Change Control Project Management

Software for change control project management expedites productivity

All FDA-regulated and ISO companies are expected to establish procedures for change control project management as a way of assuring product quality and safety. As part of this requirement, detailed documentation about a 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.), software for change control project management 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 Project Management Practice

Software from MasterControl can help with change control project management. The software offers a change form that is pre-configured to meet all requirements for the best practice collecdtion and tracking data during the process for change management-- including submission of the requisition, evaluation, approval/ rejection, implementation, verification, possible validation and close of project.

• The submission form for the change control project management 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 in a component used in making 10 products can have 10 attachments; thereby greatly streamlining the process.
• The process for change control project management will prompt 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 changes suggest great impact on any product that is changed, and is likely to require regulatory filing.
• In addition, the process for change control project management will prompt the initiator to categorize the change as routine, temporary or emergency. (A high-level change implies great impact on a product and is likely to require regulatory filing.)
• The change management form can be customized to meet a company's unique requirements.

Other Key Features of Change Control Project Management

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: With the software from MasterControl for change control project 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:Change control project management software 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 on Change Control Project Management

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