High-Tech - Semiconductors, Computers, Telecommunication Industries
Integrated Quality Assurance Software - ISO 9000 Compliant Software to Improve Paper or Manual Quality Assurance System Processes
There are few industries that change as rapidly as those in the high-tech industry. Products ranging from semiconductors to computers to telecommunication systems are becoming obsolete quicker than ever. High-tech companies face the constant challenge to innovate, improve quality, and reduce production cycles and costs in order to stay competitive.
Most high-tech companies adhere to ISO standards, such as ISO 9000 quality management standards and ISO 14000 environmental management standards, for greater acceptance in the international market. High-tech companies that are publicly traded or those planning to go public or are acquired by public companies also need to comply with the Sarbanes-Oxley Act (SOX).
For high-tech companies and suppliers, the ultimate goal is to manufacture high-quality and reliable products. To achieve this goal, they must address many quality-related challenges, including:
- High Costs: Manufacturers with multiple facilities and employees in different locations may find it cheaper initially to maintain separate quality systems, but the inefficiency of paper-based or hybrid systems that are not connected can cost a lot in terms of man-hours.
- Search and Retrieval Issues: It's difficult to search and retrieve voluminous documentation (SOPs, policies, etc.) stored in disparate paper-based and electronic systems, especially during ISO and customer audits.
- Inefficient System: For companies using a paper-based quality system, the change control process can be long and cumbersome, requiring face-to-face meetings to discuss changes and obtain approval and signatures. Any rejected change means even more meetings.
- Poor Turnaround: A change control process that's not connected to other quality processes (CAPA, customer complaint, training, etc.) is likely to cause a poor turnaround in change implementation.
The MasterControl? integrated quality management suite is a configurable, easy-to-use solution that helps high-tech manufacturing companies attain and sustain ISO certification and regulatory compliance. MasterControl connects different departments with each other and with data and processes under a secure and centralized Web-based system. This connectivity helps promote quality throughout the enterprise by allowing management to continuously monitor and proactively improve the quality system.
Roll over the list of solution categories below to view the related MasterControl product, then click to go to that solution's product page.
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 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.
The MasterControl CAPA™ solution 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 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 control 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.
The MasterControl Audit™ solution 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 Submissions™ 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 Customer Complaints™ streamlines the complaint-handling process and reduce 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.
The FDA's 21 CFR Part 11 requires full-cycle validation of electronic record-keeping systems to assure the accuracy, reliability, and consistent intended performance of the system. MasterControl provides comprehensive validation services, including onsite IQ (installation qualification), OQ (operational qualification), and PQ (performance qualification) tests to ensure that the system is fully compliant. For companies wanting to perform their own validation, MasterControl offers a Validation ToolKit, which provides a detailed, pre-written validation test protocols and scripts.
For companies seeking compliance with the Sarbanes-Oxley Act (SOX), the 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.
For many small pharmaceutical and biotech companies, GCP stands for "Great Complicated Paperwork" rather than “Good Clinical Practices.� The voluminous paperwork is an integral part of meeting the international, ethical, and scientific quality standards for designing, conducting, recording and reporting trials that involve human subjects, but that doesn’t make it any easier to handle. Small contract research organizations (CROs) commonly feel overwhelmed by all the documentation required by the standard.
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