Deploying and Managing Microsoft SQL Server PowerPivot for SharePoint
Case Study – Deploying SharePoint Based eTMF in the Cloud
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Transcript of Case Study – Deploying SharePoint Based eTMF in the Cloud
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
www.montrium.com