Configuration Management


Learn How to Automate Document Control / Configuration Management Processes to Comply with FDA Regulations and ISO Standards

Supporting configuration management and the automation of engineering change control process for engineering documents is critical during a product's lifecycle. For instance, it has been estimated that an engineering part may undergo approximately ten engineering changes throughout its lifecycle. Now consider a complex product that could possibly require a company to process thousands of engineering changes for just that one product. Learn more about configuration management and engineering change control.

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Product Data Sheet: MasterControl Documents™
Product Data Sheet: MasterControl Change Control™


Resolving Document Configuration Problems with MasterControl Configuration Management Software

Quality control and quality assurance departments play a vital role in reviewing the changes made to existing processes and products. Accordingly, it is vital that all the various stakeholders have a collaboration workspace that allows them to effectively document configuration management processes. To help companies avoid bottlenecks in quality processes, MasterControl provides a configuration management software solution that streamlines quality systems.

Engineering change notes are drafted with the input of several stakeholders. This documentation typically serves as the basis for planning, developing, and eventually implementing changes to products and processes. As such, it is essential to develop an active line of communication for drafting this documentation. Engineering change notes must also be promptly reviewed and approved by all concerned parties. Any delay in the approval lifecycle means that there will also be a delay in distributing updates to standard operating procedures throughout the enterprise. The company then runs the risk of allowing employees to work off outdated documentation. The MasterControl configuration management software solution includes a revision control feature that ensures that users are only referencing the latest document. The system also incorporates rapid automatic routing and escalation features for documents requiring approval which also reduces approval lifecycles.

Unlike paper-based or legacy configuration management systems, the MasterControl solution guarantees traceability and user accountability because it is able to effectively track the progress of tasks assigned to employees. MasterControl's configuration management solution sends out email notifications and automates task tracking, which clarifies increased accountability expectations among employees.

Attaining and Sustaining Compliance with MasterControl Configuration Management Software

The MasterControl configuration management solution helps enforce regulatory standards by eliminating configuration drift. In an effort to continually comply with FDA, ISO and CGxP regulations, our software provides access to authorized users and holds them accountable for written policies. The system provides time-stamped audit trails that meet CFR Part 11 requirements. In accordance with regulatory requirements, electronic documents are stored in virtual vaults located in a central database accessible only by authorized users. MasterControl configuration management software also comes complete with built-in advanced reporting and analytics tools that are vital to maintaining compliance and ensuring efficient configuration management. These reporting tools help users generate a variety of customizable and standard reports that are critical to the establishment of compliant practices.

For More Information About Configuration Management

For more information in regards to MasterControl configuration management solutions, please feel free to contact a MasterControl representative.