QUALITY DOCUMENT MANAGER

OBJECTIVE Quality Document Manager enables companies to define and manage a robust quality documentation process with enterprise-wide training, collaboration, and flexible electronic change control to enforce compliance in accordance with global standards.

OVERVIEWRegulated companies live and die at the hand of being first to bring the “best in class” product to the market rapidly without jeopardizing regulatory compliance. They must ultimately achieve a mature product development process coupled with a low compliance burden. Quality Document Manager helps companies make training and control document management part of the culture that permeates the organization—enabling consistent development and production of high-quality Medical Device products that will meet or exceed regulatory requirements.

Quality Document Manager automates and effectively manages enterprise wide control document and training processes. It can greatly simplify the document change and revision process and more importantly, reduce risk associated with the use of erroneous and outdated procedures.

Quality Document Manager manages control document revisions, approvals, training, and periodic reviews. Proposed changes are evaluated, justifications are documented and change plans are mapped out. Tasks are defined for reviews and approvals. Training can be assigned and tracked. Approved changes are released and implemented across operations. Quality Document Manager allows cross-functional teams to collaborate, capture, and approve the control document changes and implementations. Lifecycle tools can be used to ensure a consistent implementation of the approved effectivity and periodic reviews can ensure on going compliance.

Quality Document Manager helps to ensure and record that all effected staff are aware and trained to utilize new or revised control documents. For each new or revised item released, the system automatically sends notifications to personnel who are affected by that control document. The automatic training process engages staff for acknowledgement when documents are approved, and requires electronic signatures to verify they have performed any related mandatory training tasks.

Quality Document Manager automates good workflow management practices and promotes accelerated time to market. Medical Device companies can launch their products to market faster by enabling the entire development team to execute and communicate their tasks more efficiently.

• Lower costs and streamline operations from change orders through release approval, dissemination, and training.• Easily search documents and training requirements• Secure access to current and accurate documents at all times• Organize/sort using template and filtering tools • Coordinate and control training implemented across

multiple business groups, entities or locations• Reduce errors and cycle times with automated revision

management• A consistent, compliant closed-loop method to process

any type of change• Automated review process and approval routings• Notification of new or changed documents based on

affected roles• Eliminate wrong document use with built-in automated

training• Notification/Acknowledgment process

• Maintain compliance• Meet regulatory/legal/safety requirements with a fully

compliant automated training process and document management

• Easily prove training compliance with an auditable training program

Key Benefits:• Complete end-to-end control

document management• Dynamic links to related documents and data

for improved up-to-date visibility.• Templates to promote standards• Periodic review management for continuing

suitability and compliance• Enterprise change management to drive

change standards and consistency across the global enterprise

• Defined training processes with clear views of training status

• Full traceability and auditable document revision control

• Support for Electronic Signature - CFR 21 Part 11

HIGHLIGHTSKey features and capabilities include:

Complete Regulatory ComplianceQuality Document Manager easily enforces training compliance with an auditable training program and enforces control document management with a well-documented standardized change control process across all departments’— one centralized system.

• 21 CFR 820 Quality System Regulation (GMP—Good Manufacturing Process)

• 21 CFR 11 (ERES—Electronic Records and Electronic Signatures)

• ISO 13485 –(Clause 4) Establishment of a Quality management system

End-to-End Document and Training Management Quality Document Manager consolidates information and brings robust security controls to the forefront, helping to ensure that the right people have access to the right information at the right time. Seamlessly pairing control document management with training engages staff for acknowledgement when documents are approved or revised, and requires their electronic signature to verify that the related training has been completed. From a change control perspective, whether change involves proposed changes or unplanned changes, dynamic links enable related documents and data for improved up-to-date visibility into related business processes.

Quality Document Manager is used to control change to affected documents from beginning to end. To help ensure that all changes meet current compliance requirements, all document changes are tracked from the point the change is created to the time it is implemented internally or globally. Quality Document Manager captures basic information such as the summary, reason, and justification for change. Users are also able to perform where use analysis and impact assessments. Summary and History reports are provided to improve change status visibility and help identify process bottlenecks. By automating routing and approval and incorporating escalation for overdue tasks, document cycle times can be significantly reduced and sustain compliance by simplifying and streamlining the processes.

