Preventive Actions

Software for the Automation of Corrective and Preventive Actions

The software for corrective and preventive actions from MasterControl™ automates and manages the CAPA process in an efficient and cost-effective manner. Here are some of its robust features to ensure your system is always Compliant, Connected, and Complete

View Videos

Improving Quality with MasterControl (2:59)

Using MasterControl for FDA Compliance (3:53)

Using MasterControl for ISO Certification (2:17)

Compliant.

Sustained Compliance: MasterControl not only helps companies within FDA and ISO environments attain compliance, it helps them sustain it by strengthening and streamlining the process for corrective and preventive actions.

Increased Efficiency Through Automation: MasterControl automates all tasks pertaining corrective and preventive actions, including notification, follow-up, and escalation of overdue assignments. Automation helps simplify the compliance environment, making it easier to stay compliant.

Best-practice electronic forms and workflow routes: Includes an "8D" process to guide the quality team through every step of CAPA implementation, from identification of the problem to investigation of root cause through correction of the problem and prevention of recurrence. Best-practice forms can be used as is or customized.

Centralized Repository: All corrective and preventive actions are stored in a secure, centralized repository, making it easy to search and retrieve them during an FDA inspection or a quality audit.

Analytics and Reporting: MasterControl's advanced analytics and reporting capability provides standard and customized reports. CAPAs can be summarized in multiple levels such as by product, department, and root cause. MasterControl includes dashboard and drill-down features. With its scheduling functionality, CAPA reports can be automatically sent to a user on a regular basis, or on specific dates in the future.

Connected.

Integrated Quality Management: MasterControl integrates the CAPA process with other quality processes for a holistic approach to quality management

Easy Access: MasterControl CAPA is Web-based so it can connect employees, suppliers, contractors, and others involved in corrective action processes regardless of location. Through the Internet, customers, vendors, and others outside the company can submit a form, such as customer complaint or product issue report, that could lead to a CAPA. Off-site and traveling users can also complete forms pertaining to the CAPA process without being connected to the MasterControl system. They can complete forms offline and then upload.

Integration with Quality Processes: MasterControl CAPA seamlessly integrates with the change control, training, and other quality processes for a more efficient and effective system. For example, a CAPA that causes a change in product design or function will automatically invoke training tasks upon approval of the change, or a customer complaint serious enough to cause a CAPA will be automatically escalated.

Form-to-Form Launching: A CAPA form can be launched directly from another form (i.e., customer complaint, audit findings, etc.) to streamline the CAPA process. Links are maintained so users can review a completed process and easily see what triggered the CAPA.

Complete.

Enterprise-wide Product Application: MasterControl can handle every department's forms- and documents-based processes, making it an ideal enterprise-wide solution. MasterControl offers robust software, plus the appropriate tools and services necessary for successful implementation and validation.

Continuous Validation: For FDA-regulated companies, MasterControl offers a "continuous validation" approach that dramatically cuts the time, pain, and cost involved in validation. MasterControl's continuum of innovative products and services include MasterControl Transfer OQ and MasterControl Automated OQ.

Product Training: MasterControl's Professional Services team, consisting of former ISO auditors and system administrators, 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.

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.

Integrates with Other Applications: MasterControl can integrate with other applications like ERP, LIMS, accounting, and human resources applications to accommodate departmental needs.

Simple CAPA Form: A CAPA may stem from different departments within an organization or even from outside (customers, suppliers, etc.). With MasterControl, initiating CAPA can be made simpler for everyone. A CAPA form can be configured to show the initiator only the relevant information to this step and to require completion only of fields related to data entry.

Easy to Search: A standardized Google-like search window is available throughout the application, which means all authorized users throughout the organization can search and retrieve CAPAs and pertinent documents, as well as search for open corrective and preventive actions (CAPAs) and related tasks.

Easy to Find: MasterControl's Organizer, similar to Windows Explorer, is an easy-to-use tool that helps users find and access documents quickly. Every department can maintain its own Organizers and documents can be stored in multiple Organizers. System administrators can control and automatically update the documents through a dynamic link in the InfoCard.

Automation of Forms-Based Processes: Any forms-based process unique to a department (i.e., application forms for HR, customer satisfaction survey forms for Customer Service Department) can be automated. A department can keep the look and function of existing forms or create entirely new ones