In FDA-regulated and ISO environments, companies are expected to establish procedures for change control management as a way of assuring product quality and safety. In addition, detailed documentation about the 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.), change control management software is indispensable.
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Management of the entire change control process ensures that any alteration in the existing set of procedures is properly implemented throughout the enterprise. However, paper-based or hybrid change control management systems lack the tools required to effectively manage and implement change. Utilizing such inefficient systems inevitably leads to data loss, lack of collaboration, and disharmony in processes, people, and the organization overall. To counteract these inefficiencies, MasterControl provides best practice change control management forms that are completely web based. The entire change control management process is automated and streamlined with the help of pre-configured, multi-page, best practice forms.
An important constituent of change control management software is the capacity to collect and track data through different sources such as customer requests, audit findings, management specifications, and so forth. To accommodate these factors in initiating a change, MasterControl allows form-to-form launching. For example, a change submission form can be directly launched from a CAPA.
It is crucial to collect all information related to a change in a centrally accessible location. The MasterControl change control management solution captures information such as change description, justification, and impact. To facilitate the comparison of changes that have been made to documentation, both original and revised documents can be attached to a form. Similarly, the software enables quick approval of documents that are linked with the change submission form. Instead of repeating the document approval cycle, the document attached with the form can also be approved the same time.
The MasterControl change control management process is elaborate and divided in several stages including submission of the change order, evaluation, approval/ rejection, implementation, verification, possible validation, and close of project. The beginning of one task can be made dependent on the completion of another which reduces cycle time. To simplify the process, one form can be used for multiple changes, depending on how many documents / items are affected by a change. For example, a change control management form for a component used in making 10 products can have 10 attachments, greatly streamlining the process.
MasterControl change control management software facilitates the operations of each department with the help of virtual folders called Organizers. These Organizers allow users to easily search and retrieve documents and ensure that documents are effectively managed between multiple departments without any confusion. Each change can be categorized as low, medium, or high which specifies the level of attention required in planning and implementing the change. Once a change is implemented, the next step is to ensure that employees are trained appropriately. With documentation constantly being updated, managers can rely on MasterControl to conduct extensive training sessions in order to educate employees about the updates made to the existing standard operating procedures. MasterControl change control management software also allows initiators to evaluate changes in terms of validation and regulatory requirements. This eventually helps the company achieve compliance with FDA, ISO, and similar regulatory guidelines.
MasterControl change control management software also provides users with powerful reporting and analytics tools. The software can generate several types of reports that facilitate the evaluation of change control management systems and processes as well as the overall strengths and weaknesses of the business. These reports can be grouped together by date and charted. Data can be readily summarized at multiple levels (i.e., by product, department, root cause, etc.).
If you'd like more information about change control management from MasterControl, please feel free to contact a MasterControl representative.