MasterControl CAPA MD™ for Medical Device Companies
Since December 13, 1984, the FDA Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries, or deaths associated with medical devices to notify the FDA of the incident. If these reports indicate a trend, a corrective action is issued and the problem should be corrected with proper follow up and retraining carried out as needed. With a paper-based system and its inherent inefficiencies, implementing this correction is much more challenging than it needs to be.
MasterControl CAPA MD is an easy-to-use software solution designed to automate and effectively manage the CAPA process and integrate it with other quality processes, such as change control, audit, training, nonconformance, and customer complaints, for a holistic approach to quality management.
MasterControl offers a line of validation products and services addressing different levels of validation needs based on individual risk assessment. They are designed to allow "continuous validation" for FDA-regulated companies by making validation of software upgrades easier, faster, and more cost effective.
Here's how MasterControl CAPA MD addresses some of the major challenges that companies face in implementing CAPA:
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MasterControl Corrective Action Software Solution |
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Inefficient System:
Manual CAPA systems are inefficient, requiring tremendous man-hours in terms of routing, obtaining approval and signatures. Finding documents in preparation for inspections and audits is also difficult and time-consuming.
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Efficient System:
MasterControl CAPA MD automates routing, delivery, escalation and approval of CAPAs and all related documents. It provides a centralized repository for all documents, making search and retrieval easy during inspections and audits. |
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Disconnected Processes:
A CAPA may be triggered by Form 483 or audit findings, customer complaints, or some other source. With manual systems, these sources are disconnected, making data collection slow, incomplete, or even inaccurate. |
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Connected Processes:
MasterControl integrates the CAPA process with the rest of the quality system. For example, the resolution of a CAPA might trigger an SOP change and retraining of employees on the new SOP. As another example of connected processes, a CAPA form can be launched directly from another form (such as a customer complaint or nonconformance) to streamline the process.
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Lacks Viability:
The lack of ability to track and monitor causes for CAPAs could result in delayed resolution of issues. Without a coherent reporting system, managers are unable to see the big picture of the quality management system. |
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Automatic Tracking:
The system tracks all routing information and data entered into the electronic form, allowing the CAPA owner to identify bottlenecks and understand the sequence of events during processing.
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MasterControl CAPA MD is an ideal solution for growing medical device companies who need an out-of-the-box, preconfigured document control system based on best practices.
Below is a summary of its key features and benefits:
- Automates Routing, Escalation, and Approval: Automates all CAPA tasks, including routing, notification, follow-up, escalation and approval. Automation helps sustain compliance by simplifying processes.
- Best-Practice Forms: Provides best-practice forms and workflow and is based on an "8D" process to guide the quality team through every step of CAPA implementation. The CAPA form can be configured to simplify the process of initiating a CAPA by showing the user only the relevant information and to require completion only of fields related to data entry.
- Revision Control: Automatic revision control ensures that only the current version of a document is available, so users will not make the mistake of using obsolete or unapproved documents.
- Analytics and Reporting: MasterControl CAPA MD provides standard and customized reports. CAPAs can be summarized in multiple levels such as by product, department, and root cause. MasterControl CAPA MD includes a 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.
- Part 11 Compliant Features: Provides time-stamped audit trail, reporting, and electronic signature capabilities required by FDA's 21 CFR Part 11 regulation. Security features include dual passwords for document approval, password expiration, encryption, and certification and account lockout to stop unauthorized users from gaining system access.
- Form-to-Form Launching: A CAPA form can be launched directly from another form (such as a customer complaint or deviation report), connecting one process to the next. Relevant data from a form are automatically entered into the CAPA form, reducing data entry and eliminating errors from manual transfer of information. Links are maintained so users can review a completed process and see what triggered a process.
- Anonymous Access: Through the Internet, customers, vendors, and others outside the company can submit a form (such as a customer complaint or product issue report) that could lead to a CAPA.
- Integrates with Training: Seamlessly integrates with the training process so a capa that causes an important change (in product design, SOP, etc.) will automatically invoke training tasks upon approval of the change.
- Offline Forms: Off-site users or external parties (customers or vendors) can complete a CAPA form, even without being connected to the MasterControl CAPA MD system. They can complete forms offline and then upload them.
- Document Approval via Form: A CAPA form and documents linked to it can be approved all at once, avoiding repetitive steps.
- Product Training: MasterControl's Professional Services team, consisting FDA industry veterans, ISO auditors, and IT professionals, has developed a comprehensive training program that serves as a foundation for successful project implementation and helps companies realize faster software ROI. The team conducts training at MasterControl's state-of-the-art Education 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.
About MasterControl
MasterControl Inc. is a global provider of GxP process and document management software solutions for life science companies. The MasterControl suite is easy to use, easy to deploy, easy to validate, and easy to maintain. It incorporates industry best practices for automating and connecting every stage of the product development cycle, while facilitating regulatory compliance. By combining an integrated platform with a continuum of risk-based software validation products and services, MasterControl drives down the total cost of ownership and enables customers to extend their investment across the enterprise. Hundreds of companies worldwide use MasterControl for easier compliance, faster validation, and better process management. For more information, visit www.mastercontrol.com, or call 800-825-9117.
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