Every manufacturer needs an engineering change order process for initiating and controlling any modifications in a drawing, part, process, or equipment. The ECO process is crucial in ensuring high quality, safety, and consistency of products. For this reason, ECO is key to compliance In the FDA and ISO environments.
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By effectively managing engineering change orders (ECOs), an organization can gain a higher level view of the impact and scope of changes to business processes. The primary intent of an ECO is to outline the processes, product parts, or specifications that are affected by a change. Change requests and approvals from the individuals who impacted by or charged with implementing the change are also significant factors. MasterControl's engineering change order software is specifically designed to aid in constructing a thorough ECO that allows organizations to effectively manage the processes involved in making modifications to components, assemblies, associated documentation, and other types of product information (i.e., work instructions or standard operating procedures).
With so much relying on a single engineering change order, it is extremely crucial to invest the proper time and resources on its development and approval. MasterControl's ECO software allows companies to thoroughly manage engineering change orders from beginning to end and to summarize the modifications, finalize details, and obtain all necessary approvals. The MasterControl engineering change order software system guarantees manufacturing groups will receive a thorough and complete ECO document that provides a detailed description of each aspect of the implemented changes.
Modern business trends emphasize the automation of quality processes so that less human intervention is required to perform tasks. Accordingly, MasterControl's engineering change order software solution provides pre-configured, multi-page forms to collect and track data for all stages of the change control process including submission, evaluation, approval/ rejection, implementation, verification, and close of project. These forms are very useful in connecting various quality processes together. For example, the data fed into a change submission form can be set up to transfer automatically to a CAPA form. The automatic entry of same data into several forms helps eliminate potential errors that typically occur with manual data entry.
In order to ensure that ECO documents can be quickly approved, MasterControl provides rapid search and retrieval functionality. The document approval lifecycle is streamlined with the help of electronic sign-offs so that if a document is pending approval it will be automatically escalated after a predetermined period of time. This facility helps in speeding up reviews and approval processes so that the engineering change order is readily available to all authorized users in the fastest possible time.
The system's advanced analytics and reporting capability is useful in dynamically capturing, trending, and linking data needed to solve problems and improve ECO processes. This invariably increases management oversight as data can be summarized in multiple levels, so change orders can be reported by product, department, root cause, etc. Management can then make important business decisions on the basis of reports that have been generated on a timely basis as per business requirements.
Adherence to FDA and ISO cGxP standards is critical and is just part of doing business for most industries. MasterControl's engineering change order software solution ensures compliance with these international quality standards. Regulations and standards exist 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:
The engineering change order software available from MasterControl is designed to aid manufacturers in adhering with FDA and ISO regulations by providing the platform to develop a compliant engineering change order document. By allowing them to effectively utilize authenticated information about proposed and implemented changes, businesses are able to operate more efficiently. All authorized users can refer to these documents for enacting standard operating procedures without any deviance or nonconformance from the written standards. These documents are also useful in building a comprehensive training program for educating users about the newly introduced changes in the business.
Find more information on engineering change orders (ECO), visit MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.