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 customer’s 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. MasterControl’s 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. It’s a flexible system that controls multiple iterations of a BOM generated

MasterControl Software Solutions Overview

ensuring that the right documents and revisions are used in the manufacturing process. Documents defining the components are easily viewed directly from the BOM. • 2 MasterControl Software . Testing includes ensuring that a form is operational on a supported MasterControl ProcessTM software release. MasterControl is not successful. • Supplier Management MasterControl Supplier™ automatically manages supplier statuses and quality information (such as nonconforming material reports) all within a single. Submissions Management MasterControl submissions management tools facilitate electronic delivery of FDA applications (such as INDs. updated view of the revision levels of every component in their particular configurations. This service may include the tailoring of complex processes using automation. MasterControl’s Submissions Gateway™ provides appropriate templates to streamline the dossier-creation process. developing innovative software and providing unsurpassed customer service. MasterControl Supplier features a user-friendly interface for accessing all documentation and records related to each supplier. To this end. implementing. • GxP Business Process Services Understanding every step of an organization’s GxP and other business processes is crucial. This is especially relevant when transitioning from a manual system to one that is streamlined and automated. • Process Consulting This service focuses on investigating requirements for a GxP or business process and then creating a design based on best practices. JavaScript. and scheduled reports using the MasterControl AnalyticsTM module. easy to access location. trending. Nothing less can be expected—because if the customer is not successful.) by providing control in assembling and tracking necessary documentation. Process Implementation This service is designed to provide assistance with creating. BLAs. In addition to providing an easily maintainable Approved Vendor List (AVL). MasterControl GxP and Business Process Services ensure that processes automated with MasterControl solutions are defined and delivered to address every user requirement. troubleshooting. • MasterControl Services MasterControl is dedicated to continuous process improvement. Also available to customers is assistance with the creation of process outputs: custom views of aggregate data.during the design process and enables users to exchange BOM data with suppliers or other external entities. which includes the form(s) and other elements necessary to enable the defined 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. ad-hoc reports. MasterControl BOM insures that all departments have an accurate. rules-based reports. and advanced process creation techniques and methods. This may require on-site service for requirements gathering. 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. changing. MasterControl’s Services Consultants assist with the installation and configuration of MasterControl products and perform business process assessments. This service can be provided either remotely or onsite depending on customer needs and requirements. migration and software upgrading as necessary. or testing a GxP or business process where the requirements have been defined. NDAs. MasterControl provides services for Process Consulting and Process Implementation to help customers achieve desired results. etc.

MasterControl offers a rich variety of live and recorded instructional materials and courses designed to help both users and administrators get the most from MasterControl’s products and services. Technical Support MasterControl’s Technical Support Department answers questions and provides solutions to problems customers may have with the software. and cost involved in validation. coordinate activities. MasterControl’s validation products and services include: • MasterControl Transfer OQ™ Based on a company’s corporate policy and risk assessment. Whether customer needs focus on enabling a new system or building a stronger understanding of a current system. MasterControl will provide the continuity and quality that customers need during the deployment process. Validation Services MasterControl considers validation an integral part of software solutions for FDA-regulated customers.• Education Services MasterControl provides a variety of educational services to help users become familiar with the software and improve productivity. Project Management Services MasterControl offers project management services to help alleviate the challenges of project management and ensure successful implementation of any MasterControl product. Best practice guidelines taught by professionals with years of experience provide customers with the knowledge necessary to implement and use MasterControl throughout the enterprise. This provides a single point of accountability and communication for the entire project. This ensures that the customer’s system is appropriately tested and verified to meet the design functionality. Integration Services In addition to using MasterControl software to automate internal processes. it may choose to assimilate or “transfer” OQ documentation as part of its overall validation effort. manufacturing execution systems (MES). MasterControl’s Connections Toolkit™ enables companies to bridge that functionality by integrating MasterControl with third party systems. MasterControl maintains several levels of support. which is completed at the customer’s site and assisted by MasterControl experts. TOQ provides completed validation and support documentation of IQ/OQ tests performed at MasterControl. Through this service. Examples may include enterprise resource planning (ERP). and product data management (PDM) applications. An experienced MasterControl Project Manager will provide management expertise. making it easier to re-validate future upgrades. All these options are put in place to provide greater customer satisfaction. and communicate critical milestones. these connection points can vastly improve a company’s overall performance and automation. saving both time and money. MasterControl’s continuum of products and services address different levels of validation needs based on individual risk assessment. MasterControl integrates well with many major software applications typically used by companies. MasterControl’s unique continuous validation approach dramatically cuts the time. customer resource management (CRM). In some cases there are many connection points between MasterControl’s system functionality and the functionality of other applications. • • • • • Solutions Overview 3 . serve as a project champion. ranging from online self-help to in-person assistance. the Education Center is ready and anxious to assist. companies frequently deploy a variety of other third-party software applications. MasterControl Validation Execution Services To improve the speed and productivity of a company’s execution of the validation process. MasterControl services includes the IQ/OQ Validation Execution Service. When properly configured. pain. thereby making every department more effective and efficient.

110 Salt Lake City. REV: 001 4 MasterControl Software Solutions Overview Fax: 801. Functional Requirement Specifications (FRS).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. as well as a final report for the overall validation project. MasterControl GxP Documentation This service provides documentation activities throughout the lifecycle of a project as it pertains to FDA requirements. MasterControl QMS and QEM solutions include quality management. OQ.S.mastercontrol. and Risk Management Plan. User Requirement Specifications (URS).de © 2010 MasterControl Inc. Some of the deliverables include the Validation Plan.800.). policies. In addition.mastercontrol.• MasterControl PQ Validation Execution Services Based on usage. submissions management. MasterControl produces software solutions that enable regulated companies to get their products to market faster. UT 84121 United States Phone: 800.mastercontrol-global. For more information about MasterControl. product lifecycle management. MasterControl securely manages a company’s critical information throughout the entire product lifecycle. easy to validate and easy to use. and more.9117 ( document management/document control. bill of materials. or call: 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. training management. PQ and validation activities. +44 (0) 1256 325 949 (Europe). visit www. All rights reserved. Supported by a comprehensive array of services based on industry best practices.7088 www. MasterControl provides our customers with a complete information management solution across the entire enterprise. Our software is known for being easy to implement. In addition. Ste.825. Corporate Headquarters: MasterControl Inc. customers can expect testing summary reports concerning their Mendelstrasse 11 48149 Muenster Germany Phone: +49 (0) 251 980 2140 Fax: +49 (0) 251 980 2149 www. MasterControl creates a custom PQ protocol to meet the client’s protocol. and Email: info@mastercontrol. 3000 E.825. This includes activities from the project’s validation planning stage through its final reporting and acceptance of the system.mastercontrol. or +81 (03) 6801 6147 (Japan) MasterControl Inc.942. audit management. • About MasterControl Inc. while reducing overall costs and increasing internal efficiency. supplier management. onsite assistance ensures the timely execution of the customer’s protocol. 6322 S.

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