The views and opinions expressed in the following PowerPoint slides are

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1 Electronic Tools and Gadgets Julie P. Retzinger RN, MBA Baxter Healthcare The views and opinions expressed in the following PowerPoint slides are those of the individual id presenter and should not be attributed t to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. i All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. Drug Information Association 2 1

2 Electronic Tools and Gadgets: Presentation Outline Document Management System (DMS) Proof- reading tool CCDS issuance/distribution CCDS/label implementation tracking Drug Information Association 3 Authoring: Document Management and Control Benefits of a document management system (DMS) Electronic control of document Allows for control of production (authoring), storage and distribution of documents Elements to consider when establishing a DMS Compatibility with infrastructure within your organization Continue support to the DMS, internal and external Authoring capabilities Work flow capabilities Audit trail capabilities Drug Information Association 4 2

3 Authoring: Document Management and Control Establishment of an authoring template Establish standard headings for all key elements of the CCDS Establish header and footer standards Establish a unique numbering or identification system Establish font and style to use, consider readability (san serif) Method to communicate mandatory and non mandatory information Establish foot note standards Corporate trademark considerations Drug Information Association 5 Electronic Proof Reading Tools Consider an IT Proof Reading Tool the power of the human mind Aoccdrnig to a rscheearch at cmabrigde Uinervtisy, it deosn't mttaer in waht oredr the ltteers in a wrod are, the olny iprmoatnt tihng is taht the frist and lsat ltteer be in the rghit pclae. The rset can be a taotl mses and you can sitll raed it wouthit a porbelm. Tihs is bcuseae the huamn mnid deos not raed ervey lteter by istlef, but the wrod as a wlohe. Amzanig huh? Drug Information Association 6 3

4 Electronic Proof Reading Solution Vs Manual ACCURACY Accuracy remains constant over time TIME Drug Information Association 7 Electronic Proof Reading Tools Attributes to seek: Can check all changes between Word, PDF, XML, and text files, regardless of layout or format Can inspect text in all languages including Braille Detects missing, added, or moved text, as well as font differences or spelling errors Drug Information Association 8 4

5 Electronic Proof Reading Solution: Through the Life Cycle of the Label Regulatory Affairs & Legal Packaging Development Graphics Incoming Inspection Quality Control/Quality Assurance Text Inspection Artwork Inspection Print Inspection Barcode Verification + Braille Verification Issuance of CCDS Options for System Management: Document Management System (DMS) if on global server system (not as controlled) Web page system: link to controlled (DMS) Considerations for issuance Standard Cover letter Identifies any specific implementation activities for that particular CCDS Identifies the time frame allowed to implement into country specific labeling May carry links to web page or document management systems Give contact information for person responsible for issuance an implementation activities May link to other standard forms Deviation request form Deferral request form Drug Information Association

6 Benefits/Attributes/Functionality: Functionality Workflow management SOP and compliance enforcement Tracking item management Risk mitigation Audit Trail Reports Drug Information Association 11 The Value Add Centralizes data in a secure environment Supports harmonize labeling globally Decreases legal liability Measures and report on global labeling implementation Enforces internal standard operating procedures and processes Drug Information Association

7 Decisions (Concepts) Modifications to Core Data Sheet Local Labeling Health Authority Global Labeling Committee Drug Information Association 13 Tracking Item Unique Number Identifies one or more decisions EMA Centralized Procedure functionality Configurable country assignment features Timeline / Workflow The process from start to finish Factors that determine the duration of the timeline include Pi Priority it (e.g. Expedited, d Standard) d) Scope (Global or Local) Origin (e.g. Board, Committee, Health Authority) The timeline is configurable and is made up of key dates Provides historical view of timelines Drug Information Association

8 Milestones / Tracking Dates Individual dates associated with events Categories Milestones (e.g. Issued to Affiliate, Submitted to Health Authority) Informational (e.g. Date Source Country Labeling Sent) Pending (e.g. Health Authority Approval) KPIs The measureable duration between two dates Factors that determine e the duration between ee two dates may include Priority (e.g. Expedited, Standard) Scope (Global or Local) Origin (e.g. Board, Committee, Health Authority) Drug Information Association 15 Some Examples of KPIs: Completed On Time Completed Late In Progress On Time In Progress Late Drug Information Association