All companies, regardless of industry, must implement an effective change order system in order to meet consumers' increasing demands for higher-quality products at lower prices. In FDA and ISO environments, change control is an essential component to improving product quality and safety, as well as reducing noncompliance risk.
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MasterControl's change order software system is designed to automate and effectively manage every step of the change control process and ease the major challenges associated with change control. What's more, an electronic change order solution from MasterControl allows you to connect your organization's change control process with other quality processes across the enterprise to ensure not only continuous compliance and product improvement, but also reduced costs.
In the manufacturing environment, change refers to any modification in materials, facilities, utilities, product design, formulations, processes, packing/labeling, equipment, computer systems, as well as all associated documentation (SOPs, test methods, quality manual, etc.). A change order software system may be called upon to handle a relatively minor adjustment, such as a part replacement, or it may be expected to address an issue that is serious enough to shut down production. In a large or growing company, it would be very difficult, if not impossible, to manage change and demonstrate compliance without an enterprise-wide change order system.
While the regulatory requirements for change control differ by industry, the underlying message is that changes should be made in accordance with approved written company policies and procedures. The reason for this is two-fold: written policy allows for the standardization of procedures, and it is also more reliable than simply passing on information verbally. Additionally, it allows organizations to maintain a history of all changes associated with the particular item or entity being changed, which is crucial for auditing purposes.
MasterControl's change order software is robust and flexible enough to manage all types of change requests that could affect the safety and reliability of products and directly impact public health and safety. And because even the smallest change can make a big difference in your bottom line, an effective change order system is essential if your organization hopes to remain profitable and competitive.
While an electronic change control system is necessary to prevent the occurrence of inappropriate or "uncontrolled" change, which in this context refers to modifications made without the proper review and approval of the quality control unit and other departments impacted by the change, implementing and maintain one can be quite complex. Fortunately, MasterControl's change order software system was designed to handle these challenges quickly and efficiently. Here's how:
An Explorer Tool for Easy Document Search and Retrieval: Similar to Windows Explorer, MasterControl's Explorer allows you to quickly and easily find and retrieve documents. Explorers also allow you to group together SOPs and other documentation related to a particular change. What's more, within Explorers, users are able to create virtual folders, which allows for the retrieval of documents based on pre-defined queries.
Part 11-Compliant Features: MasterControl change order software provides a time-stamped audit trail, reporting, and electronic signature capabilities that fully satisfy FDA's 21 CFR Part 11 requirements. The identity of anyone who creates or modifies an electronic record is tracked in the audit trail, as well as when and what changes were made. Robust security features, such as dual passwords for document approval; password expiration, encryption, and certification; and account lockout, prohibit users without proper authorization for gaining access to the system.
Continuous Validation: Validation is a critical component of any change order software system. MasterControl offers a wide range of validation products and services, such as MasterControl Transfer OQ and MasterControl Automated OQ. These products and services are designed to meet various need levels based on risk, and offer "continuous validation" to FDA-regulated companies. The bottom line: Continuous validation dramatically makes software upgrades easier, faster, and more cost-effective.
For more information about MasterControl's change order software system, and how MasterControl can help your company, please feel free to contact a MasterControl representative.