Change Control

Given the multitude of processes for document change that affect design specs, formulations, raw materials, SOPs, etc., change management software is indispensable.

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Best practice form
The software for change control from MasterControl provides a pre-configured, multi-page “best practice” form to help collect and track data during the change control process, which includes submission, evaluation, approval/ rejection, implementation, verification, possible validation and close of project.

• A section in the change submission form captures such information as: description of change, 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 solution for change control 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 application for change control 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 software allows users to customize the change form to meet a company's unique requirements.

Other Important Features
Other important features provided by the MasterControl application for change control are outlined below.

Form-to-Form Launching – A change submission form can be launched directly from a Corrective Action /Preventive Action (CAPA) form, connecting one process to the next. MasterControl streamlines this process and maintains the links, making it easy to see what triggered the change. Relevant information from the CAPA form will be automatically entered into the change submission form, reducing data entry. The software for change control will show the history of the entire process.

Document Approval via Forms – with the software from MasterControl for change control, the change submission form and the documents linked to it can be approved all at once, avoiding repetitive steps.

Dependent Routing – Completion of a task can be made dependent on another task to give managers more control and reduce cycle time (by prompting users immediately to perform their next task). An innovative dependency tree graphically illustrates the relationships between dependent processes.

Dynamic Organizers – MasterControl's Organizer, similar to Windows Explorer, is an easy-to-use and dynamic tool for finding and retrieving documents. All SOPs and other documents related to a particular change can be grouped together. Users can create virtual folders within Organizers that will automatically retrieve documents based on pre-defined queries.

Powerful Reporting Tool – The application for change control can group data together by time interval, then chart the data for a specified range of dates. For example, the number of customer complaints that have led to a change can be totaled for each week and charted for the last year. Data can be summarized at multiple levels, enabling change orders to be reported on by product, department, root cause, etc.

For More Information
For more information about the software for change control from MasterControl, please feel free to contact a MasterControl representative.