Change Control Management

Ensuring smooth implementation of Change Control processes to assist the organization in management of records from submission through implementation, verification and control, according to its standards and procedures. Generica QMS Change Control Management module provides effective management of changes in processes, engineering, facilities, machinery, equipment, documents, IT hardware/software, and other areas. It assists in improving change process efficiency and helps ensuring compliance across the organization’s departments.

Together with the importance of manaigng changes in the most efficient and effective way, companies in the Life Science industry are required to perform certain actions, and have accurate documentation when applying a controlled change. Generica Change Control Management module facilitates this regulatory requirement by allowing each customer to easily design and configure its own desired process. Generica enables a level of flexibility that supports integraitng a different procedure per the specific change control type (e.g. manufacturing vs. IT).


One of the things make Generica QMS an intuitive and friendly systme for users is its seamless integration with standard tools such as Word, Excel and PDF. This allows users to remian in their familiar work environment when performing their daily activities, and not needing to leave their relevant document. The majority of the actual work can be easily performed from those common tools, while they are being leveraged by Generica to support Generica QMS functionality and processes. This increases user productivity, while helping to ensure regulatory compliance.