In FDA-regulated and ISO-certified environments, change control procedures are required for assuring product quality and safety.
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.), automated change control procedures are indispensable.
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Effective management of the change control process is vital if an organization is to have smooth implementation of changes over time. Irrespective of a company's size or scale, change to existing sets of processes is inevitable. It is important to manage changes that are initiated through various sources such as customers, vendors, auditors, or other stakeholders in the company's system. A number of change control software tools are available on the market but are typically basic and incapable of catering to the business-specific needs of most companies. MasterControl change control procedures software stands apart from its competition by providing companies a platform for addressing their change control needs in accordance with their specific business needs. Regardless of the company's size, MasterControl software ensures compliance with regulatory policies so that the business can maintain compliance while staying competitive.
In addition to effective change control procedures, it is also vital that an organization has a thorough understanding of various critical elements of the change control process. Accurate and accessible documentation pertaining to the change control process, for instance, is the foundation of effective change control procedures. Any change initiated must be documented from the very beginning. This ensures that data related to the change is recorded and traceable, which ultimately helps in properly planning, analyzing, and implementing changes within the system. MasterControl change control procedures software provides an online platform that allows different types of users to access change-related documentation from any virtually any location around the world. This facilitates users' ability to collaborate and exchange ideas and information that ultimately culminate in the documentation of each and every minute detail in a secure online repository.
The key to flawless change control procedures is automation. For this very reason, MasterControl provides change control procedures forms that are completely automated. The form is pre-configured to be used as is, but may also be customized to allow management only to use it as per their unique requirements for change management.
These multi-page best practice forms help users collect and track data during the entire change control process. This is a particularly useful feature as change control is an intricate process that requires constant monitoring through the various stages involved. The elaborate MasterControl change control procedures software system is comprised of all the necessary change control components, specifically submission, evaluation, approval/ rejection, implementation, verification, and close of project in order to completely capture all relevant details pertaining to a change. A special section in the form is specifically available to capture such information as description of change control procedures, justification, and impact. Both original and revised documents can be attached for easy comparison. Because filling out multiple forms for similar kinds of changes can be tedious and time-consuming task, MasterControl allows initiators to use a single form for multiple changes, depending on how many documents/items are affected by a change. For example, a form for a change in a component used in making 10 products can have 10 attachments, which can greatly streamline the process. A change is classified by its level of impact in the MasterControl change control procedures system. It can either be classified as low, medium, or high. Depending on the impact, the initiator can then evaluate the change in terms of training requirements, validation, and regulatory requirements prompting risk assessment.
For better management of change, MasterControl change control procedures software incorporates form-to-form launching that integrates several functionalities together. Since CAPA is integrated with the change control process, the data entered through a change control form is automatically entered into a CAPA form as well. This also minimizes duplicated efforts by eliminating multiple entry of the same data in the system. The data residing in forms can be easily managed with the help of dynamic organizers that are specific to each department. This facilitates data transparency that enables data traceability and security within the organization.
MasterControl change control procedures software is further equipped with robust reporting tools that help generate different useful reports. Each report displays data that highlights various statistics that empower management to base their decisions and develop sound business plans on accurate and dependable analytics.
If you would like more information about the software from MasterControl for automating change control procedures, feel free to contact a MasterControl representative.