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.
Sélectionnez toutes les ressources que vous souhaitez télécharger.
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.
Keeping up with modern business trends, companies are now drifting towards automated document change control software that allows users to enter and access data quickly. Paper-based solutions don't aid management in controlling forms that ensure the entered data is accurate. The problem becomes greater when the same data has to be transferred to different forms for analysis. Instead of manually transferring data, MasterControl document change control software provides an automated form-to-form launching feature. This feature allows a change submission form, for example, to be directly launched from a CAPA form, connecting one process seamlessly to the next. Because the MasterControl system maintains links, the entire document change control process is completely streamlined, enabling users to see what triggered a change. Data may be entered only once through one form but will automatically be available in other relevant locations. The software for document change control also shows the history of the entire process.
MasterControl document change control software provides the facility of approving documents through forms. As all documents pertaining to a form are attached to it, the approval of a form also implies that the documents linked to it are automatically approved. This is a time-saving feature for approving supplementary documents that no longer have to go through the approval lifecycle.
Similarly, the status of a task can be made dependent upon another task's completion. This incorporates the concept of parent-child hierarchy in tasks within the system, which implies that if a parent task is completed it means that all the child tasks under the parent should also be closed. Instead of manually closing all tasks, the MasterControl document change control system allows for the completion of all tasks that are dependent on each other. The relationship between dependent document change control processes can be viewed with the help of a dynamic graphical tree.
MasterControl document change control software enhances the user experience by providing easy search and retrieval capabilities. MasterControl's unique Explorers are tools that allow documents to be easily located and retrieved. Pre-defined queries help users retrieve documents without any hassle. Similar types of documents can be grouped together with the help of virtual folders that also provide various departments with the ability to segregate their data.
Reports help management to gather statistics and deduce results that eventually shape the company's business. MasterControl's document change control software provides robust reporting tools that 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.
If you would like more information about the software from MasterControl for document change control, feel free to contact a MasterControl representative.