SharePoint for Pharma Webinar Series

April 26th 2011 –11am-12pm EDT – Validating SharePoint 2010 for Regulated Life Sciences Applications

Presented by Paul Fenton, President and CEO, Montrium Inc.

Webinar Overview:

When used as a system for managing regulated content and processes, SharePoint is subject to the requirements of 21 CFR Part 11 and related requirements. During this session we will review the approaches being taken by companies to validate their SharePoint environments, and emerge with a set of guidelines for a risk-based validation strategy for SharePoint 2010. You will gain a clear understanding of why, when Validating SharePoint for Regulated Life Sciences Applicationsand how to validate SharePoint, and there will be a strong focus on reducing the time, cost and resources required to validate a SharePoint environment whilst providing maximum quality, control and ROI. We will also review a standard set of validation documents contained within Montrium’s SharePoint validation pack which can be used as a baseline to qualifying SharePoint for regulated environments.

Among the topics included will be:

• Managing and validating a mixed SharePoint environment that includes both controlled and non-controlled SharePoint environments
• Developing a risk based validation strategy for SharePoint 2010 applications
• How to manage 21 CFR Part 11 electronic records and electronic signatures in SharePoint 2010
• A Step by Step overview of standard validation documentation and approaches contained within Montrium’s SharePoint 2010 validation pack
• Implementing effective configuration and change control procedures for SharePoint-based systems

Date and Time:

• Second Session: Tuesday, April 26th 2011 11:00AM-12:00PM EDT Registration

May 9th & 23rd 2011 –11am-12pm EDT – Implementing an Integrated Approach to Quality Management using SharePoint

Presented by Jeff Shuran, Product Manager, Montrium, Inc.

Webinar Overview:

Historically, life sciences companies have had to manage their quality processes using various applications in order to manager processes like Deviations, CAPA, Change Control, Document Management, etc. This has resulted in a higher cost of ownership in terms of maintaining these various applications, the training required for end users, and the integration that is required in order for all of these disparate systems to talk with each other. This webinar will discuss how an integrated approach can overcome these issues and bring a holistic approach to quality management through the use of collaborative technologies such as SharePoint. By taking an integrated approach, companies can leverage data as an asset and thus predict outcomes better which results in a proactive rather than reactive approach to quality.

Among the topics included will be:

• Integrating the quality systems elements.
• How quality systems should be positioned at the center of your processes.
• How information can be leveraged to make business intelligence decisions.
• Practical demonstration of how this can be achieved through SharePoint 2010

Date and Time:

• First Session: Monday, May 9th 2011 11:00AM-12:00PM EDT Registration
• Second Session: Monday, May 23rd 2011 11:00AM-12:00PM EDT Registration

June 6th & 20th 2011 –11am-12pm EDT – Leveraging your eTMF Documents to Automate Clinical Processes using SharePoint

Presented by Frédéric Landry, Director of Business Analytics and Operations, Montrium Inc.

Webinar Overview:

The eTMF is a goldmine of information that, if properly structured and exploited, can help drive processes and improve control and productivity. This session will illustrate some of the primary concepts behind leveraging eTMF documents to automate clinical processes using SharePoint and associated technologies. You will see how standard documentation structures and taxonomies once comprehensively linked with their governing processes can be exploited through SharePoint to enable state of the art Documentation Management, Business Process Management (BPM) and Business Intelligence (BI) solutions. During the session, a demonstration of Montrium’s Clinical Management Workspace will be given to further illustrate how these concepts can be applied.

Among the topics included will be:

• Transitioning to an efficient Clinical Process Management System
• Building Clinical Management standards as a foundation for growth, agility and performance
• Critical aspects of an eTMF and its actionable counterpart: the File Plan
• Defining business process maps, metrics and associated PKIs, an iterative approach
• A practical example illustrating the use of SharePoint as an eTMF and Clinical Process Management System
• Key functionalities for a successful Clinical Process Management System

Date and Time:

• First Session: June 6th 2011 11:00AM-12:00PM EDT Registration
• Second Session: June 20th 2011 11:00AM-12:00PM EDT Registration

July 11th & 25th 2011 –11am-12pm EDT – Integrating System and Change Management for Regulated Life Sciences Applications using SharePoint

Presented by Michael Zwetkow, VP Operations, Montrium Inc.

Webinar Overview:

When deploying IT solutions used to support GxP processes, initial successful validation is the first challenge, but maintaining a validated state during operation and maintenance is just as important and challenging. During this session we will see how SharePoint can be configured to help manage the changes made to validated systems in order to maintain control and ensure the system remains in a validated state. A live demonstration of how SharePoint can be used to dynamically manage validated state of computer systems and their sub-systems through the use of workflows and metrics will be given during the webinar. We will further discuss the importance of traceability not only within systems but also across systems so as to facilitate and automate impact assessment.

Among the topics included will be:

• Defining and structuring your GxP system landscape in SharePoint
• Integrating and automating change control
• Development of standard content including requirements, risk assessment and test scripts for cross system functionality
• Creation of dashboards and KPIs which provide high level information regarding overall validation status

Date and Time:

• First Session: July 11th 2011 11:00AM-12:00PM EDT Registration
• Second Session: July 25th 2011 11:00AM-12:00PM EDT Registration

June 18th 2010 – 11am-12pm EST – Going Paperless – Executing Validation of GxP Systems Electronically using SharePoint

Presented by Gianna De Rubertis, GxP Systems Validation Coordinator, Montrium Inc.

