MasterControl Products: Business Process Management, Quality Management, Document Management, and Audit Management Software Systems

Integrated Business Process Management Software

With more than a decade of experience in the rigorous FDA and ISO environments, MasterControl has developed an integrated software solution that combines industry best practices with the flexibility to meet every customer's unique needs.

The MasterControl™ GxP process management suite consists of configurable, easy-to-use, and connected applications for automating, streamlining, and effectively managing GxP processes throughout the entire product development process from conception to commercialization. Hundreds of companies worldwide rely on MasterControl to facilitate compliance with FDA, and other worldwide regulatory bodies (e.g., GxPs, 21 CFR Parts 11, 210-211, 820, 606), and ISO quality standards (e.g., ISO 9000, ISO 13485, ISO 14000, ISO/TS16949) to improve product quality and safety - and to ensure compliance.

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MasterControl's Documents Module (2:02)

MasterControl Training Module (2:29)

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Document Management Process - MasterControl Documents™

Training Management and Tracking - MasterControl Training ™

Business Process Automation - MasterControl Process™

Audit Management Process - MasterControl QAAD™

MasterControl Applications:

MasterControl All Access™
MasterControl Accident/Injury™
MasterControl Analytics™

MasterControl Documents™
MasterControl ENG™
MasterControl Express Biologics™
MasterControl Guest Connect™
MasterControl MD™
MasterControl Pharma R&D™
MasterControl Process™
MasterControl QMS Event Management Solutions™
MasterControl Submissions Ready™
MasterControl Suite™
MasterControl Supplier™
MasterControl TotalMFG™
MasterControl TotalPharma™
MasterControl Training™
MasterControl QAAD™ - Audit

MasterControl Add-ons:

MasterControl Bill of Materials™
MasterControl Classes™
MasterControl Collaboration™
MasterControl Copies™
MasterControl Document Connections™
MasterControl Enterprise ™
MasterControl Exams ™
MasterControl Mobile™
MasterControl PDF Publishing™
MasterControl Projects™
MasterControl Rules ™
MasterControl Toolkit™
MasterControl Transfer OQ™

MasterControl Business Processes:

MasterControl Integrations & Connectors:

MasterControl Kofax Interface™
MasterControl/Datafarm GxP2eCTD Connector™
MasterControl MS Word Integration™
MasterControl Outlook E-mail Integration™
MasterControl PDM Connector for PTC's Pro/Intralink™
MasterControl PDM Connector for PTC's Windchill™
MasterControl PDM Connector for SolidWorks Enterprise PDM™
MasterControl PDM Connector for SolidWorks PDMWorks™
MasterControl SharePoint Connector™

MasterControl Industry-Specific:

MasterControl Customer Complaint MD™
MasterControl Customer Complaint Pharma™
Mastercontrol DHF Express™
MasterControl DHF Jumpstart™
MasterControl eMDR™
MasterControl GCPDocs Express™
MasterControl GCPDocs JumpStart™
MasterControl Submissions Locker™
MasterControl Submissions Gateway™

MasterControl Documents™

MasterControl Documents helps increase the quality unit's efficiency and effectiveness by automating task assignment/routing, scheduling, follow-up, tracking, escalation, review, and approval of all documents-based processes. It provides a single repository for all documentation, making search and retrieval easy. MasterControl Documents, the core application in the MasterControl quality management suite, integrates all quality processes such as change control, customer complaints, corrective/preventive action, audits, etc., for a closed-loop solution.

MasterControl Collaboration™

MasterControl Collaboration helps companies maximize their intellectual assets by automating, simplifying, and optimizing the process of collaboration in documents-based projects.

MasterControl CAPA™

The MasterControl CAPA system interconnects different quality subsystems and tracks incidents that can escalate into a corrective action. It includes a best-practice "8D" process to guide the quality team through every step of CAPA implementation, from identification of the problem through corrective action. A CAPA form can be launched directly from another form (e.g., nonconformance or deviation report), automatically entering relevant data into the CAPA form, reducing data entry and eliminating errors from manual transfer of information. Through the Internet, customers, vendors, and others outside the company can submit customer complaint or other forms that could lead to CAPA.

MasterControl Change Control™

MasterControl Change Control streamlines the entire change control procedure for faster turnaround. It offers a best-practice form that incorporates priority level and prompts risk assessment and classification of the change as low, medium, or high. Any high-level change implies great impact on the product and is likely to require regulatory filing. Customizable reports provide real-time status not only of change control tasks but of the entire quality system.

MasterControl Training™

MasterControl Training automates assignment and monitoring of training tasks and grading of online exams. It allows sequencing of training courses, so after a prerequisite course is completed, the next one is automatically launched. Provides group sign-off feature for verifying training of large groups of employees. Training management can be 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.

