Quality improvement must be a continuous effort in the regulated environment, and MasterControl's quality improvement software was designed with this principle in mind. Existing GxP regulations and standards, whether FDA or EMA or ISO, are meant to promote high-quality products and encourage quality improvement. For regulated companies, there are two key components in improving quality: corrective and preventative action (CAPA) for fixing quality issues and quality management system for ensuring continuous improvement and risk management.
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GxP regulations (such as FDA, MHRA, EMA, and MHLW rules), guidelines (EU Annex 11 and ICH), and standards (ISO, EU GMP) share basic principles pertaining to quality improvement. In one form or another, they consider the following as essential part of effective quality improvement systems:
Controlled Processes and Documentation: All quality processes must be controlled and properly documented. Standard operating procedures are necessary to provide instructions for implementing processes; good SOPs also cover regulatory requirements and how to comply with them. Processes and documents are scrutinized during inspection and serve as a basis for evaluating compliance. Robust quality improvement software can automate quality processes and the corresponding documentation required.
Training: In addition to hiring personnel with the proper training and qualification, GxP standards require appropriate training on specific procedures and SOPs that affect quality processes. When SOPs are amended substantially or CAPAs are implemented, re-training may be required. Electronic quality improvement software systems can help improve the training process for compliance purposes.
CAPA: Even the most effective quality system is bound to have issues. What is important is that there is a process in place for implementing CAPAs and for preventing the issues to happen again. CAPA is a complex process, but a tool such as quality improvement software can greatly simplify it.
Internal and External Feedback: In regulated environments, feedback includes audits and customer complaints. In the former, an internal auditor periodically examines processes to ensure compliance. Internal audits are critical in preparing for the external audit - the inspection by regulatory agencies. With customer complaints, the feedback comes from the outside. The regulated company must address issues identified in audits and customer complaints in a timely manner. Increasingly, companies are turning to electronic quality improvement systems to ensure timely response to issues.
Risk Management: Risk management is a systematic approach for assessing and controlling risks to the quality of the product. It encompasses such processes as audit and CAPA, both of which entail a closer look at processes and issues. Effective quality improvement software provides risk management capabilities in addition to managing the audit and CAPA processes.
Validation: In the FDA and EMA environments, validation is required by regulatory law. Validation entails testing and documentation to show that a process or system meets its pre-determined specification and quality attributes. If a company uses quality improvement software for processes that impact product quality, then the software must be validated.
Controlled Processes and Documentation: MasterControl Documents™ provides a centralized web-based repository for all documentation. It automates tracking, search, retrieval, routing, review, and approval of documents. MasterControl Process™ automates any forms-based process, offering best-practice forms that prompt users with selected data to reduce data entry and avoid common data-entry mistakes. Together, MasterControl Documents and MasterControl Process can serve as a centerpiece for effective quality improvement systems.
Training: MasterControl Training™, which is part of MasterControl quality improvement software, streamlines the training process by automating assignment and tracking of training tasks, as well as dissemination of training materials and testing. It allows sequencing of courses, so when a prerequisite course is completed, the system will automatically launch the next course.
CAPA: MasterControl CAPA™ offers best-practice features that will guide the quality team on a step-by-step basis throughout CAPA implementation. It automates routing, notification, escalation, and approval of CAPAs. When integrated with quality improvement software systems, it can track incidents in subsystems that can escalate to CAPA.
Internal and External Feedback: MasterControl Audit™ is an easy-to-use solution that automates audit scheduling, assignment and tracking of tasks, as well as tracking of audit observations. It offers templates and workflows that can be customized for specific regulatory requirements. MasterControl Customer Complaints™ streamlines all tasks pertaining to the handling of customer complaints, including notification, follow-up, and escalation of complaints. It features a best-practice form that covers these three key steps: processing of customer complaint, investigation, and issue resolution. Both applications are part of MasterControl integrated quality improvement software.
Risk Management: MasterControl Risk™ offers a holistic approach to risk management. It standardizes the process for collecting and managing tasks. It automates review, approval, and execution of tasks pertaining to risk management. MasterControl quality improvement software also features analytics and reporting tools for faster and effective risk analysis.
Validation: MasterControl offers full, front-to-back validation services and solutions-from planning to IQ, OQ, and customized PQ protocol creation, systems configuration, risk management, and customized validation testing and reporting.
Compliant: MasterControl quality improvement software systems provide capabilities that address requirements across a spectrum of regulations and standards for life science companies, manufacturing industries, and service-oriented organizations such as hospital systems and government agencies.
Connected: With MasterControl quality improvement software, all critical quality processes can be connected for a seamless quality management system. It provides a single, web-based platform for such processes as document control, audit, CAPA, training control, change control, risk management, supplier management, submissions management, and BOM management.
Cost-effective: MasterControl quality improvement systems help regulated companies increase efficiency, optimize productivity, and accelerate compliance for a lower overall compliance cost.
To learn more about MasterControl's quality improvement software, contact a MasterControl representative.