The software from MasterControl for change control offers a pre-configured, multi-page "best practice" change form to help collect and track data during the entire process for change control (or change management control). The change form provides information about the submission of the request, evaluation, approval/ rejection, implementation, verification, possible validation and closure of a change.
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 management software is indispensable.
Watch Related Videos
Outlining the main points of change also serves as a good practice in analyzing and addressing the business areas that are eventually impacted by it. FDA and ISO regulatory bodies pay particular attention to companies' policies regarding implementation of changes. A change can be minor - impacting only a slight alteration in document - or a huge one that results in completely changing an entire process. All these changes must be carefully planned, which is why MasterControl provides automated change forms that simplify the process of capturing all essential information pertaining to the change, such as its point of initiation, requirements, source, etc. Therefore, MasterControl change forms allow organizations to add basic as well as advanced change information that in turn serves as the basis for analyzing, planning, and implementing such changes.
Any change implemented in the system must also be documented. The change forms provided by MasterControl allow users to document each step of the change in the system's knowledge bank that is available to all authorized users for reference. Since MasterControl locks a document during the updating process, it cancels out any chances of a user consulting an outdated version of the document.
MasterControl change forms also help in dividing a change into various stages so that each segment is properly planned and implemented.
MasterControl understands the need for change. It is obvious that a change comes in consequence to a customer complaint, a new business requirement, an audit observation, or a general market need that must be addressed without delay. Usually a change stresses a quick fix to an issue at hand. For this reason, a MasterControl change form can be launched directly from a corrective/preventive action (CAPA) form, connecting one process seamlessly to the next. An administrator can continually monitor the change and its impact with the help of links that allow users to review the completed process and see what triggered the change. Relevant information from the CAPA form is automatically entered into the change form. Examples of other related GxP processes include nonconformance, deviations, customer complaints, and audit software.
Conducting internal trainings to educate employees about changes to business processes and other aspects of the company are essential to the efficacy of the user education program. It is important to develop the training program so that employees are constantly kept up to date about any changes. MasterControl makes it possible to integrate change forms with training control. The system ensures that any change to a document or process that warrants new training automatically invokes new training tasks. This helps maintain continuous regulatory compliance and keeps your quality system perpetually ready for inspections and audits.
Contact a MasterControl representative to learn more about the information necessary on a change form, and how MasterControl can help with automated change management solutions.