FormPipe Change Control

Change Control is a critical process for quality management in Life Science. Organizations operating within a regulatory environment are expected to have a pre-defined process for managing changes in order to maintain high standards regarding product and process quality.

FormPipe Change Control is a predefined process in FormPipe Life Science to ensure that changes in a product or some other relevant change (in e.g. machinery, computer systems, etc.) are coordinated in a controlled manner. This reduces the risk that changes are implemented without prior formal process or that the requirement for this particular change was not followed.

FormPipe Change Control ensures that companies within the Life Science industry comply with the regulatory requirements (21 CFR part 11) as set by authorities (FDA, EMA, etc.). Automated processes ensure that right people are involved at the right time, from initiation and analysis, to validation and approval. This is to ensure the quality of change and decision-making.

FormPipe Change Control provides complete transparency in the initiation-, review-, approval-, and signing history. A change that is to be implemented may also be connected directly to other processes related to quality management, e.g. FormPipe SOP Management & Training. Additionally, a greater overview of both current and completed change control processes is achieved.