MasterControl Nonconformance™

MasterControl Nonconformance is a robust solution designed to automate, manage, and streamline the process for identifying, evaluating, reviewing, and handling of nonconforming materials, components, parts, and finished products. The solution's best-practice form and five-step process connect all responsible personnel for effective and timely disposition of a nonconformance. This solution offers the choice of maintaining a stand-alone nonconformance process for small-scale, localized incidents, or you may connect it to the CAPA process for automatic escalation when the situation warrants it. training will automatically invoke training tasks upon approval of the change.

MasterControl QAAD™ Audit

MasterControl QAAD™ Audit automates, streamlines, and effectively manages the audit process. It provides advanced tracking capability, from scheduling and planning to execution and completion. MasterControl offers best-practice forms for tracking basic audit information and audit findings. It automates scheduling of all recurring audit-related activities and provides advanced analytics and reporting capability, so managers get a real-time view of the audit process.

MasterControl Customer Complaints™

MasterControl Customer Complaints streamlines the complaint-handling process and reduces the lifecycle from submission to resolution. A simple, three-step process is incorporated in a pre-configured, multi-page form that starts with the processing of a customer complaint, automatically moving to internal investigation, and culminating with a resolution of the issue. MasterControl's advanced reporting capabilities increase management oversight and demonstrate appropriate controls to regulatory agencies. MasterControl is Web-based, so customers can submit complaints from virtually anywhere.

MasterControl Customer Complaints Pharma™

MasterControl Customer Complaint Pharma is a complete solution that automates complaint handling, integrates it with the quality system, and manages complaint resolution swiftly and effectively.

MasterControl Process™

MasterControl Process automates routing, notification, escalation, and approval of any forms-based process for faster turnaround. This solution offers best-practice features that prompt users with selected data to reduce data entry and avoid mistakes common in manual data entry. Forms created in Microsoft Word, Excel, or PowerPoint can be converted to PDF as is, so users will see the same form and won't need new training. A company may also improve existing forms or design new ones to suit its needs.

MasterControl PDF Publishing™

MasterControl PDF Publishing provides automated PDF publishing of document. The product helps preserve record authenticity and improve regulatory and quality compliance by restricting user rights like open, copy, paste or other PDF options.

MasterControl Submissions Gateway™

MasterControl Submissions Gateway facilitates electronic delivery of FDA applications (such as IND, NDA, and BLA) by providing control in assembling and tracking necessary documentation. It provides appropriate templates to streamline the dossier-creation process. MasterControl can be integrated with leading e-submission applications, connecting approved documents and forms-based content with the dossier assembly process, to accelerate submissions.

MasterControl Enterprise™

MasterControl Enterprise a part of the MasterControl integrated quality management suite, provides powerful filtering capability that allows individual business units to manage certain aspects of their processes independently.

MasterControl Rules™

MasterControl Rules, a part of the MasterControl integrated quality management suite, is a configurable and easy-to-use solution for effective monitoring and management of critical quality events and tasks. It also empowers individual users to manage their own tasks more efficiently and effectively.

MasterControl Projects™

MasterControl Projects automates the process of controlling projects, particularly those that are document and/or process-based. It automates task assignment, routing, escalation, and tracking. It streamlines the workflow and provides project transparency that fosters accountability.

MasterControl Document Connections™

MasterControl Document Connections allows companies to integrate their existing electronic repositories ECM, PLM, or other types with MasterControl Training™, MasterControl CAPA™, MasterControl Forms™, and other cutting-edge MasterControl applications. By using this module, integration of MasterControl solutions with external repositories can be made easily and immediately, without expensive custom coding.

MasterControl API Toolkit™

MasterControl API Toolkit allows companies to integrate MasterControl's robust quality management solutions with other enterprise applications to optimize operations. The toolkit enables the exchange of files and data between MasterControl and other software applications.

MasterControl Transfer OQ™

MasterControl Transfer OQ (TOQ) is a key part of MasterControl's continuous validation approach. Based on a company's 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.

MasterControl Electronic Batch Records™

MasterControl Electronic Batch Records, designed based on the Instrumentation, Systems and Automation Society's S88 model (ISA-S88 or S88), is a powerful EBR management solution for automating and controlling batch processes.

MasterControl Copies™

MasterControl Copies, combines several beneficial features related to creating multiple copies into a single product. Functional elements of MasterControl Copies™ include Multiple File Copy, Multiple File Print, Controlled Copies and PDF Binder.

MasterControl Bill of Materials™

MasterControl Bill of Materials streamlines the handling of BOMs and helps companies overcome common BOM-related predicaments.

MasterControl PDM Connectors™

MasterControl PDM Connectors MasterControl’s PDM software interface allows collaboration and redlining on PDF drawings while guaranteeing that the PDF copy in the MasterControl system stays in sync with native files in the PDM software solution.

MasterControl Business Process Library™

MasterControl Business Process LIbrary MasterControl offers Business Process Library subscriptions that allow companies to pick and choose suitable solutions according to their specific needs.

MasterControl Business Submissions Locker™

MasterControl Submissions Locker MasterControl Inc.?s Submissions Locker is an indispensable tool that can be utilized throughout a submission's lifecycle.

