MasterControl connects all quality processes—from document control and training management to CAPAs and complaint handling—without placing any burden on your already overwhelmed IT department. According to your individual business needs, you may also choose to complement your software solution with any combination of MasterControl’s wide array of services such as data migration, education, process/consulting implementation, integration, project management, technical support, validation and configuration services.
Maintains a Continual State of Audit Readiness
MasterControl gives you the assurance of compliance any time an inspector or auditor shows up and allows all departments to participate in the quality process. MasterControl enables efficient execution of audits, streamlines the capture and management of findings and responses, facilitates the effective planning and scheduling of audits and resources, and simplifies the reporting on resulting data.
MasterControl effectively manages the entire audit process from beginning to end and ensures that issues raised during audits can be properly addressed. Pertinent information from audit observations is automatically captured and entered into appropriate action forms (e.g., CAPA, SCAR, Issue Review, etc.). The system serves as an audit workspace that allows teams to efficiently manage information such as audit type, date, summary, scope, conclusion, observations, etc. You can create customizable reports and take advantage of the system’s online charting functionality to increase visibility and handle risk, suppliers, and quality events without stress. With MasterControl, you are able to effortlessly maintain data integrity all the way from auditor entry and peer review through to the creation of final audit reports.
Accelerated, Efficient Compliance
As quality standards continue to proliferate and increase in stringency, companies doing business in regulatory environments must continually reevaluate the efficacy of their compliance practices. Ensuring effective compliance oversight can be challenging, particularly in today's fluid regulatory landscape.
MasterControl enables companies to maintain regulatory compliance efficiently and affordably. MasterControl software solutions are specifically designed to automate and help you efficiently manage quality processes to ensure compliance with FDA 21 CFR Part 11 regulations, ISO quality standards, and other regulatory requirements. MasterControl is an automated enterprise-level compliance management tool that allows you to define, track, manage and report all of your quality processes- everything from CAPA to risk management - across the enterprise in one centralized database rather than having to track those processes across a host of disparate systems. This reduces your cost of compliance, saves your organization money, and increases your competitive advantage.
Closed-Loop System with No Loose Ends
Industry trends indicate that market leaders are increasingly adopting a closed-loop approach to quality that bi-directionally unites people, processes, and data across the value chain. This approach connects quality from design and procurement stages all the way through manufacturing and service.
MasterControl software is based on a closed-loop methodology that ensures all required activities are completed quickly and that information is always up to date. This methodology helps companies create a culture of quality and ensures that every single employee across the value chain plays a role in maintaining that quality culture. Actions taken along every node of the value chain affect product quality as it moves downstream. MasterControl helps eliminate any hindrances to quality by creating feedback loops that allow performance data to flow back upstream along the value chain. It acts as the common platform for cross-functional collaboration and communication that connects employees and processes via robust technology. With MasterControl’s closed-loop system, you’ll have a better handle on departmental availability, quality, and efficiency.
The integration of enterprise software systems and data sources through an electronic quality management system (EQMS) like MasterControl is an increasingly more common occurrence among industry leaders because it results in demonstrable benefits. MasterControl serves as a hub between traditionally disparate systems and can play a vital role in decreasing your risk, reducing your overall costs, and getting your products to market faster.
Automates Routine, Time Consuming Tasks
Automating repetitive quality tasks allows professionals to keep their focus on key business drivers like innovation and speed to market. MasterControl software eliminates labor-intensive responsibilities like routing documents for approval, distribution, or storage.
MasterControl solutions allow companies to eliminate paper-based quality processes and dramatically increase manufacturing efficiency whilst improving their ability to maintain compliance with regulatory standards. The system ensures total control of all documents versions and revisions. Plus, an automated quality management system like MasterControl decreases the likelihood of human error, precludes time-to-market delays, and prevents regulatory penalties. Some of the features and benefits provided by MasterControl solutions include:
- Better control over “rogue” documents
- Configurable, time-based escalation features
- Real-time, repeatable email notifications
- Unlimited predetermined and ad-hoc routing steps
- Automatic document replacement from draft to release to archive
- Electronic signature and approval history tracking
- Automatic distribution of documents upon approval
- Maintains documents in a secure, Web-based repository
- Cross-linking of complementary documents
For More Information on Quality Management Software
For more information about the benefits of using MasterControl quality management software, please feel free to contact a MasterControl representative.