With the emergence of enterprise technologies and content management systems such as SharePoint, the documentation burden associated with paper-based validation can be greatly alleviated and even eliminated.  In this session, you will take a glimpse at the future of validation of GxP systems.  During this webinar, we will discuss the benefits, challenges and risks associated with going paperless.  You will see how SharePoint can be used to automate validation projects through the use of electronic documents and templates, electronic workflows, and electronic signatures.

Among the topics included will be:

• Using integrated workspaces in SharePoint to manage validation documents
• Using workflows to manage validation document lifecycle and test execution
• Maintaining the validated state: Integration with change control and configuration management
• Automating traceability through the use of standards
• Leveraging business intelligence dashboards to manage validation projects

This webinar was presented on June 18th 2010 by Gianna De Rubertis
Click here to download a copy of the slides.
if you would like to be informed of future webinar events hosted by Montrium.

June 4th 2010 –11am-12pm EST – Managing and Maintaining the Validated State of GxP Applications Using SharePoint

Presented by Michael Zwetkow, Pharmaceutical IT Project Leader, Montrium Inc.

When deploying IT solutions used to support GxP processes, initial successful validation is the first challenge, but maintaining a validated state during operation and maintenance is just as important and challenging. During this session we will see how SharePoint can be configured to help manage the changes made to validated systems in order to maintain control and ensure the system remains in a validated state. A live demonstration of how SharePoint can be used to dynamically manage validated state of computer systems and their sub-systems through the use of workflows and metrics will be given during the webinar. We will further discuss the importance of traceability not only within systems but also across systems so as to facilitate and automate impact assessment.

Among the topics included will be:

• Defining and structuring your GxP system landscape in SharePoint
• Integrating and automating change control
• Development of standard content including requirements, risk assessment and test scripts for cross system functionality
• Creation of dashboards and KPIs which provide high level information regarding overall validation status

This webinar was presented on June 4th 2010 by Michael Zwetkow
Click here to download a copy of the slides.
if you would like to be informed of future webinar events hosted by Montrium.

May 21st 2010 –11am-12pm EST - Beyond Automation: Extracting Actionable Intelligence from SharePoint

Presented by Frédéric Landry, Pharmaceutical IT Consultant, Montrium Inc.

This session illustrates the role of SharePoint as part of an integrated GxP solution that goes beyond automating existing processes. You’ll see how GxP operational components can be organized and connected to act as a Business Intelligence (BI) and Business Process Management (BPM) solution that integrates people, platforms and processes and delivers actionable intelligence back to the organization. You will leave with a strong understanding of the structures and standards that need to be put in place to ensure that your software investment makes your organization more effective as well as more efficient.

Among the topics included will be:

• Setting the foundation of business process maps
• Understanding how to identify metrics and KPIs within your organization
• Importance of establishing cross functional standards
• BPM and BI capabilities of SharePoint and how to exploit them
• Integration of data sources
• Example: Application of SharePoint BPM and BI tools for clinical trials management

This webinar was presented on May 21st 2010 by Frédéric Landry
Click here to download a copy of the slides.
if you would like to be informed of future webinar events hosted by Montrium.

May 7th 2010 –11am-12pm EST – Effective Configuration Control Techniques for Regulated SharePoint environments

Presented by Tevin Pathareddy, Pharmaceutical IT Project Leader, Montrium Inc.

SharePoint can become a victim of its own success as you deploy the platform across the enterprise. Within the context of a regulated environment it is imperative to maintain proper configuration control over your validated SharePoint environment. This can represent a significant challenge given the granularity and the large scope of SharePoint, particularly when using this platform as a document and records management solution. During this webinar, we will discuss the various elements of the system that must be managed under configuration control as well techniques and tools that can be used to facilitate this requirement.

Among the topics included will be:

• Implementation of formal system specific configuration control procedures
• Importance of defining clear taxonomies and standards across the enterprise
• Configuration deployment and version control techniques
• Integration with the validation and change control process
• Importance of leveraging a risk based approach to QC
• Using SharePoint to manage configuration control

This webinar was presented on May 7th 2010 by Paul Fenton
Click here to download a copy of the slides.
if you would like to be informed of future webinar events hosted by Montrium.

April 23rd 2010 –1pm-2pm EST - SharePoint and 21 CFR Part 11 – A risk based approach to validation for regulated environments

Presented by Paul Fenton, VP Pharmaceutical Processes and Technology, Montrium Inc.

When used as a system for managing regulated content and processes, SharePoint is subject to the requirements of 21 CFR Part 11 and related requirements. During this session we will review the approaches being taken by companies to validate their SharePoint environments, and emerge with a set of guidelines for a risk-based validation strategy for SharePoint. You will gain a clear understanding of why, when and how to validate SharePoint, and there will be a strong focus on reducing the time, cost and resources required to validate a SharePoint environment whilst providing maximum quality, control and ROI.

Among the topics included will be:

• Managing and validating a mixed SharePoint environment that includes both controlled and non-controlled SharePoint sites
• Risk evaluation methods for SharePoint systems
• A Step by Step overview of the risk-based validation process following the GAMP5 model
• Implementing effective configuration and change control procedures for SharePoint-based systems

This webinar was presented on April 23rd 2010 by Paul Fenton
Click here to download a copy of the slides.
if you would like to be informed of future webinar events hosted by Montrium.