Medical Device Audit Management Software Systems


MasterControl’s Medical Device Audit Management Software Systems Meet ISO 13485 and 21 CFR Part 820 Regulations

MasterControl Audit process management software, an integrated part of the MasterControl quality management suite, automates and manages medical device audit management systems in an efficient and cost-effective manner.


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Q&A: Compliance with 21 CFR 820 and ISO 13485 Using MasterControl



21 CFR Part 820 regulations require medical device companies to monitor their quality systems using a paper or electronic medical device audit system. Quality audits are considered necessary according to the Current Good Manufacturing Practice (CGMP) principles outlined in the FDA’s Quality System Regulation (QSR). Since companies that manufacture medical devices must adhere to ISO and FDA standards, the following outline provides some of the regulations that require the execution of quality audits in the system.

For ISO-certified medical device manufacturers, ISO 9000 requires evaluation of the quality system and examination of audit results by management. On the other hand ISO 14000 calls for company to run internal environmental management audits. ISO 13485 requires companies to conduct an internal audit (or a medical audit) on a regular basis to monitor and measure quality. This can be easily achieved by implementing MasterControl's medical device audit management software.

In order to attain and sustain CGMP and ISO compliance, medical device manufacturers may incorporate an integrated quality management suite such as MasterControl, which includes medical device audit software, . MasterControl offers comprehensive, full-cycle validation services, including IQ, OQ, and PQ validation tests as required by 21 CFR Part 11. MasterControl continuously develops new methods to cut the time involved in validating a system and makes it easier to validate software upgrades. Both of these factors are essential in lowering overall validation cost.

Here are some of the robust features of the MasterControl medical device audit management software that ensure your quality system is always compliant, connected, and complete:

Compliant with Medical Device Audit Management Software System Regulations

Compliance is an attribute that requires medical device audit management systems to run with optimized quality processes. Such a system must be capable of running an internal or third-party audit at any stage and also be compliant with FDA or CGMP quality requirements. MasterControl medical device audit management software ensures compliance that is easily sustainable through the diverse product feature list. For starters, our software automates all tasks pertaining to a medical device audit, including notification, follow-up, and escalation of overdue assignments. In order for all employees to remain informed about different processes, it is necessary to store all documentation in a single consolidated location. This is achieved by maintaining a centralized repository that stores all audit-related documents. Conducting searches and retrieving documents for customers or for ISO audits is no longer a hassle. On the same lines, MasterControl provides revision control that maintains only the current version of documents for access by employees.

The success of any medical device company lies in the capability to analyze different aspects of the business and make important decisions based on certain evaluations. MasterControl’s medical device audit management system provides the ability to dynamically capture, trend, and link data needed to solve problems and improve processes. Through the reporting features, management can retrieve reports that include medical device audit summaries, audit details, findings by root cause, audits by standards, audits by auditor, and open findings. Moreover, management can also schedule automated audits, which eliminates the need to remember to launch tasks manually.

Connected Medical Device Audit Management Software Systems

It is important to connect audit process with the different quality processes in the system so that audits may be conducted easily without any interruption. MasterControl encourages integrated quality management by providing a holistic approach for running audits. This also provides the opportunity to have an integrated system where processes are streamlined in different steps or individual blocks. Audits begin with preparation, move on to scheduling from where they are executed, and presents findings that can be verified after the audit is completed. MasterControl provides online medical device audit management software which ensures that employees, suppliers, contractors, and others involved in audit process are easily connected and involved in the audit. Thus, both processes and people can easily interact and collaborate together for a successful audit execution. Continuing on the same lines, MasterControl’s medical device management system is all about linking different modules together so that effective quality management is easily achieved.

A corrective and preventive action (CAPA) form can be launched directly from another form, such as an Audit Finding form. Pertinent information from the Audit Finding form will be automatically entered into the CAPA form that reduces data entry and saves time. A medical device audit management system also shows the history of the entire process. In order to allow users to review a completed process, links are maintained that also allow users to view what triggered the CAPA. Managers can be given more control of workflow by making completion of a task dependent on another task. This reduces cycle time by prompting users immediately to their next task. An innovative dependency tree illustrates relationships between dependent processes.

Complete Medical Device Audit Management Software Systems

MasterControl Audit is an enterprise-wide product application as it can handle every department's forms- and document-based processes. No matter what the magnitude of business operations is MasterControl can integrate with other applications like ERP, LIMS, accounting, and human resources applications to accommodate departmental needs. The application consists of a Google-like search window that allows authorized users to search and retrieve change control-related tasks and documents throughout the organization. Along the same lines, MasterControl's Organizer, similar to Windows Explorer, is an easy-to-use tool that helps users find and access documents quickly. MasterControl provides the flexibility of allowing each department to maintain its own Organizers. Moreover, documents can be stored in multiple Organizers. Administrators of the medical device audit management system can control and automatically update documents through a dynamic link in the system’s “InfoCard.” Also, the software allows for automation of form based processes such as application forms for HR, customer satisfaction survey forms for Customer Service Department, etc. Automation allows departments to preserve the look and function of existing forms or define new forms from scratch.

More about Medical Device Audit Management Software Systems

For more information about a medical device audit management software for conducting an internal audit, please don't hesitate to contact a MasterControl representative