retention labels in the O365 Security
and Compliance Centre
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26. D E S I G N O V E R V I E W
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GxP Processes Process steps
GxP Document lifecycle
management
Document drafting  review  approval  withdrawal
Incident management Incident submission  investigation  close-out
GxP system change
management
Change request  impact evaluation  pre-implementation
approval  implementation  post-implementation approval
Clinical data transfer using
SFTP
Dataset upload to SFTP  transfer to SPO  review and QC
Validation test script execution
and review
Test script execution  review  approval
Batch Production Record
review & release management
Bath record upload  review  approval for release

28. Security and
Compliance
Center
On prem
Active
Directory
Users
Web Mobile
HTTPS/SSL
Azure AD
Office 365
Azure AD
Connect
GxP
Collaborative
Work
Area(s)
GxP
Records
Archive
GxP Business
Process
Workflows
Test Site 1Production Site 1
Integrated 3rd Party Solutions
(e.g. Electronic Signatures)
API
SharePoint Online
• Unified audit log
• Record retention labels
• Sensitivity labels
• User identity management
and access control
• Multi-factor authentication
GxP
Collaborative
Work
Area(s)
GxP
Records
Archive
GxP Business
Process
Workflows

29. - Departmental Team Site (Medical
Writing)
- User Access Control List: Location
where users can be assigned to
appropriate security groups based on
their roles and responsibilities
- Site Provisioning List: List for initiating
study structure provisioning process
- Therapeutic Area Site: Team site for
collaborating on study documents
• Study Libraries: Access controlled
location where users collaborate
throughout the document lifecycle
SharePoint Online Tenant
Si

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32. Programming
Narrative
Coordinator
Writing
Resource
Clinical
Reviewer
NarrativeQC
Reviewer
Document
Specialist
Contribute Contribute Read Read Read No Access
No Access Contribute Contribute No Access Contribute No Access
No Access Contribute No Access Contribute No Access No Access
No Access Contribute Read Read Read Read
No Access Contribute Read Read Read No Access
No Access Contribute Contribute Contribute Contribute No Access
No Access Contribute No Access No Access Contribute No Access
Process Roles

33. Final
Ready to be Finalized
Review Complete
Ready for QC Review
Ready for Clinical Review
Draft
Status column indicates
stage of the narrative
lifecycle

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