Change Control Software Systems

In FDA-regulated and ISO-certified environments, companies are expected to establish procedures for effective change control software systems in order to ensure product quality and safety. Regulated and ISO companies are also expected to maintain detailed documentation on all changes that are made in a change control software.

Given the multitude of ongoing processes for document change (design specs, formulations, SOPs, specifications for raw materials, etc.), automated change control systems are critical. Not only can software for change management assure compliance, it can also greatly enhance a company's productivity.


Watch Videos: Learn More About Change Control Software Systems

Download Free Change Control Software Systems Resources

Product Information

Discover how MasterControl Change Control Software Systems can manage your Change Control process, all while mitigating risk, improving speed-to-market, and generating ROI.

Product Data Sheets
Product Data Sheets
  • Change is the only constant in quality management, as in life. In FDA and ISO environments, the key is to manage the inevitable changes that occur for the sake of improving product quality and safety, and to ensure compliance. MasterControl Change Control automates every step of the change control process and keeps your quality system in a state of constant audit- and inspection-readiness.

Educational Materials

Get insider information about the most relevant issues in Change Control Software Systems today, and how to navigate and overcome the complexities of FDA and ISO compliance.

Product Data Sheets
White Papers


How can MasterControl Change Control Software Systems Benefit You?


MasterControl change control software is designed to help 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 with your current change control system.

Change Control System Challenges

MasterControl Change Control Software Solution


Disconnected Change Control System Processes

Communication breakdown is likely to happen in companies that rely on disparate tools and processes to manage the quality system. In the context of 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 Change Control Software

MasterControl is an integrated change control software 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 Change Control Turn-Around

Timelines are essential in change control systems. 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. implementation.

Excellent Turn-Around with a Change Control System

MasterControl integrates and streamlines the entire change control system procedures 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 Software

In a manual 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 for which MasterControl's Change control software was introducted.

Integrated Training System with Change Control System

With MasterControl, the change control software 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.


Change Control Software System Best Practice Form

The change control software system from MasterControl offers a pre-configured, multi-page best-practice form for collecting and tracking data throughout the entire change control process.

  • A section in the change form captures information such as: description of change, justification, and impact. Both original and revised documents can be attached for easy comparison.
  • The initiator of the change can use the same form for multiple changes. For example, the form for a change in a component used in making 10 products can have 10 attachments, greatly streamlining the process.
  • The change control software prompts the initiator to evaluate the change in terms of training requirements, validation, and regulatory requirements prompting risk assessment.
  • The initiator is also asked to classify the change as low, medium, and high. Any high-level change implies great impact on the product and is likely to require regulatory filing.
  • In addition, the change control software system prompts the initiator to categorize the change as routine, temporary or emergency. (A high-level change usually implies great impact on the product and is likely to require regulatory filing.)
  • The form for change management can be customized to meet any unique requirements.

Additional Change Control Software System Features

Other important features provided by the change control software system from MasterControl are outlined below.


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. MasterControl streamlines this process and maintains the links, making it easy to 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 – With the change control software from MasterControl, 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 begin their next task). An innovative dependency tree graphically illustrates the relationships between dependent processes.


Dynamic Organizers – The MasterControl Organizer, similar to Windows Explorer, is an easy-to-use and dynamic tool for finding and retrieving documents. All SOPs and other documents related to a particular change can be grouped together in the change control software. Users can create virtual folders within Organizers that will automatically retrieve documents based on pre-defined queries.


Powerful Reporting Tool – The change control software system can group data together by time interval, then chart the data for a specified range of dates. 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 at multiple levels, so that change orders can be reported on by product, department, root cause, etc.


For More Information on Document Control Software Systems

For additional details about the Document Control Software Systems from MasterControl, please feel free to contact a MasterControl representative.