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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Shrewdly anticipating and addressing changing business needs is the foremost objective of any successful company. Top level- management faces many new and ongoing issues while implementing changes to systems. To help meet these needs MasterControl provides change order software that is entirely web-based to aid users during every phase of the change order process. An automated change order system provides easy access to all data and documents to authorized users and also allows them to search for and retrieve documents without any hassle. Compliant with ISO and FDA regulations, MasterControl change order software is designed to ensure smooth implementation of change and lets users segment each step of the change process including submission through actual implementation, verification, and close of project.
Automation allows system users to manage change control tasks (i.e., notification, follow-up, and escalation of overdue assignments) with minimum human intervention or error. The size and scope of a change highlights its magnitude, associated risks, and impact on the business. Moreover, it also illustrates the amount of documentation required along with the change. It is important to continuously update documents to reflect the actual implementation of standard operating procedures in the system. MasterControl change order software streamlines the entire documentation lifecycle for prompt approval of documents.
Practically speaking, change control processes should always be integrated with various sources to ensure that all relevant information pertaining to a change is securely captured from the very point of initiation. With form-to-form automation, MasterControl change order software integrates change control with CAPA systems. This integration ensures that all the basic and advanced information related to the change is automatically entered into a CAPA form without the need of any manual data entry. The end result is flawless data capture without wasted time or extensive resource dedication.
The evaluation of pertinent business statistics is essential to a company's growth. Particularly in times when the belt has to be tight, it is important to carefully plan changes that will have an impact on the company's reputation and standing in the market. MasterControl change order software helps companies manage their business processes by effectively handling changes that are well-planned and implemented in accordance to the latest industry standards and best practices. In order to increase management oversight, MasterControl change order software provides advanced analytics and reporting capabilities. All change data is dynamically captured and linked to solve issues which eventually improves the overall quality of processes. Change order data can be summarized in multiple levels as well, so change orders can be reported by product, department, root cause, etc.
Compliance with federal regulations and adherence to international quality standards is part of doing business for most industries in regulatory environments. Globally recognized standards are a major driving force for companies to manufacture and sell products (or provide services) that are safe, reliable, and effective. MasterControl's change order software ensures adherence to regulations and standards in order to help businesses thrive and to protect consumers and the public in general.
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.
According to FDA guidelines, 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. The MasterControl change order solution ensures compliance with these directives.
MasterControl allows customers to meet design and development regulations. Requirements include establishing a change order system to identify, document, and control design changes.
Contact a MasterControl representative to learn more about the change order software that we offer, as well as the requirements for a change orders.