Medical Device Change Control Software Systems

21 CFR Part 11, Part 606, and Part 211 GMP Compliant Medical Device Change Control Software Systems

In the FDA and ISO environments, the concept of change control is closely interwoven with compliance. Under the FDA's Quality System Regulation QSR for medical device companies ( 21 CFR Part 820 ), a medical device change sontrol software system is required for design changes ( 820.30 ), document changes ( 820.40 ), and production and process changes ( 820.70 ).

To conform to ISO standards, medical device manufacturers must comply with similar requirements. ISO 9000 requires management to examine all changes that might affect the quality system which can be easily done via MasterControl's medical device change control software. ISO 13485 requires control of any changes affecting the quality management system, including product requirements, design, and development changes.

The MasterControl's medical device change control systems is an integrated quality management suite which is configurable and easy-to-use software solution that helps medical device companies attain and sustain compliance. Recognizing that validating a software solution (as required by 21 CFR Part 11) is a necessary component in FDA compliance, MasterControl offers full-cycle validation services, 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.

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How can MasterControl Medical Device Change Control Software Benefit You?

MasterControl's medical device change control software is designed to help medical device manufacturers automate and effectively manage every step of the change control process, from submission through actual implementation, verification, and close of project. Here's how MasterControl can ease some of the major challenges in change control.

CGMP Part 606 Medical Device Change Control System Challenges		MasterControl's Medical Device Change Control Software
Disconnected Processes without Medical Device Change Control System Communication breakdown is likely to happen in companies that rely on disparate tools and processes to manage the quality system. In the context of medical device change control system, this could mean lack of follow-up, late notifications, and tasks not completed by deadline. Suppliers could be making changes without proper and timely notification.		Connected Medical Device Change Control Software MasterControl's medical device change control software is an integrated solution that connects different departments with data and processes under a secure and centralized system. This connectivity vastly improves efficiency through automatic task assignment, routing, scheduling, notification, and escalation of incomplete tasks. MasterControl is Web-based, so even suppliers and others outside the company (off-site or traveling employees) who need to participate in change control can do so from virtually anywhere.
Poor Turn-Around Timeliness is essential in change control. A manual system that relies on paper-based documents to generate necessary data and old-fashioned legwork to route and track submissions and change orders is likely to have poor turn-around for change.		Excellent Turn-Around MasterControl integrates and streamlines the entire change control procedure for faster turn-around. It offers a best-practice form that incorporates priority level (by identifying the change as routine or temporary or emergency), as well as escalations. Plus, reports provide real-time status for all change control tasks.
Training not Integrated with Change Control In a manual medical device change control system, it is difficult for employees to keep up with all the changes in SOPs, policies, and other critical documentation because the training process is not connected to the rest of the quality system.		Medical Device Change Control Software Integrates Training With MasterControl's medical device change control software, the change control process can be integrated with the training application. Any change to a document that warrants new training will automatically invoke training tasks. MasterControl can automate the process of distributing online exams with the training, and even includes automatic grading.

Features of Medical Device Change Control Software

Change control is a complex process, but MasterControl's medical device change control software can help medical device manufacturers standardize and simplify change control procedures in order to increase efficiency and effectiveness. MasterControl Change Control software includes:

Best-Practice Form:A pre-configured, multi-page form helps collect and track data every step of the way in the change control process: submission, evaluation, approval/ rejection, implementation, verification, and close of project.

• A section in the change submission form captures such information as: description of change, justification, and impact. Both original and revised documents can be attached for easy comparison.
• An initiator can use one form for multiple changes in medical device change control system, depending on how many documents/items are affected by a change. For example, the form for a change in a component used in making 10 products can have 10 attachments, greatly streamlining the process.
• The initiator is asked to evaluate the change in terms of training, validation, and regulatory requirements, prompting risk assessment. It also asks for classification of the change as low, medium, and high. Any high-level change implies great impact on the product and is likely to require regulatory filing.
• The ability to prioritize is incorporated because the form asks the initiator to categorize the change submission as routine or temporary or emergency.
• Additional forms can be customized based on the company's special needs.

Form-to-Form Launching:A change submission form can be launched directly from a Corrective/Preventive Action (CAPA) form, connecting one process to the next in the medical device change control software. 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 the change. Relevant information from the CAPA form will be automatically entered into the change submission form, reducing data entry. It also shows the history of the entire process.

Document Approval via Forms:The change submission form and the documents linked to it can be approved all at once, avoiding repetitive steps.

Dependent Routing:Completion of a task can be made dependent on another task to give managers more control and reduce cycle time by prompting users immediately to their next task. An innovative dependency tree illustrates the relationships between dependent processes.

Dynamic Organizers:MasterControl's Organizer, similar to Windows Explorer, is an easy-to-use and dynamic tool for easy search and retrieval of documents. All SOPs and other documents related to a particular change can be grouped together. MasterControl's medical device change control systems allow users to create virtual folders within Organizers that will automatically retrieve documents based on pre-defined queries.

Powerful Reporting Tool:Data can be grouped together by a date interval and then charted over a date range. For example, the number of customer complaints that have led to a change can be totaled for each week and charted for the last year. Data can be summarized in multiple levels, so change orders can be reported by product, department, root cause, etc.

Sustained Compliance:Inadequate change control can lead to serious quality system violations and expose medical device manufacturing companies to product liability actions. MasterControl's medical device change control system solution is designed not only to help you attain FDA and ISO compliance but to sustain it year after year by interconnecting all quality subsystems, strengthening the change control procedure, fostering efficiency throughout the enterprise, and keeping compliance costs down. MasterControl offers comprehensive validation services, including protocols and consulting services. More importantly, MasterControl offers you something beyond software: a partnership that will support your compliance efforts in the long term.