This document will discuss: - What is an eTMF - What is Cloud computing - Montrium Connect - eTMF structure in SharePoint - Document and Records Management in SharePoint 101 - Demonstration

1. Deploying a SharePoint Based
eTMF in the Cloud
Presented by Paul Fenton
President and CEO

2. / SharePoint for Pharma Series
• Webinar series that aims to highlight the different aspects
of validation and using SharePoint in GxP environments
• 4 different sessions covering the different aspects of
deployment, use and validation of SharePoint
• Should provide attendees with a good grounding for their
SharePoint projects
• Slides can be distributed upon request. Details on how to
request slides will be distributed to attendees following each
webinar.
• Thank you for your interest!

3. / Overview
• What is an eTMF
• What is Cloud computing
• Montrium Connect
• eTMF structure in SharePoint
• Document and records management in SharePoint
101
• Demonstration

4. / What is an eTMF?
• An electronic archive which stores all records that are
required to reconstruct and describe events relating to the
conduct of a clinical study
• An inspectable set of essential documents that meet GCP
requirements and ALCOA
• A system which needs to meet regulatory requirements for
electronic records and in some cases electronic signatures
(21 CFR Part 11)
• A collaborative environment for the authoring, review,
approval, organization and archiving of documents and
records

5. / What is cloud computing?
Definition: Cloud computing is the delivery of computing as
a service rather than a product, whereby shared resources,
software, and information are provided to computers and
other devices as a utility (like the electricity grid) over
a network (typically the Internet) – Wikipedia
Definition: The practice of using a network of remote
servers hosted on the Internet to store, manage, and
process data, rather than a local server or a personal
computer – English Oxford Dictionary

6. / Cloud Types
• Hardware and software resources are shared
amongst all clients of the cloud
Public
(Amazon, • Environments can be spread over multiple
Microsoft 365) locations
• Clients cannot dictate on which machines
their software and data reside
• Hardware and software resources are shared
amongst all clients of the cloud
Private • Environments can be spread over multiple
Shared locations
(Montrium
Connect)
• Clients can dictate on which machines their
software and data reside
• Environment is controlled by one group

7. / Cloud Types
• Hardware and software resources are
dedicated to the owner of the cloud
• Environments can be spread over multiple
Private
locations
Dedicated
• Applications can be hosted by multiple
machines
• Environment is controlled by one group
• Equivalent of a dedicated hosted
envrionment

8. / Challenges to Cloud Computing in Life
Sciences
• Regulatory compliance requires that the whole
computerized system (Hardware and Software) is qualified
and controlled – difficult with a public cloud
• Shared resources can pose potential security and
confidentiality problems
• Public clouds are not designed to be compliant with 21 CFR
Part 11
• Private dedicated clouds are expensive and not accessible to
smaller companies

9. / Montrium Connect
• Fully qualified and validated SharePoint environment for
management of GxP operations
• Targeted towards smaller entities
• Comes preconfigured based on industry standards,
regulations and best practices
• Can be used for document and records management
(including eTMF) and quality management
• Based on a per user per month fee
• Includes automated workflows and digital signatures
• Can be deployed within a matter of days

10. / Records Management Workspace Overview
File Plan
Taxonomy / Classification / Lifecycle Parameters / Publishing Profiles
Department A Department B Arx
Department A Department B CoSign
Doc Structures / Templates Doc Structures / Templates
Doc Structures / Templates Doc Structures / Templates Digital
/ Content Types / Columns / Content Types / Columns Signatures
/ Content Types / Columns / Content Types / Columns
Adlib
Workflow Engine / Montrium Web Services Express
Document Lifecycle Process (DLP) / Unique Document Submission
Numbering / Document Classification / Send to Central Files Ready PDFs
eCTD
Central File Structure Software
eTMF structure, Final Records, TMF Export, Audit Trail

11. / File Plan
• Allows the construction of a central taxonomy for
all records
• This taxonomy is used to:
– Create all document management structures for each
department
– To create content types (document types) and metadata
– To automatically classify and identify documents
– To determine document lifecycle
– To apply PDF publishing templates
• Baseline taxonomy mapped to EDM/TMF Reference
Model

12. / File Plan - Structure
Classification
Routing
Document
Templates
Type
Section
Document Approval
Zone Type Type
Document Numbering
Section
Type Template

13. / File Plan Example
QCP, TMF=Y etc.
Peer Review=Y, Reg
Review=N
Adlib
Data QC Plan
Template=Clinical
Data Management
Annotated CRF eSignature
Study
Management Files
Protocols Clinical Protocol Numbering=Clinical

14. / Document LifeCycle
• Series of automated workflows to manage the
lifecycle of each document/record
• Document Status and routing is managed
automatically
• Links automatically generated PDF renditions to
source documents
• Automatically sends final records to Central Files
structure
• Improves control and enhances collaboration

15. / Unique Document Identifier
• Automatically generates a unique identifier for
each document based on a predefined
nomenclature
• Nomenclature is composed of concatenated
metadata values and unique sequential numbers
• Nomenclature standards are linked to numbering
tags which are then associated to document types
in the file plan
• If a document type changes, it will be renumbered
• Unique identifiers cannot be reused

16. / Adlib Publishing Templates
• Predefined PDF publishing parameters are centrally stored
in XML templates
• Document types are associated to publishing templates in
the file plan
• Publishing templates are submitted automatically with
documents to the Adlib Express server
• Publishing parameters include:
– TOC
– Hyperlinks
– Formatting
– Watermarks

17. / Central Files (Record Center)
• Central site which is used to store final records from all
departments
• Central file structure is based on file plan
• Predefined views allow easy navigation to find records
• Can be organized by product or by study
• eTMF can be extracted in Windows explorer and written to
durable media
• Listing of records with metadata can be extracted in Excel.
Other formats currently being considered

18. / Next Webinars
Case Study 2 – Implementing an Integrated Quality
Management System in SharePoint
January 17th – 9am EST
January 19th – 2pm EST

19. / Contact Details
Paul Fenton
pfenton@montrium.com
Montrium North America Montrium Europe
507 Place d’Armes, Suite 1050 Avenue Louise, 475
Montreal (QC) H2Y 2W8 1050 Brussels
Canada Belgium
Tel. +1-514-223-9153 ext.206 Tel. +32.2.808.3008 ext.206
www.montrium.com