All FDA-regulated and ISO companies are expected to establish procedures for change control project management as a way of assuring product quality and safety. As part of this requirement, detailed documentation about a change must be readily available.
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.), software for change control project management is indispensable.
Wählen Sie alle Ressourcen aus, die Sie herunterladen möchten
Changes in processes, procedures, and business practices are inevitable. It is important to effectively manage such changes by appropriately responding to feedback from various sources including customers, vendors, internal requirements, or issues raised during an audit. There are a variety of change control project management software solutions available on the market to help companies implement change in their business. However, most solutions don't assure thorough implementation of change across the enterprise. MasterControl software provides the features necessary for effective change planning by allowing management to automate the change control process with the help of pre-configured best practice forms.
To meet basic as well as advanced company requirements, MasterControl forms help in capturing all the essential information relating to a change such as its description, impact, and justification. The forms also allow for the attachment of documents which is helpful when comparing the changes in documents and expedites approval. With MasterControl change control project management software, a change submission form and the documents linked to it can all be approved at the same time, thereby avoiding repetitive steps.
Just like change is initiated through different sources, the data pertaining to change is also collected through several sources. Thoroughly tracking data in the change control process helps in better management of the change control process. MasterControl change control project management software defines each stage of the change control process for better operability during each of the stages. These stages include requisition, evaluation, approval/ rejection, implementation, verification, possible validation, and close of project.
MasterControl also integrates the change control process with CAPA processes, which ensures that alteration can be made to a process as soon as an issue is identified. Similarly, MasterControl change control project management allows a change submission form to be automatically launched from a CAPA. To enable prompt approval of tasks, a task's completion can be made dependent on the completion of another. So, instead of manually approving and closing tasks, managers can rely on MasterControl software to save valuable time during task approvals. MasterControl's powerful Explorer tools help in tracking documents without any hassle and simplify the task of searching for and retrieving documents.
Each change introduced in the system implies that a certain element of risk is associated with it. Some changes impact a very small part in the company's business, such as a minor alteration in an existing process, whereas other changes may have a huge impact and be indicative that a major alteration in or revision to an existing standard operating procedure is necessary due to the change. The scope or impact of the change identifies the level of risk and should either be classified as low, medium, or high. This classification establishes the type of regulatory filing required for documenting the change. The initiator of the change can use the same change control form for multiple changes, depending on how many documents/items are affected by a change. For example, the form for a change in a component used in making 10 products can have 10 attachments, thereby greatly streamlining the process.
The MasterControl change control project management solution prompts the initiator to categorize the change as routine, temporary, or emergency. This in turn helps management to establish protocol lines for dealing with the change across the enterprise. MasterControl software is completely customizable, allowing managers to adjust the change control project management execution in accordance to business requirements. It is also vital to have a comprehensive view of the statistical data pertaining to the changes introduced in the system. MasterControl software gives users the ability to generate various types of reports with chartable data grouped together or summarized at multiple levels such as by date, product, department, or root cause.
If you'd like more information about change control project management (or change management software) from MasterControl, please feel free to contact MasterControl.