Accurate  Consistent  Compliant Contact: i4i the structured content company the structured content company

i4i Inc. © 2016 i4i, an industry leader in the development of structured authoring technology for Microsoft ® Word since 1993, continues to innovate and evolve producing new generations of its XML authoring solution. An Industry Leader with a Unique Solution The intelligent structured authoring process is complemented by a simple and flexible repurposing function that enables output for any requirement – print, web, e-books, XML, etc. Preserving the complete Word authoring experience, users can work with the full feature set of Word while authoring in a fully functional structured content authoring environment. Innovative

i4i Inc. © years developing XML technology platforms 10 + years creating solutions for the Life Sciences industry Global Labelling Structured Product Labelling Regulated and Corporate Content SPLXEVMPDIDMP Embracing regulated standards & providing the right solution Experience & Expertise

i4i Inc. © 2016 An Industry Leader with a Unique Solution For over 10 years i4i has put its technical & regulatory expertise to work for the Life Sciences industry Take a Tour of Our Solutions Using familiar interfaces, ensuring widespread user adoption – no technical expertise required. Making authoring and managing structured content easy for everyone. Experience & Expertise

i4i Inc. © 2016 A Comprehensive Solution

i4i Inc. © 2016 Structured Content Authoring A fully validated solution, available as a standalone Authoring Solution or as an Enterprise Solution and can easily be integrated with most existing corporate content management systems. With a global labelling solution designed for the Life Sciences industry, x4o delivers structured authored applications with all of the functionality, flexibility, and extensibility of XML – all through the existing versions of Microsoft Word sitting on users’ desktops. All XML is hidden from the users. They use only the tool they know – Word. DESKTOP

i4i Inc. © 2016 Structured Content Authoring & Lifecycle Management Our Life Sciences Enterprise Solution expands our intelligent structured authoring tool with a robust suite of content creation, collaboration, and management features for all your labelling and corporate document needs. Designed specifically for the management of structured content. It provides full workflow, collaboration, and version control, using access control rules based on users, groups, roles, and permissions. A fully validated solution that easily fits within your corporate technology environment. ENTERPRISE

your challenges: time to market in competitive industry & compliance with regulatory agencies the XML advantage: Reuse : XML provides an easy way to create content once and reuse it in multiple documents and submissions. Reduces duplicate information, saves time and money while creating content that is accurate and up to date Repurpose : XML allows you to store one source of content and data and publish it in different output formats. Ensures consistency and efficiency Structure & Standard : XML supports industry–specific data structures, easing compliance with regulatory requirements and information exchange standards XML is a non-proprietary standard which guarantees longevity of documents Discovery : XML documents are metadata-rich for discovery and analysis WHY XML – WHY STRUCTURED AUTHORING i4i Inc. © 2016

Work in Microsoft ® Word No XML to learn Structure, Standardization & Efficiency Validation rules to enforce authoring standards Repurpose content by publishing to multiple formats [web, pdf, word, artwork…] and multiple outputs [USPI, MedGuide, brief summary, patient information…] Structured documents for all divisions in an organisation, e.g. – CCDS, CMC, US SPL, QRD, QUALITY, POLICY, PROCEDURE, LEGAL… Comply with the demands of regulatory agencies to meet quality and safety requirements during submission process Publish compliant regulatory submissions Metadata-rich for data discovery Intelligent Authoring i4i Inc. © 2016

AUTHORING FEATURES Intelligent Authoring NO TAGS NO XML TO LEARN Full Microsoft Word Experience +

i4i Inc. © 2016 Intelligent Authoring Correct Typography: Utility to enforce style guide requirements for your documents, ensuring consistency Unique Features Glossary Manager: Allows users to tag terms throughout documents and add definitions in a Defined Terms section of a document – terms are automatically added to the glossary table Taxonomy: Associate taxonomy terms with a selection of text

Authoring and Lifecycle Collaborative Environment Intelligent Content Management Regulatory Compliance Corporate Standards Reuse Repurpose Analysis & Discovery Designed specifically for XML-aware content, ALiCE extends x4o from the desktop into a powerful lifecycle management enterprise solution for all your product information, labelling, and corporate content. A fully validated solution that easily fits within your corporate technology environment. i4i Inc. © 2016

Intelligent Content Management FEATURES Full lifecycle management Dashboards for Process Management: Familiar, intuitive, browser interfaceCollaboration Access controlCCDS XML-aware for rich metadata content discovery Variants Version control and change request management Translations Publishing and submission management Relations Internal messaging and notification systemIDMP Audit control, reports, impact analysis Comprehensive validation Relations tracking Discussion panels/message boards

ADVANCED Content reuse Collaboration Translation management Artwork Integration Content tracking Document relations Impact analysis Compliance monitoring Integrated messaging Alert management Features i4i Inc. © 2016 BASICS Check in/out Versioning Audit trail E-signature 21 CFR Part 11 Workflow

DASHBOARDS FOR PROCESS MANAGEMENT Collaboration Translation IDMP Relations Variants CCDS Process Management i4i Inc. © 2016

Our Global Content Solutions Intelligent Authoring & Lifecycle Management of Regulated Content US SPL CCDS IDMP i4i Inc. © 2016 QUALITY & CLINICAL POLICY & PROCEDURE EU QRD POWERED BY:

Accurate  Consistent  Compliant The i4i Advantage Innovations in structured content. i4i Inc. © 2016

Analysis & Assessment Installation Migration Deployment Training Online, & Telephone Support Solution Implementation Process Implementation Process i4i’s i4i Inc. © 2016

Regulatory Services ● Creation & Migration Services ● Fast & Efficient ● 100% Validation Guarantee ● Electronic Submission Service [US] Support Services Thought, Technology & Industry Leadership ● Superior Support Services ● Technical & Regulatory Expertise ● Online Tracking Service ● View Announcements : regulatory guidance, product hints/tips, new releases ● Our investment in R & D ensures that we will continue to serve you as technology and regulatory requirements change ● i4i regularly participates and are key members on industry working groups and panels Experience & Expertise

WE’RE HERE TO HELP submission discovery process intelligent information product information XML harmony collaborate accuracy review regulated technology standards reuse publish solution structured consistency innovation organisation strategy content translation repurpose global labelling compliant metadata expertise HL7 SPL i4i Inc. © 2016

Contact: i4i Inc. © 2016 i4i the structured content company the structured content company