Our System - for Large-scale Enterprises
Small Businesses | Midsize Companies | Large-scale Enterprises
Regulated companies with thousands of employees in sites scattered across the country or around the world face quality management challenges that are unique to their size and the complexity of their operations. Whether it's a giant FDA-regulated pharmaceutical company with a dozen products in Phase III clinical trials, or an ISO-certified high-tech company that has grown in leaps and bounds through acquisition, a large-scale company faces intense market competition and tremendous pressure to boost profits.
In terms of quality management, large-scale companies must manage enterprise-wide quality processes and at the same time control local processes in individual business entities. The high-tech company that has made five acquisitions might find itself with five separate systems. The pharmaceutical company with a different division for each product in development might have a wide range of compliance needs that are not fully met by a single enterprise-wide system.
The MasterControl™ integrated quality management suite is a configurable, off-the-shelf, and easy-to-use software solution that allows continuous FDA and ISO compliance. MasterControl automates, streamlines, and effectively manages document control, change control, training management, audits, corrective/preventive action (CAPA), customer complaints, and other forms-based quality and business processes under a single Web-based platform.
There are three key factors that make MasterControl an ideal solution for large companies in regulated industries:
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MasterControl is designed not only to help companies attain compliance, but to sustain it year after year by: (1) automating and streamlining quality processes to make the compliance environment simpler; (2) providing advanced capabilities that anticipate, if not eliminate, common quality issues that cause noncompliance; and (3) optimizing quality processes to promote efficiency and reduce overall cost of compliance.
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Connectivity and interoperability could pose special challenges for large-scale companies that (1) have invested substantial amounts in electronic repositories that are good for storing SOPs, engineering drawings, and other documents necessary for compliance, but are incapable of controlling other critical quality processes such as training and corrective/preventive action (capa); and those that (2) rely on enterprise applications such as ERP, CRM, and MES that are not connected to the quality management system.
MasterControl is especially designed to connect people, processes, and data for a holistic quality management. MasterControl's advanced connectivity allows large companies to leverage their existing repositories by integrating them with robust MasterControl applications without expensive custom coding.
Likewise, companies currently using ERP, CRM, and other enterprise applications can easily integrate these systems with MasterControl modules designed to control specific quality processes (capa, training, audit, change control, nonconformance) and allow the exchange of files and data between MasterControl and the other systems.
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MasterControl offers robust software, plus the appropriate tools and services necessary for successful implementation and validation, including:
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Continuous Validation: For FDA-regulated companies, MasterControl offers a ?continuous validation? approach that dramatically cuts the time, pain, and cost of validating a system. MasterControl's continuum of products and services address different validation needs based on individual risk assessment.
- Product Training: MasterControl's Professional Services team has developed a comprehensive training program that serves as a foundation for successful project implementation and helps companies realize software ROI faster. The team conducts training at MasterControl's state-of-the-art Training Center in Salt Lake City and also at customers' facilities.
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Technical Support: Choosing MasterControl means getting the necessary technical support to ensure project success. MasterControl offers the expertise, infrastructure, and flexibility to meet every customer's needs, from initial installation to regular maintenance.
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