Implementing an Integrated Quality Management System in SharePoint Presented by Jeff Shuran Director Global Sales & Marketing

January 19th, 2012

/ 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

• Quality Challenges in Life Sciences Today

• Benefits of an Integrated Approach to Quality

• How Quality Systems Should be Positioned at the Center of your Processes

• Why SharePoint?

• How information can be leveraged to make business decisions

• Examples of an Integrated Quality Management System

• Lessons Learned

• Upcoming Webinars

/ Today’s Current Challenges for Quality

• Deficiencies in Control of Processes

• Deficiencies in the Accountability of People

• Deficiencies in the Visibility of Data

/ Quality and Compliance Challenges

• Meet FDA/EMEA regulations that can only be solved with a centralized and holistic approach to quality

• Securely identify, track and manage many disparate processes

• Guarantee reliable and current information needed to make proper business decisions

• Proactively rather than reactively identify product issues and problems

/ Quality and Compliance Challenges

Regulatory Demands

– Avoid 483s, warning letters, and maintain consistent compliance (i.e. GxP , 21 CFR Part 11, other FDA/EMEA regulations)

– Alleviate and lessen the risk of stopping production

– Shorten process timelines by closing issues faster and more accurately

/ Case Study

Profile of the client

• Mid-sized pharmaceutical company headquartered in the Northeastern US

• Multiple facilities

• Contacted Montrium regarding implementing a Global Quality Management System

/ Case Study

The state of the environment from a quality perspective

• Quality not a main component of company culture

• Quality was an afterthought

Thus

• Quality was very decentralized

• Islands of data and processes existed

/ What is the most pragmatic approach to tackling all of these issues?

An Integrated Approach Allows for a Strategic Approach and Benefits

• Customer Service

• Regulatory Affairs

• Manufacturing

• Laboratory and Production

• Department Managers

• Assigned Parties

• Executives

/ Case Study

Identifying, tracking, and managing quality issues should involve an integrated approach that brings together the following entities:

• Manufacturing

• Research and Development

• Regulatory Affairs

• Quality Assurance

• Quality Control

• Drug Safety

• Other Areas

/ Power of Integration

• Accelerate the time for resolution and closure of issues

• Reduce the risk of missing records and data

• Spend time on value added activities instead of non-value activities

• Reduce the risk of error through entering in data multiple times

• Allows the ability to see across the enterprise and utilize this data for metrics and trending

/ Increase Visibility Across The Enterprise

• Increased visibility across the enterprise by alerting the proper users about what due dates are and escalating any late issues

• Increase responsiveness to issues that may arise

• Elimination of errors and repeat issues by centralizing quality processes

• Preclude product recalls

/ Increase Visibility Across The Enterprise

• Proactive approach can reduce the risk of repeating the same mistakes in the future

• Keep a positive brand image

• Reduce the legal risks

/ SharePoint’s Strategic Advantage

Consider the cost of licensing, support, training, and maintenance of various tools like

• Content Management Systems

• Document Management Systems

• Reporting Tools

• Collaboration Tools

/ SharePoint’s Strategic Advantage

Furthermore and perhaps more importantly, consider the cost of

• Users’ frustration over multiple tools

• Management not being able to get their arms around and extract organization information

• Relevant information is not available when needed

/ What is SharePoint?

“Microsoft SharePoint makes it easier for people to work together. Using SharePoint, your people can set up Web sites to share information with others, manage documents from start to finish, and publish reports to help everyone make better decisions”

- http://sharepoint.microsoft.com/en-us/Pages/default.aspx

/ Why SharePoint?

SharePoint’s Building Blocks

• Sites – Building and Managing Internal and External Websites

• Communities – Creating a Collaboration Environment

• Content – Manage Your Documents, Data, and Records

• Search – Leverage your Organization’s Data

• Insights – Mining for Business Intelligence

• Composites – No code solutions to rapidly respond to business needs

/ Workspaces - Approach

Incident Management

Audits

CAPA

Change Control

Batch Records

Training

Validation Documentation

Change Management

SOP Management

Supplier Quality

/ Quality Workspace Example

/ Lessons Learned

Integrated Quality System Based on SharePoint

• Increase in Quality and Compliance

• Centralized Quality Processes

• Manage and Meet External and Internal Regulatory Requirements

• Greater visibility into Issues

• Take a Proactive Approach Through Trending

• Lower Cost of Ownership (i.e. Validation, Upgrades, Integration)

/ Next Webinar

Announcement Coming Soon

Montrium Webinar Series

/ Contact Details

Jeff Shuran

Montrium Inc.

507 Place d’Armes, Suite 1050

Montreal (QC) H2Y 2W8

Canada

Tel. 514-223-9153 ext.219

jshuran@montrium.com

www.montrium.com