Implementing an Integrated Quality Management
System in SharePoint
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Implementing an Integrated Quality Management System in SharePoint
1. Implementing an Integrated Quality Management
System in SharePoint
Presented by Jeff Shuran
Director Global Sales & Marketing
January 19th, 2012
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. / 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
4. / Today’s Current Challenges for Quality
• Deficiencies in Control of Processes
• Deficiencies in the Accountability of People
• Deficiencies in the Visibility of Data
5. / 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
6. / 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
7. / 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
8. / 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
9. / 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
10. / 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
11. / 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
12. / 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
13. / 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
14. / 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
15. / 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
16. / 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
17. / 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
18. / Workspaces - Approach
Incident Management Training
Audits Validation Documentation
CAPA Change Management
Change Control SOP Management
Batch Records Supplier Quality
20. / 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)
21. / Next Webinar
Announcement Coming Soon
Montrium Webinar Series
22. / 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