Change Control Management

Software for Change Control Management Increases Productivity

In FDA-regulated and ISO environments, companies are expected to establish procedures for change control management as a way of assuring product quality and safety. In addition, detailed documentation about the change must be readily available.

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 management software is indispensable.

Watch Videos How MasterControl Makes Your Job Easier (3:50) Creating a Paperless Process Using MasterControl (3:38) Saving Time with MasterControl (3:29)

Best Change Control Management Practice Form

The change control management software from MasterControl offers a change form for automating the entire process for change management. The pre-configured, multi-page, best practice form helps collect and track data throughout the change process, which includes submission of the change order, evaluation, approval/ rejection, implementation, verification, possible validation and close of project.

• The submission form for the change captures information such as: change description, justification, and impact. Both original and revised documents can be attached to the form for easy comparison.
• The person initiating the change 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 management in a component used in making 10 products can have 10 attachments, greatly streamlining the process.
• The solution for change control management prompts the initiator to evaluate the change in terms of training requirements, validation, and regulatory requirements.
• The initiator is also asked to classify the change as low, medium, and high. A high-level change implies great impact on any product changed and is likely to require regulatory filing.
• In addition, the application for change control management 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 control management form can be customized to meet a company's unique requirements.

Other key features of Change Control Management

Other key features provided by the MasterControl application for change control management are listed below.

Form-to-form launching: Enables users (for example) to launch a change submission form from a CAPA.

Dependent Routing: Makes the beginning of one task dependent on the completion of another to reduce cycle time.

Dynamic Organizers: MasterControl's Organizer (similar to Windows Explorer) is an easy-to-use tool for quickly locating and retrieving documents.

Document Approval via Forms: With the software from MasterControl for change control management, the change submission form and the documents linked to it can be approved at the same time to avoid repetitive steps.

Dynamic Reporting Tool: Enables data to be grouped together by date and charted. Data can be summarized at multiple levels for example, by product, department, root case, etc.

For More Information About Change Control Management

If you'd like more information about change control management from MasterControl, please feel free to contact a MasterControl representative.