MasterControl Equipment Calibration™

MasterControl Calibration is a configurable and easy-to-use solution designed to automate and manage the process of Inspecting and documenting the Calibration process.

MasterControl Equipment Maintenance™

MasterControl Equipment Maintenance is a configurable and easy-to-use solution designed to automate and manage routine and non-routine maintenance and inspection of equipment.

MasterControl Out of Specification™

MasterControl Out-of-Specification is a configurable and easy-to-use solution designed to automate and manage the out-of-specification process, including investigation of laboratory test results, investigation of production records, corrective action and batch disposition.

MasterControl PDM Connector for SolidWorks PDMWorks™

MasterControl's PDM Connector for SolidWorks' PDMWorks solution is easy to use and allows collaboration and redlining on PDF drawings while guaranteeing that the PDF copy in the MasterControl system stays in sync with native files in the PDMWorks™ solution.

MasterControl PDM Connector for PTC's Pro/Intralink™

MasterControl's PDM Connector for PTC's Pro/Intralink solution is easy to use and allows collaboration and redlining on PDF drawings while guaranteeing that the PDF copy in the MasterControl system stays in sync with native files in the Pro/Intralink™ PDM solution.

MasterControl PDM Connector for PTC's Windchill™

MasterControl's PDM Connector for PTC's Windchill solution is easy to use and allows collaboration and redlining on PDF drawings while guaranteeing that the PDF copy in the MasterControl system stays in sync with native files in the Windchill™ PDM solution.

MasterControl Kofax Interface™

The MasterControl Kofax Interface allows MasterControl users to digitally captured and directly route documents to appropriate archives within MasterControl’s secure environment, which saves time and effort, especially in organizing, searching, and tracking documents.

MasterControl GCP Docs JumpStart™

MasterControl GCPDocs JumpStart provides a solution for collecting, organizing, and reviewing all the documents required to meet the GCP requirements.

MasterControl eMDR™

MasterControl eMDR has been designed to meet the requirements for forms processes within the confines of FDA/GxP environments including compliance with 21 CFR Part 11.

MasterControl MS Word Integration™

MasterControl MS Word Integration allows users to stay in the environment where they are most comfortable and where they work on a daily—if not hourly— basis. MasterControl’s integration product lets users search, access, review, and collaborate on critical documents within MS Word.

MasterControl SharePoint Connector™

MasterControl SharePoint Connector complements the Microsoft SharePoint server program to facilitate streamlined business processes and provide incomparable document control. MasterControl offers a seamless, out-of-the-box integration with SharePoint that capitalizes on the benefits of SharePoint while adding truly robust compliance solutions.

MasterControl Supplier™

MasterControl Supplier provides a solution for collecting, organizing, and reviewing all the documents required to meet the GCP requirements.

MasterControl Supplier Deviation™

MasterControl Supplier Deviation creates a formal process where suppliers can request an exception to written specifications. Materials are shipped only after the appropriate individuals have reviewed and approved the request and provided proper justification.

MasterControl HR Finance™

MasterControl HR Finance helps automate the administrative processes that bottleneck the flow and timely completion of essential HR and finance tasks.

MasterControl Exams™

MasterControl Exams is an optional upgrade to MasterControl Training that helps automate the administering and grading of exams, as well as documenting employee competencies.

MasterControl Risk Analysis™

MasterControl Risk Analysis establishes risk evaluation as a separate process. The output is a risk score based on a consistent process, which enables quality departments to reduce the oftentimes subjective nature of quality decision making.

MasterControl Deviations™

MasterControl Deviations automates and manages the process of documenting, investigating, and resolving operational deviations from written procedures and specifications. This solution provides the capability to resolve a deviation efficiently and to use data collected as a basis for continuous quality improvement.

MasterControl Outlook E-mail Integration™

MasterControl Outlook E-mail Integration allows everyday and “everymonth” users alike to access MasterControl tasks from any HTML e-mail client, including Microsoft Outlook®.

MasterControl Express Biologics™

MasterControl Express Biologics allows blood and biologics organizations to affordably resolve typical quality management, compliance, document management, change control, and collaboration pains. The hosted solution is specifically designed to meet the compliance needs of blood, tissue, and eye banks as well as organ procurement organizations.

MasterControl MD™

MasterControl MD offers the utopian solution for medical device manufacturers: an end-to-end software solution that enables companies to get their products to market faster while simultaneously maintaining regulatory compliance.

MasterControl TotalMFG™

MasterControl Total MFG enables regulated manufacturers to get their products to market faster while simultaneously maintaining compliance. The software allows cross-functional teams to efficiently collaborate on critical documents and accelerate the development cycle.

MasterControl Submissions Ready™

MasterControl Submissions Ready allows organizations to accelerate the preparation and organization of submissions documents utilizing FDA- and ICH-compliant submissions templates in combination with MasterControl's unrivaled document management solution.

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