Quality Management System Nov 12, 2013

Alfresco QMS QMS - Regulatory Solution Key Industries Pharmaceutical BioTech Manufacturing Regulatory Standards FDA 21 CFR 11 GxP compliant ISO 9001 QMS goal is to reduce and eventually eliminate nonconformance to Specifications, Standards, and Customer expectations

Solution Features - UI Alfresco QMS User Interface Native UI built on Alfresco Share Look and feel is same for both Regulatory and Non- Regulatory Documents Custom Views (Document List and Details Page) Modified Advance search including Saved Searches (site specific) Audit trail Workflow history of Document

User Interface – Document List View Alfresco QMS

User Interface – Custom Properties Alfresco QMS

User Interface – Document Details Alfresco QMS

Solution Features – Business Rules Configuration Alfresco QMS Configuration model Used Alfresco datalists where applicable Specific Config site to manage all configurations Configurations control the following: Document Types and Aspects applicable to the types Unique Document Id generation information Default groups for reviewers and approvers (one workflow can be used for different document types where needed) Value Assistance fields for property fields including dependency rules

User Interface – Configuration Alfresco QMS

Solution Features – Workflow Alfresco QMS Workflow Enhancements Out of Office feature on User profile. Tasks forwarded to identified delegatee automatically if needed (AD or in config site) Additional item(s) section for reference documents Custom user/group pickup list Default values driven from config site Escalations and notifications and options to select custom users/groups At end of every task or At the completion of the workflow

Workflow – Out of Office Alfresco QMS

Workflow – Initialization Default Values from Configuration Alfresco QMS Rules Driven Default Values

Workflow – Initialization Alfresco QMS Attachments Section Custom Metadata Notification Options

Workflow – Initialization Alfresco QMS Multiple Options for User Selection

Workflow – Announce Final Task Alfresco QMS Review and Approval History comments

Workflow – Document Announce Task Alfresco QMS Stamping Options

Solution Components - Summary Built up a compliance framework which provides: Digital / Electronic Signatures Audit Trails and Reporting Watermarks and Overlays Document Lifecycles and Security Auto-numbering PDF Renditions Controlled Printing Alfresco QMS

CONTACT INFORMATION Thank you for your time. For more information, please contact: Eswar Eluri Principal Vancouver 1190 Melville Street, Suite 512 Vancouver, BC V6E 3W1 Seattle 705 Second Avenue, Suite 505 Seattle, WA Office Locations: |