Global Labeling Division

Business Process Change: Migrating from MS-Word to XML to meet Board of Health Requirements and Business Process Needs Bernie Coney Global Labeling Division Wyeth Pharmaceuticals July 11, 2007 Agenda  Background for the changes related to FDA requirements for Structured Product Labels (SPL)  Wyeth’s approach in addressing the transition to xml and compliance with SPL  User experience and strategies for successful implementation of xml-authoring in the Labeling group Confidential 2 FDA Regulation for SPL  October 31, 2005 FDA issued regulation for electronic labeling to be submitted in Structured Product Labeling (SPL), xml format  Labeling group creates U.S. labeling documents for Wyeth Pharmaceuticals for submission to FDA  Industry prior to xml, labeling was submitted in MS-Word and PDF formats Confidential 3 MS-Word Labeling  Labeling group Created 6 versions of the US label for Submission to FDA – Manual track-changes using MS-Word formatting to create strike-through and double-underline markings to represent added and deleted labeling text – Versions were created in Document Management system through copying and pasting documents – PDF’s were created of 3 final MS Word documents Confidential 4 MS-Word Process Technical Editing and Proofreading activities Confidential 5 Staff at the Time of Implementation  Labeling group comprised of content authors and technical support staff – Staff had no experience with xml prior to implementation of SPL – Labeling documents were created in MS Word for all regions  Skills required for the new roles reflected technology/process challenges that may not match up with current skill levels or requirements. The options included: – Training internal people to meet the new requirements – Evaluating the roles and skills currently within Labeling – Opportunities to develop internal expertise to support Wyeth Confidential 6 Initial SPL Conversion  Purchased Software package to create SPL – Implementation included xslt stylesheets to create labeling documents in MS Word from xml – Production began with compliance, select users trained as Super Users to support 30 users of software  Initial SPL files were vendor-supported through data conversion from MS-Word to XML files – Implemented a Quality Control process for confirming the accuracy of the conversion – 4 FTE’s supported conversion process with 1 Manager Confidential 7 MS-Word Process + SPL SPL Data Conversion Technical Editing and Proofreading activities Confidential 8 Change Management     Labeling Managers content experts, not familiar with xml Proofreaders no prior experience with reading xml Document Specialist no experience editing xml xml files changed a 40 page MS Word document into 100’s pages of xml Confidential 9 New Requirements  SPL required labeling in xml format with additional pieces of the labeling converted to metadata – Narrative content remained the same – Formatting changed through the FDA stylesheet – Drug Product Information, and coding of sections in the labeling Confidential 10 Drug Listing Data Elements  Content from labeling in MS-Word now required to be additional metadata in the SPL file. – FDA provided terminology to express metadata for elements, such as active ingredient, inactive ingredient, packaging, and imprint information. – Active ingredient includes the name of the ingredient as well as an identifier and strength. Confidential 11 SPL Example – Data Elements  SPL file contains xml metadata with information about the product.  Strength of active ingredient, packaging information, etc.  Metadata viewable in FDA stylesheet Confidential 12 Additional metadata required by FDA  All sections of the labeling are pre-assigned a unique code by the FDA, using Logical Observation Identifiers Names and Codes (LOINC). See: http://www.fda.gov/oc/datacouncil/spl.html Confidential 13 Success Factors  Communication between the Labeling group and internal business units that require labeling – Conversion process introduced – Time-sensitive documents would require more time to complete conversion – Presented impact to personnel to Senior Management throughout the process Confidential 14 Success Factors  Structured Labeling Initiative formed in 2005 to address SPL and future requirement of Product Information Management (PIM) in European Union. – Cross-functional team of business units within Wyeth that are impacted by Labeling – SPL Pilot conducted in early 2005 through the Summer in preparation for deadline of October implementation by FDA  Teamwork: Labeling group delivered SPL files on-time for submission to FDA without any delays to planned submissions beginning October 31, 2005. Confidential 15 