Change Control Procedures

Change Control Procedures that Ensure Compliance and Enhance Productivity

In FDA-regulated and ISO-certified environments, change control procedures are required for assuring product quality and safety.

Given the multitude of ongoing processes for document change (for example, to design specs, formulations and SOPs, as well as specifications for raw materials, equipment, etc.), change control procedures that are automated is indispensable.

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Best Practice Form for Change Control Procedures

The change control procedures form by MasterControl provides an automated, pre-configured, multi-page best practice form for collecting and tracking data during the entire change control process, which includes submission, evaluation, approval/ rejection, implementation, verification, and close of project.

• A section in the change submission form captures such information as: description of change control procedures, justification, and impact. Both original and revised documents 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 in a component used in making 10 products can have 10 attachments, greatly streamlining the process.
• The change control procedures prompt 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 procedures 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 form can be customized to meet any unique requirements for change management that a company may have.

Additional features of Change Control Procedures Software

Other important features provided by the change control procedures software by MasterControl are outlined below.

• Form-to-Form Launching
• Dependent Routing
• Dynamic Organizers
• Powerful Reporting Tool

For More Information on Change Control Procedures

If you would like more information about the software from MasterControl for automating change control procedures, feel free to contact a MasterControl representative.