Medical Device Process Automation Software Systems


MasterControl Medical Device Process Automation Software Systems Automates GxP Processes from Product Concept to Help Medical Device Companies Accelerate Time to Market and Ensure Compliance with 21 CFR Part 820 QSR, ISO 13485, and ISO 14971

Most medical device manufacturers use forms to collect data from customers, employees, vendors, and contractors. In the FDA and ISO environments, forms are heavily used to perform such data-capture activities as audits, out-of-specifications, nonconformances, deviations, corrective/preventive actions, and customer complaints. MasterControl provides medical device process automation software for helping manufacturers in managing their data and processes more efficiently.

In order to stay on top of these intense business and regulatory demands, companies of all sizes are turning to the MasterControl's medical device process automation systems family of off-the-shelf, configurable software products to automate and innovate document control and change management processes. In 1998, MasterControl Documents became the first document management software to enable pharmaceuticals and other FDA-regulated industries to meet FDA GxP requirements and comply with 21 CFR Part 11.

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How can MasterControl Medical Device Process Automation Software Benefit You?

MasterControl’s medical device process automation software is an integrated part of the MasterControl quality management suite, automates, streamlines, and effectively manages medical device forms-based processes throughout the organization to help ensure compliance with FDA regulations, ISO standards, and other regulations.

Recognizing that validating a medical device process automation software solution and keeping it in a constant state of validation is critical to FDA compliance, MasterControl offers comprehensive, full-cycle validation, including IQ, OQ, and PQ validation tests. MasterControl continuously develops new methods to cut the time involved in validating a system and to make it easier to validate software upgrades, both of which are essential in lowering overall validation cost.

Features of Medical Device Process Automation Systems

Here are some of MasterControl Process powerful features:

Efficient Forms: MasterControl automates any forms-based process, including routing, notification, escalation, and approval.

  • Routes can be created based on a company's unique needs within medical device process automation system. For example, forms can be routed for data entry/data collection and approval. MasterControl incorporates escalation of overdue tasks. System administrators can easily create a variety of individually tailored user and security roles.
  • MasterControl process is Web-based so employees, customers, vendors, and others involved in forms-based processes can perform their tasks from virtually anywhere. MasterControl medical device process automation software provides a centralized repository for easy access, search, and retrieval of forms by all authorized users.
  • MasterControl medical device process automation system tracks forms by status or history. A document will show as either in process or complete if tracked by status. The revision or approval history of documents can also be reviewed using the history feature.
  • Completed forms are indexed and stored, so users can search on the contents of the form.
  • Forms can be signed and approved electronically. Signature manifestation, name, date, time, and meaning of electronic signature can be appended automatically to each document. MasterControl's electronic signature features in medical device process automation software comply with the FDA's 21 CFR Part 11 requirements.

Flexible Form Design: Forms created in Microsoft Word, Excel, or PowerPoint can be converted to HTML, so end users will see the same form and won't need new training. A company may also improve existing forms or design new ones to suit its needs.

Offline Forms: Off-site and traveling users or external parties (customers, vendors) can complete forms and stay in the loop even without being connected to the MasterControl medical device process automation system. They can complete forms offline and then upload.

Form-to-Form Launching: A form can be launched directly from another form within a medical device process automation system, connecting one process to the next. Not only does MasterControl streamline this process, but it also maintains the links so one can review a completed process and easily see what triggered that process.

Document Approval via Forms: Some forms-based processes are so tightly connected with the document approval process, requiring the same signatures for both. With this feature, the process is streamlined. A form and the documents linked to it can be approved all at once, avoiding repetitive steps.

Conditional Routing: Quality-related tasks can be routed to different users depending on data entered into the form. For example, a complaint can be routed to the appropriate product team by selecting the product from a drop-down field.

Supervisor Route: Many forms-based processes require approval by a supervisor no matter who initiates the process. With MasterControl medical device process automation software, you can add the supervisor to forms routes. It can also be added in succession, so the route will move from a supervisor to that person's supervisor, and so on, along the hierarchy.

Analytics and Reporting: Data captured on forms is automatically entered in a SQL database. Companies can use built-in tools to filter the data, and then chart results for instant analysis. MasterControl medical device process automation system allows advanced analytics and reporting capability to provides standard and customized reports to help increase management oversight.

For More Details About Medical Device Process Automation Software Systems

To learn more about medical device process automation software systems, please feel free to contact MasterControl representative today.