MasterControl Software Solutions Overview

While market globalization has vastly increased the profit potential for manufacturers and other businesses, it has also intensified competition and the pressure to produce faster and at a lower cost. The situation is doubly challenging in a regulated environment (FDA, EMEA, etc.), where companies must contend not only with cutthroat competition, but also stringent regulatory requirements. How Can MasterControl Software Solutions Help You? With more than a decade of experience in rigorous regulatory environments, MasterControl has developed integrated software solutions that combine industry best practices with the flexibility to meet every customers unique needs. These solutions include: Quality Management The MasterControl quality management suite consists of configurable, easy-to-use, and connected applications for automating, streamlining, and effectively managing document control, change control, training control, audits, corrective/preventive action (CAPA), customer complaints, and other documents- and formsbased quality and business processes under a single Web-based platform. Hundreds of companies worldwide rely on MasterControl to facilitate compliance with global regulations. Document Management The MasterControl Documents document management solution provides secure and sophisticated storage, versioning, metadata, security, retrieval, and indexing functionality. Initially released in 1998, MasterControl Documents has developed into a comprehensive, market-leading document management software system that improves efficiency and productivity throughout the enterprise. MasterControl automates and accelerates the processes of changing, approving, notifying, and routing documents, which significantly reduces the time it takes to bring new products to market. Product Lifecycle Management The MasterControl TotalMFG system package helps regulated or discrete manufacturers of all varieties to get products to market faster by streamlining collaboration on critical documents and accelerating all processes involving the lifecycle of a product. MasterControls product lifecycle management system is both a central and secure repository for all documentation affecting a product as well as an efficient, automated collaboration tool for all teams involved in production on any level. Audit Management MasterControl audit management solutions help companies with a variety of internal and external audits including regulatory, laboratory, clinical, and quality audits. This enables companies to deploy a single, flexible solution for ensuring quality and compliance across the enterprise. It is cost-effective, easy-to-learn and use, and supported by IT departments and corporate management because it completely meets their needs. Training Management MasterControl Training automates assignment and monitoring of training tasks and grading of online exams to ensure competency and compliance across the enterprise. It allows sequencing of training courses, so after a prerequisite course is completed the next one is automatically launched. It provides a group sign-off feature for verifying training of large groups of employees. Training control can be seamlessly integrated with the rest of the quality system, so any change to a document or process that warrants new training will automatically invoke training tasks upon approval of the change. Bill of Materials (BOM) Management MasterControl Bill of Materials helps each manufacturing company simplify and standardize BOM management across all departments. Its a flexible system that controls multiple iterations of a BOM generated
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MasterControl Software Solutions Overview

during the design process and enables users to exchange BOM data with suppliers or other external entities. MasterControl BOM insures that all departments have an accurate, updated view of the revision levels of every component in their particular configurations. Documents defining the components are easily viewed directly from the BOM, ensuring that the right documents and revisions are used in the manufacturing process. Supplier Management MasterControl Supplier automatically manages supplier statuses and quality information (such as nonconforming material reports) all within a single, easy to access location. In addition to providing an easily maintainable Approved Vendor List (AVL), MasterControl Supplier features a user-friendly interface for accessing all documentation and records related to each supplier. Submissions Management MasterControl submissions management tools facilitate electronic delivery of FDA applications (such as INDs, NDAs, BLAs, etc.) by providing control in assembling and tracking necessary documentation. MasterControls Submissions Gateway provides appropriate templates to streamline the dossier-creation process. MasterControl accelerates the development of submissions by integrating with leading e-submission applications in order to connect approved documents and forms-based content with the dossier assembly process.

MasterControl Services MasterControl is dedicated to continuous process improvement, developing innovative software and providing unsurpassed customer service. MasterControls Services Consultants assist with the installation and configuration of MasterControl products and perform business process assessments, troubleshooting, migration and software upgrading as necessary. GxP Business Process Services Understanding every step of an organizations GxP and other business processes is crucial. This is especially relevant when transitioning from a manual system to one that is streamlined and automated. MasterControl GxP and Business Process Services ensure that processes automated with MasterControl solutions are defined and delivered to address every user requirement. To this end, MasterControl provides services for Process Consulting and Process Implementation to help customers achieve desired results. Nothing less can be expectedbecause if the customer is not successful, MasterControl is not successful. Process Consulting This service focuses on investigating requirements for a GxP or business process and then creating a design based on best practices, which includes the form(s) and other elements necessary to enable the defined process. The deliverable of this service is a design document that provides clear specifications necessary for the successful implementation of a process by either the customer or a MasterControl Service Professional. This may require on-site service for requirements gathering. Process Implementation This service is designed to provide assistance with creating, implementing, changing, or testing a GxP or business process where the requirements have been defined. Testing includes ensuring that a form is operational on a supported MasterControl ProcessTM software release. This service may include the tailoring of complex processes using automation, JavaScript, and advanced process creation techniques and methods. Also available to customers is assistance with the creation of process outputs: custom views of aggregate data, ad-hoc reports, trending, rules-based reports, and scheduled reports using the MasterControl AnalyticsTM module. This service can be provided either remotely or onsite depending on customer needs and requirements.

