Given the multitude of ongoing processes for document change (involving design specs, formulations, SOPs, raw materials specs, equipment specs, etc.), regulated companies (or those seeking ISO certification) are expected to establish a change control plan as a way of assuring product quality and safety. In addition, detailed documentation must be readily available.
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Any potential change to an existing business process must have a strong justification behind it. As there is a high cost in approving and implementing a change, it is important to carefully plan and allocate resources. Obtaining an appropriate level of approval for changes requires the engagement of various employees from different departments. This means the scope of change itself illustrates the impact, detail, and planning behind its implementation. Legacy change control plan tools lack the intuitiveness and specificity to properly address changes that cause problems. With the development of change control plan software tools, it has become much easier for companies to measure, define, and control the changes that are eventually applied across the enterprise.
In efforts to continuously improve their businesses, MasterControl provides companies change control plan software that helps top-level management and business executives to plan change in accordance with their specific business requirements. MasterControl solutions help companies develop a thorough change control plan that is effective and addresses all the basic and advanced needs of the business. MasterControl change control plan software is designed to allow companies to quickly approve changes while maintaining a clear record of changes made to existing sets of processes in the system.
MasterControl change control plan software accommodates various elements of change through a pre-configured change form. In order to maintain an accurate detail of a change, this form facilitates the collection and tracking of data during the entire change control planning process. The multi-page form is further used for evaluation, approval/ rejection, implementation, verification, and close of the project. The change control plan form offered by MasterControl is partitioned into several sections that help improve the manageability of change requests and their translations so that a change can be easily planned for and implemented within the business. One section of the change submission form captures detailed information regarding the change such as its justification and impact. The form also allows for attachments, which makes it easy for users to distinguish between older and revised documents.
An initiator can use the same form for multiple changes, depending on how many documents/items are affected by a change, which increases the re-usability of data and decreases the duplication of effort. Since multiple products can have multiple attachments, the process is streamlined even further. In addition, MasterControl change control plan software enhances productivity by giving initiators automatic prompts to evaluate a change in terms of its scope, training requirements, and regulatory obligations.
Any change incorporated in a business process is prone to risk. This is why it is important to evaluate the change and specify the level of its impact as low, medium, or high as well as the estimated scope of the impact. In most cases, the level of impact underlines the amount of regulatory filing required for the change. MasterControl change control plan software allows management to better align their business processes with the regulations associated with their industries which ultimately helps in sustaining compliance.
Similarly, companies can also base their training programs on MasterControl's proven change control plan software solution. Any change that is accurately documented consists of a lot of information in the form of viable documents available in the company's knowledge bank. Those same documents can be used by management to educate the employees about the changes made in the processes. MasterControl connects training protocols with the appropriate documentation to ensure that training is conducted appropriately and within regulatory specifications.
For more information about the requirements for a change control plan, or about MasterControl, please feel free to contact a MasterControl representative.