Change Order

Learn How to Use Software to Automate Your Paper-based Change Order System / Change Control System

Every manufacturer needs a change order process for initiating and controlling any modifications in a SOP, drawing, part, process, or equipment. The change order process is crucial in ensuring high quality, safety, and consistency of products. For this reason, change control is key to compliance in the FDA and ISO environments.

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White Paper Features: Automating an Electronic Engineering Change Order Management System White Paper

This white paper discusses key functions of an engineering change order process, common concerns of manufacturers regarding the process, and the advantages of an automated ECO system. It describes:

• A typical engineering change order process and its common functions
• Issues in controlling change
• Advantages of Web-based system
• Glossary of engineering terms and acronyms

The white paper also discusses the MasterControl quality management software solution, which offers a holistic approach to improving change order management and maintaining efficiency throughout an organization.

How can MasterControl Change Order Software Benefit You?

MasterControl Change Control is designed to help ISO and FDA-regulated manufacturers automate and effectively manage every step of the change order process, from submission through actual implementation, verification, and close of project. Here are some of the features and benefits:

• Increased Efficiency Through Automation: MasterControl software automates all tasks pertaining to change control, including notification, follow-up, and escalation of overdue assignments. Automation helps simplify the compliance environment, making the change order process easier to stay compliant.

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

• Analytics and Reporting: MasterControl's advanced analytics and reporting capability increases management oversight. It provides the ability to dynamically capture, trend, and link data needed to solve problems and improve processes. Change order data can be summarized in multiple levels, so change orders can be reported by product, department, root cause, etc.

• Revision Control: While the current document is still available to the intended audience, authorized users may check-out and collaborate with others to make revisions to draft documents. Upon completion, the change order functionality automatically sends the updated copy through an approval route, impacted users are trained on changes, and the newly approved version bumps the obsolete document to archive status where retention rules come into effect.

• Easy Access: MasterControl Change Control is web-based so it can connect employees, suppliers, contractors, consultants, and others involved in the change order / change control process regardless of location.

• Form-to-Form Launching: A change order form can be launched directly from another form, such as a corrective/preventive action (CAPA) form. Pertinent information from the CAPA form will be automatically entered into the change submission, reducing data entry. Links are maintained so users can review a complete change order process and see what triggered the change.

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

• Electronic sign-offs: With MasterControl, you can get approval from different people without the legwork. Documents can be signed and approved electronically. Signature manifestation, name, date, time, and meaning of electronic signature can be appended automatically to each document from the change order system.

• Integrates with Other Applications: MasterControl's change order solutions can integrate with other applications like ERP, LIMS, accounting, and human resources applications to accommodate departmental needs.

• Easy to Search: A standardized Google-like search window is available throughout the application, which means all authorized users throughout the organization can search and retrieve change control-related tasks and documents.

• Easy to Find: MasterControl's Organizer, similar to Windows Explorer, is an easy-to-use tool that helps users find and access change order documents and information quickly. Every department can maintain its own Organizers and documents can be stored in multiple Organizers. System administrators can control and automatically update the documents through a dynamic link in the InfoCard.

• Automation of Forms-Based Processes: Any forms-based process unique to a department (i.e., application forms for HR, customer satisfaction survey forms for Customer Service Department) can be automated to synchronize the change order. A department can keep the look and function of existing forms or create entirely new ones.

How can MasterControl's Change Order Software Ensure Compliance with ISO and FDA CGxP Requirements?

Compliance with federal regulations and adherence to international quality standards is part of doing business for most industries. MasterControl's change order software ensure regulations and standards existence to protect consumers and the public in general. They are a major driving force for companies to manufacture and sell products (or provide services) that are safe, reliable, and effective.

Since 1993, hundreds of companies in a wide range of regulated industries have relied on the MasterControl integrated quality management suite to attain and sustain compliance with regulations and standards:

MasterControl's Change Order Software Complies with Sub Part F, Section 21 CFR Part 211.100 a b

There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport to possess. These written change order procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit. Written production and process control procedures shall be followed in the execution and shall be documented at the time of performance. Any deviation from the written procedures shall be recorded and justified.

MasterControl Change Order Software Complies with ISO 9000:2000 Clause 7.3

Design and development: Requirements include establishing a change order system to identify, document, and control design changes.

For More Information on Change Orders

Contact a MasterControl representative to learn more about the change order software that we offer, as well as the requirements for a change orders.