Document Change Control

Document change control software for managing document change assures compliance and greatly enhances productivity

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

Given the multitude of ongoing changes in the form of design specs, formulations and SOPs, as well as raw materials, equipment, etc., document change control software is indispensable.

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Best practice form for Document Change Control

The document change control software from MasterControl offers a change form that automates the entire process for change management.

The pre-configured, multi-page best practice form helps to collect and track data throughout the document change control process, which includes submission, evaluation, approval/ rejection, implementation, verification, possible validation and close of project.

The change submission form captures information such as: description of change, 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 the document change control is in a component used in making 10 products can have 10 attachments, greatly streamlining the process.

The solution for the document change control 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 document 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 document change control software can be customized to meet a company's unique requirements.

Other key features of Document Change Control Software

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

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

Document Approval via Forms: With the software from MasterControl for document change the change submission form and the documents that are linked to it can be approved all at once, avoiding repetitive steps.

Dependent Routing: Completion of a given 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 document change control processes.

Dynamic Organizers: MasterControl's Organizer (similar to the Windows Explorer), is an easy-to-use and dynamic tool for quickly locating and retrieving documents. All SOPs and other documents related to a particular change can be grouped together. Virtual folders can also be created within Organizers for automatically retrieve documents based on pre-defined queries.

Robust Reporting Tool: The application for document 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 led to a change can be calculated for each week and charted for the last year. Data can be summarized at multiple levels. This enables change orders to be reported on by product, department, root cause, etc.

For More Information on Document Change Control

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