Deploying a SharePoint Based eTMF in the Cloud

Presented by Paul Fenton President and CEO

/ 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!

/ Overview

• What is an eTMF

• What is Cloud computing

• Montrium Connect

• eTMF structure in SharePoint

• Document and records management in SharePoint 101

• Demonstration

/ 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

/ What is cloud computing?

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

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

/ Cloud Types

• Hardware and software resources are shared amongst all clients of the cloud

• Environments can be spread over multiple locations

• Clients cannot dictate on which machines their software and data reside

Public (Amazon,

Microsoft 365)

Private Shared

(Montrium Connect)

• Hardware and software resources are shared amongst all clients of the cloud

• Environments can be spread over multiple locations

• Clients can dictate on which machines their software and data reside

• Environment is controlled by one group

/ Cloud Types

Private Dedicated

• Hardware and software resources are dedicated to the owner of the cloud

• Environments can be spread over multiple locations

• Applications can be hosted by multiple machines

• Environment is controlled by one group

• Equivalent of a dedicated hosted envrionment

/ 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

/ 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

/ Records Management Workspace Overview

File Plan Taxonomy / Classification / Lifecycle Parameters / Publishing Profiles

Department A Doc Structures / Templates

/ Content Types / Columns

Department B Doc Structures / Templates

/ Content Types / Columns

Central File Structure eTMF structure, Final Records, TMF Export, Audit Trail

Adlib

Express Submission

Ready PDFs

Department B Doc Structures / Templates

/ Content Types / Columns

Department A Doc Structures / Templates

/ Content Types / Columns

Arx

CoSign Digital

Signatures

Workflow Engine / Montrium Web Services Document Lifecycle Process (DLP) / Unique Document

Numbering / Document Classification / Send to Central Files

eCTD

Software

/ 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

/ File Plan - Structure

Zone

Section

Document Type

Classification

Routing

Templates

Approval Type

Numbering Template

Document Type

Section Document

Type

/ File Plan Example

Study Management Files

Data Management

Data QC Plan

QCP, TMF=Y etc.

Peer Review=Y, Reg Review=N

Adlib Template=Clinical

eSignature

Numbering=Clinical

Annotated CRF

Protocols Clinical Protocol

/ 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

/ 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

/ 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

/ 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

/ Next Webinars

Case Study 2 – Implementing an Integrated Quality Management System in SharePoint

January 17th – 9am EST

January 19th – 2pm EST

/

Montrium North America 507 Place d’Armes, Suite 1050

Montreal (QC) H2Y 2W8 Canada

Tel. +1-514-223-9153 ext.206

Montrium Europe Avenue Louise, 475

1050 Brussels Belgium

Tel. +32.2.808.3008 ext.206

Contact Details

Paul Fenton

pfenton@montrium.com

www.montrium.com