Deploying a SharePoint BasedeTMF in the CloudPresented by Paul FentonPresident and CEO
/ SharePoint for Pharma Series • Webinar series that aims to highlight the different aspects   of validation and using Sha...
/ Overview• What is an eTMF• What is Cloud computing• Montrium Connect• eTMF structure in SharePoint• Document and records...
/ What is an eTMF? • An electronic archive which stores all records that are   required to reconstruct and describe events...
/ What is cloud computing?Definition: Cloud computing is the delivery of computing asa service rather than a product, wher...
/ Cloud Types                    • Hardware and software resources are shared                      amongst all clients of ...
/ Cloud Types                • Hardware and software resources are                  dedicated to the owner of the cloud   ...
/ Challenges to Cloud Computing in Life  Sciences • Regulatory compliance requires that the whole   computerized system (H...
/ Montrium Connect • Fully qualified and validated SharePoint environment for   management of GxP operations • Targeted to...
/ Records Management Workspace Overview                                 File Plan     Taxonomy / Classification / Lifecycl...
/ File Plan • Allows the construction of a central taxonomy for   all records • This taxonomy is used to:    – Create all ...
/ File Plan - Structure                                      Classification                                        Routing...
/ File Plan Example                                                          QCP, TMF=Y etc.                              ...
/ Document LifeCycle • Series of automated workflows to manage the   lifecycle of each document/record • Document Status a...
/ Unique Document Identifier • Automatically generates a unique identifier for   each document based on a predefined   nom...
/ Adlib Publishing Templates • Predefined PDF publishing parameters are centrally stored   in XML templates • Document typ...
/ Central Files (Record Center) • Central site which is used to store final records from all   departments • Central file ...
/ Next Webinars    Case Study 2 – Implementing an Integrated Quality            Management System in SharePoint           ...
/ Contact Details                        Paul Fenton                  pfenton@montrium.com         Montrium North America ...
Upcoming SlideShare
Loading in …5
×

Case Study – Deploying SharePoint Based eTMF in the Cloud

1,840 views

Published on

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

0 Comments
2 Likes
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total views
1,840
On SlideShare
0
From Embeds
0
Number of Embeds
27
Actions
Shares
0
Downloads
41
Comments
0
Likes
2
Embeds 0
No embeds

No notes for slide

Case Study – Deploying SharePoint Based eTMF in the Cloud

  1. 1. Deploying a SharePoint BasedeTMF in the CloudPresented by Paul FentonPresident and CEO
  2. 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. 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. 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. 5. / What is cloud computing?Definition: Cloud computing is the delivery of computing asa service rather than a product, whereby shared resources,software, and information are provided to computers andother devices as a utility (like the electricity grid) overa 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. 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. 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. 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. 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. 10. / Records Management Workspace Overview File Plan Taxonomy / Classification / Lifecycle Parameters / Publishing Profiles Department A Department B Arx Department A Department B CoSignDoc 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 SubmissionNumbering / Document Classification / Send to Central Files Ready PDFs eCTD Central File Structure Software eTMF structure, Final Records, TMF Export, Audit Trail
  11. 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. 12. / File Plan - Structure Classification Routing Document Templates Type Section Document Approval Zone Type Type Document Numbering Section Type Template
  13. 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 StudyManagement Files Protocols Clinical Protocol Numbering=Clinical
  14. 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. 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. 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. 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. 18. / Next Webinars Case Study 2 – Implementing an Integrated Quality Management System in SharePoint January 17th – 9am EST January 19th – 2pm EST
  19. 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

×