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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White Paper: Change Control - Quality Improvements in FDA and ISO Environments
White Paper: Automating Electronic Engineering Change
White Paper: Managing Change Control to Comply with FDA and EU Regulations
White Paper: Six Ways to Optimize Your Quality Management System and Ensure FDA and ISO Compliance
Product Data Sheet: MasterControl Documents™
Product Data Sheet: MasterControl Change Control™
Tech Paper: MasterControl Change Control™


Document Configuration Management Problems

MasterControl Solutions for Configuration Management

Quality department bottle-neck situations.

MasterControl allows configuration management processes to be collaboratively documented from start to finish so that innovation isn't slowed down unnecessarily when innovative products are reviewed by the quality department.

Keeping track of ECNs (engineering change notices) and ECRs (engineering change requirements) often leads to misplaced documents or a lack of assurance that a document or drawing is a latest version document.

MasterControl keeps track of ECNs and ECRs and allows you to collaborate with your colleagues to create them. With MasterControl it's always clear which document version is the latest document version for better configuration management.

You have various types of files to manage and you don't have a configuration management system that will manage all of them.

MasterControl will manage all types of files to ensure effective and efficient configuration management. From drawings, to spreadsheets and word processing documents, MasterControl can keep all your engineering change management information current and under control.

Employee accountability isn't always easy to measure but it is now with MasterControl's Configuration management system.

MasterControl allows you to assign tasks, send out email notifications and take advantage of integrated task tracking, clarifying increased accountability expectations among employees.

How can you create with collaboration, track with assurance and document with accuracy without wasting valuable innovation time? Learn more about MasterControl document, change management, BOM and supplier solutions for improved configuration management.

How can MasterControl Configuration Management Benefit You?

MasterControl Documents, an integrated part of the MasterControl quality management suite, automates electronic document management processes in an efficient and cost-effective manner. Here are some of the features and benefits of implementing an electronic configuration management software solution:

  • Revision Control: MasterControl provides automatic configuration management for document revision control to ensure that only the current version of a standard operating procedure SOP is available. When a user makes a change in the InfoCard (the MasterControl tool that provides basic information for every electronic document), the user must enter a reason for the change. The software tracks all changes made to the InfoCard.
  • Solid Audit Trail: Configuration management system also provides a secure, time-stamped audit trail exceeding 21 CFR part 11 requirements. MasterControl documents the identity of anyone who creates or modifies an electronic record, when the action occurred, and the changes made.
  • Security: 21 CFR Part 11 emphasizes security practices that limit access to authorized users and holding them accountable for written policies. With MasterControl, an electronic document is stored in virtual vaults located in a central database for access by authorized users only. The monfiguration management software automatically locks both login and approval anytime either one is compromised.
  • Advanced Tracking: MasterControl's electronic configuration management system tracks documents by status or history. A document will show as either "in process" or "complete" if tracked by status. The revision or approval history of electronic documents can also be reviewed using the history feature.
  • Analytics and Reporting: MasterControl's electronic document management system uses advanced analytics and reporting capabilities in the form of standard and customized reports to help increase management oversight.
  • Electronic Sign-offs: With MasterControl, electronic documents can be signed and approved in an automated fashion. Electronic signature manifestation — name, date, time, and meaning of electronic signature — can be appended automatically to each document.
  • Manage Different Document Types: MasterControl's electronic configuration management system is uniquely qualified to be the focal point of any compliance initiative because it can manage different documents-based processes and handle all types of electronic documents regardless of the software used to create them.

For More Information About Configuration Management

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


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