Transition to XML Authoring  User experience and strategies for successful implementation of xml-authoring within the Labeling group Confidential 16 Labeling Group  Looked for opportunity beyond the SPL & PIM requirements – Rendering to Word vs. Manual Track Changes – Content Management – Leading Wyeth into broader XML use  What challenges did we incur from current process? – Agree upon likely process changes – Align roles and resources to support process changes – Agree initial communication and migration plans for staff Confidential 17 Stepwise Approach  Business Unit partnered with IS colleagues, 3 month effort prior to validation of xml to MS-Word transformation – 7 preliminary rounds of pre-test data gathers – Character-per-character review of xml vs. output (initially Word and PDF); 7 documents – Data was shared with IS, and repairs made to the stylesheets after Meetings with Business Unit Confidential 18 Validation  We recognized rendering from the SPL schema is unlikely to produce labeling documents that meet all of our internal requirements – Authoring occurs in a “page-less” environment which means that page flow and Regulatory standards can’t be met until content is rendered. – Address any inaccuracies that are introduced in the rendition process  Limited the amount of stylesheets to MS-Word renditions, retiring the PDF stylesheets Confidential 19 Validation  Process allowed for a manual formatting of rendered MS-Word documents (and PDFs by extension) to: – Optimize appearance / behavior – Address any inaccuracies that are introduced in the rendition process Confidential 20 Process Support  Qualified an xml-Comparision software to support proofreading. – Proofreaders moved from reading xml and MS Word character-per-character to Diffing 2 versions of xml. – Document Specialists trained to support Content Authors on the XML Editor. – Document Specialists coordinated a refresher training session for Content Authors. – Created a database to capture user experience as the department migrated to xml-Authoring. Confidential 21 LM Draft Word V.1 E LM Draft Word V.3 Previous Word Environment Fully manual editing process • Annotations added/deleted manually • Manually simulate track change functions • Copy files to edit manually Labeling Repository TE Word V.1 A Word V.3 TC TC M Word TC C Word PR V PR V Render to PDF M PDF PR V KEY E - Editorial Read (optional) TC - Text Compare PR - Proofread V - Verification A PDF C PDF V V V Confidential 22 LM Draft SPL V.1 E LM Draft SPL V.3 XML Today • Automated creation of Word documents via style sheets • Additional QC due to conversion from Word to XML, and new stylesheet approach • Render in Document Management system Labeling Repository TE SPL V.1 TC (Diffdog) LM Draft SPL V.3 PR Render to Word from XML A Word TC M Word TC C Word PR V KEY E - Editorial Read (optional) TC - Text Compare PR - Proofread V - Verification PR V Render to PDF M PDF PR V C PDF A PDF V V V Confidential 23 LM Draft SPL V.1 E LM Draft SPL V.3 Future XML • Automated creation of Word documents via style sheets • Verification of outputs • Render in Document Management system Labeling Repository TE SPL V.1 TC (Diffdog) LM Draft SPL V.3 PR Render to Word from XML A Word M Word C Word V KEY E - Editorial Read (optional) TC - Text Compare PR - Proofread V - Verification V Render to PDF M PDF V C PDF A PDF V V V Confidential 24 XML Today - Rationale High Rationale • XML conversion Number of QC STEPS • Validation in June 2006 • Content/ format issues from SPL source to Word output Low Low High • New paradigm with Business Units dependent on labeling document Comfort Level Confidential 25 Success Factors  Document Specialist and Proofreaders had a lot of exposure to xml prior to validation of stylesheets: roles performed all the Q.C. of conversion files.  Content Authors began editing source content once in xml and creating necessary output via stylesheet.  Internal resources were used to support the department, which fostered greater collaboration and ownership of the software and process.  Pre-validation testing and collaboration of the Business Unit and IS led to smoother validation execution. Confidential 26 Summary  Initially limited the exposure of xml-authoring to Quality Control process.  Migrating authoring into xml via creating stylesheets to produce labeling documents, limiting the scope of validation to MS-Word to meet internal requirements  Refresher training sessions were held during first year of implementation  Departmental staff acted as help desk, created ownership of software and collaboration within the Labeling group Confidential 27 Questions? Bernie Coney coneyb@wyeth.com 484-865-3479 Confidential 28