Change Control Plan

Change control plan software for change control assures compliance and enhances productivity

Given the multitude of ongoing processes for document change (involving design specs, formulations, SOPs, raw materials specs, equipment specs, etc.), regulated companies (or those seeking ISO certification) are expected to establish a change control plan as a way of assuring product quality and safety. In addition, detailed documentation must be readily available.

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Important Elements of a Change Control Plan

The change management software from MasterControl provides a change form that is pre-configured for collecting and tracking data during the entire change control planning process. The multipage form prompts users to enter the change request, as well as data pertaining to its evaluation, approval/ rejection, implementation, verification, and close of the process for change management.

The change submission form is thus an important element of the change control plan. Details are summarized below:

• A section in the change submission form captures such information as: description of change, justification, and impact. Both original and revised documents of the change control plan can be attached for easy comparison.
• An initiator can use one form for multiple changes, depending on how many documents/items are affected by a change. For example, the form for a change control plan in a component used in making 10 products can have 10 attachments, greatly streamlining the process. This is one way a change control plan can enhance productivity.
• The change control plan software prompts the initiator to evaluate the change in terms of training requirements, validation, and regulatory requirements prompting risk assessment.
• The initiator is also asked to classify the change as low, medium, and high. Any high-level change implies great impact on the product and is likely to require regulatory filing.
• In addition, the change control plan software prompts the initiator to categorize the change as routine, temporary or emergency. (Any high-level change implies great impact on the product and is likely to require regulatory filing.)
• The change management form can be customized to meet any unique requirements of a change control plan.

For More Information on Change Control Plans

For more information about the requirements for a change control plan, or about MasterControl, please feel free to contact a MasterControl representative.