As changes are implemented, it is vitally important to publish these changes across the enterprise and develop updated training programs for users. In most Medical Device companies, the training coordinator usually physically informs trainees about their tasks. Hybrid or paper-based medical training systems are equally as inefficient in that they don’t provide the Medical Device companies with a uniform, intuitive means of conducting trainings. Quality Document Manager solves these training dilemmas by notifying trainers and trainees automatically upon completion of assigned tasks. In addition, trainees have access to their training records with a personalized view that shows past training, course due dates, and update their status.

Process Standardization with Template CreationQuality Document Manager can securely automate routing, escalation, approval, and delivery of SOPs, policies, and other documentation by providing the user the ability to create clearly defined templates. Template creation allows users to start standardizing documentation by providing a convenient starting point for document management using corporate standards.

Mapping precisely to your real-world operations, template creation is the start of an electronic workflow of tasks, assignments, alerts, escalations, and reviews that can be automated to the level you prefer for enterprise document change and training management. The system automatically maintains a fully compliant, detailed electronic archive of all templates.

Quality Document Manager supports a central repository that gives users the ability to access the right templates, at the right time. Administrators define document and training templates to enforce company/organization standards.

Streamline Workflow Quality Document Manager provides a centralized control of the process with integrated collaboration, review and approvals from designated subject matter experts. Feedback on the effectiveness of proposed changes and change plans requested are tracked and monitored, helping to ensure that changes are properly planned and will deliver the expected results— before they are rolled out across operations.

Tracking Documents and Training Management Quality Document Manager establishes an orderly and effective procedure for tracking documents and training management. “My Documents” allows users to quickly view their personal view of documents, create documents, templates, and periodic reviews and implementations of the user. In addition, users can enact document-filtering, release a document, define the responsible organization, define the subject matter expert, define the implementation organization and responsible person, and /or raise a change order against a document. Quality Document Manager training solution helps to ensure and record that all affected staff are aware and trained to utilize new or revised documents.

Collaboration & ApprovalsUsers can benefit from a wide range of capabilities for global enterprise collaboration. Those capabilities include the ability to manage and organize shared documents and structured product data. They also enable the creation of digital workspaces for virtual teams to work together. Users can easily raise issues, organize meetings and track decisions while any object lifecycle modifications can be formally approved using routes defined by end-users or, to simplify and facilitate a repeatable approval process, standard route templates.

Microsoft IntegrationUsers can create and access 3DEXPERIENCE® data from the most popular Microsoft applications: Word®, Excel®, PowerPoint®, Outlook®, Windows Explorer, and Windows Desktop Search. This capability enables enterprise-level collaboration while not disrupting the established productivity of end-users. With product content being managed in 3DEXPERIENCE rather than on users’ PCs, organizations are able to create, manage and review product content more securely.

Our 3DEXPERIENCE® platform powers our brand applications, serving 12 industries, and provides a rich portfolio of industry solution experiences. Dassault Systèmes, the 3DEXPERIENCE® Company, provides business and people with virtual universes to imagine sustainable innovations. Its world-leading solutions transform the way products are designed, produced, and supported. Dassault Systèmes’ collaborative solutions foster social innovation, expanding possibilities for the virtual world to improve the real world. The group brings value to over 190,000 customers of all sizes in all industries in more than 140 countries. For more information, visit www.3ds.com.

Europe/Middle East/AfricaDassault Systèmes10, rue Marcel DassaultCS 4050178946 Vélizy-Villacoublay CedexFrance

AmericasDassault Systèmes175 Wyman StreetWaltham, Massachusetts02451-1223USA

Asia-PacificDassault Systèmes K.K.ThinkPark Tower2-1-1 Osaki, Shinagawa-ku,Tokyo 141-6020Japan

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