MasterControl Software

Education Services MasterControl provides a variety of educational services to help users become familiar with the software and improve productivity. Whether customer needs focus on enabling a new system or building a stronger understanding of a current system, the Education Center is ready and anxious to assist. MasterControl offers a rich variety of live and recorded instructional materials and courses designed to help both users and administrators get the most from MasterControls products and services. Best practice guidelines taught by professionals with years of experience provide customers with the knowledge necessary to implement and use MasterControl throughout the enterprise, thereby making every department more effective and efficient. Integration Services In addition to using MasterControl software to automate internal processes, companies frequently deploy a variety of other third-party software applications. Examples may include enterprise resource planning (ERP), customer resource management (CRM), manufacturing execution systems (MES), and product data management (PDM) applications. MasterControl integrates well with many major software applications typically used by companies. In some cases there are many connection points between MasterControls system functionality and the functionality of other applications. When properly configured, these connection points can vastly improve a companys overall performance and automation. MasterControls Connections Toolkit enables companies to bridge that functionality by integrating MasterControl with third party systems. Project Management Services MasterControl offers project management services to help alleviate the challenges of project management and ensure successful implementation of any MasterControl product. Through this service, MasterControl will provide the continuity and quality that customers need during the deployment process. An experienced MasterControl Project Manager will provide management expertise, serve as a project champion, coordinate activities, and communicate critical milestones. This provides a single point of accountability and communication for the entire project. Technical Support MasterControls Technical Support Department answers questions and provides solutions to problems customers may have with the software. MasterControl maintains several levels of support, ranging from online self-help to in-person assistance. All these options are put in place to provide greater customer satisfaction. Validation Services MasterControl considers validation an integral part of software solutions for FDA-regulated customers. MasterControls unique continuous validation approach dramatically cuts the time, pain, and cost involved in validation, making it easier to re-validate future upgrades. MasterControls continuum of products and services address different levels of validation needs based on individual risk assessment. MasterControls validation products and services include: MasterControl Transfer OQ Based on a companys corporate policy and risk assessment, it may choose to assimilate or transfer OQ documentation as part of its overall validation effort, saving both time and money. TOQ provides completed validation and support documentation of IQ/OQ tests performed at MasterControl. MasterControl Validation Execution Services To improve the speed and productivity of a companys execution of the validation process, MasterControl services includes the IQ/OQ Validation Execution Service, which is completed at the customers site and assisted by MasterControl experts. This ensures that the customers system is appropriately tested and verified to meet the design functionality.

Solutions Overview

MasterControl PQ Validation Execution Services Based on usage, policies, and procedures, MasterControl creates a custom PQ protocol to meet the clients protocol. In addition, onsite assistance ensures the timely execution of the customers protocol. MasterControl GxP Documentation This service provides documentation activities throughout the lifecycle of a project as it pertains to FDA requirements. This includes activities from the projects validation planning stage through its final reporting and acceptance of the system. Some of the deliverables include the Validation Plan, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), and Risk Management Plan. In addition, customers can expect testing summary reports concerning their IQ, OQ, PQ and validation activities, as well as a final report for the overall validation project.

About MasterControl Inc.

MasterControl produces software solutions that enable regulated companies to get their products to market faster, while reducing overall costs and increasing internal efficiency. MasterControl securely manages a companys critical information throughout the entire product lifecycle. Our software is known for being easy to implement, easy to validate and easy to use. MasterControl QMS and QEM solutions include quality management, document management/document control, product lifecycle management, audit management, training management, bill of materials, supplier management, submissions management, and more. Supported by a comprehensive array of services based on industry best practices, MasterControl provides our customers with a complete information management solution across the entire enterprise. For more information about MasterControl, visit www.mastercontrol.com, or call: 1.800.825.9117 (U.S.); +44 (0) 1256 325 949 (Europe); or +81 (03) 6801 6147 (Japan)

MasterControl Inc.
Corporate Headquarters:
MasterControl Inc. 6322 S. 3000 E. Ste. 110 Salt Lake City, UT 84121 United States Phone: 800.825.9117 Fax: 801.942.7088 www.mastercontrol.com

European Headquarters:
MasterControl Global Limited First Floor North Wing Matrix House Basing View Basingstoke RG21 4FF United Kingdom Phone: +44 (0) 1256 325 949 Fax: +44 (0) 1256 325 289 www.mastercontrolglobal.co.uk

Asian Headquarters:
MasterControl KK Aios Akihabara 702 3-2-2 Ueno Taito-ku Tokyo 110-0005 Japan Phone: +81 (3) 6801 6147 Fax: +81 (3) 6801 6148 www.mastercontrol.co.jp Email: info@mastercontrol.com

Mendelstrasse 11 48149 Muenster Germany Phone: +49 (0) 251 980 2140 Fax: +49 (0) 251 980 2149 www.mastercontrol-global.de

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MasterControl Software Solutions Overview