Every organization should have its own change management solution procedure depending on what sort of industry you work in, what kinds of processes your organization operates daily, and what sorts of standards and regulations are applicable. However, it is especially important in manufacturing and healthcare industries with precise and regulated processes. A robust change control solution can link users and data via a centralized system and connect the change control process with other quality processes to boost continuous improvement.Ĭhange Management: Change management is an essential element of all organizations, a systematic process of enacting and tracking change within an organization. Enforcement of any new or updated Good Manufacturing Practice (GMP) documentation and appropriate staff trainingĪn integrated change control management can automate and streamline the entire change control process, from submission through resolution.Essential regulatory approvals for the changed state before the product made under the change is released in the market.A record of required elements of plan review combined with supporting data.A plan that identifies actions, inputs, outputs and control limits to determine successful achievement of the desired change. ![]() The important features of change control include: The control may be proactive or reactive, as a response to mitigate or eliminate the consequences of unplanned change, also known as deviation. What is the Change Control Management Plan?Ĭhange control management system refers to the controlled set of actions to ensure that a change does not negatively impact a product’s safety, quality or compliance.
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