MasterControl Products: GxP Process Management, Quality Management, Document Management, and Audit Management Software Systems
Integrated GxP 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.
MasterControl Documents™
MasterControl Collaboration™
MasterControl CAPA™
MasterControl Change Control™
MasterControl Training™
MasterControl Nonconformance™
MasterControl Audit™
MasterControl Customer Complaints™
MasterControl Process™
MasterControl PDF Publishing™
MasterControl Submissions Gateway™
MasterControl SOX™
MasterControl Enterprise ™
MasterControl Rules ™
MasterControl Projects™
MasterControl Document Connections™
MasterControl Toolkit™
MasterControl Transfer OQ™
MasterControl Deviations™
MasterControl Electronic Batch Records™
MasterControl CAPA MD™
MasterControl CAPA Pharma™
MasterControl DHF Jumpstart™
Mastercontrol DHF Express™
Mastercontrol Customer Complaint MD™
Mastercontrol Customer Complaint Pharma™
Mastercontrol GCPDocs Express™
Mastercontrol GCPDocs JumpStart™
Mastercontrol Copies™
Mastercontrol Bill of Materials™
MasterControl Business Process Library™
MasterControl Business Submissions Locker™
MasterControl Equipment Calibration™
MasterControl Equipment Maintenance™
MasterControl Out of Specification™
MasterControl PDM Connector for SolidWorks PDMWorks™
MasterControl PDM Connector for PTC's Pro/Intralink™
MasterControl PDM Connector for PTC's Windchill™
MasterControl Kofax Interface™
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 helps companies maximize their intellectual assets by automating, simplifying, and optimizing the process of collaboration in documents-based projects.
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 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 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 a ny change to a document or process that warrants new training will automatically invoke training tasks upon approval of the change.
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 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 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 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 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 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? 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.
For companies seeking compliance with the Sarbanes-Oxley Act, MasterControl SOX is a complete and easy-to-use solution that automates and effectively manages business processes, including voluminous documents, records, and SOPs. It includes a pre-configured form that documents and collects data pertaining to risks, internal controls, and tests. It links every risk with its control and test through pre-built workflows. It allows testing to be automatically scheduled and incorporates escalation to ensure that tests are completed.
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, 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 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 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 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 (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, 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, 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 streamlines the handling of BOMs and helps companies overcome common BOM-related predicaments.
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 offers Business Process Library subscriptions that allow companies to pick and choose suitable solutions according to their specific needs.
MasterControl Submissions Locker MasterControl Inc.?s Submissions Locker is an indispensable tool that can be utilized throughout a submission's lifecycle.
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 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 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'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'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'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.
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 GCPDocs JumpStart provides a solution for collecting, organizing, and reviewing all the documents required to meet the GCP requirements.
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