Corrective And Preventive Actions (CAPA)

Corrective and preventive actions (CAPA) can result from various processes, e.g. self-inspections, complaints or deviations. With BM-Flow you keep control of all processes and their dependencies. For example, if you are planning corrective or preventive actions as part of a deviation process, you document approval by the QA committee, monitor processing of the actions and adherence to the specified deadlines.

Corrective actions that have not yet been fully processed can block completion of the deviation process. However, it is possible to define preventive actions that are monitored over a longer period and do not block completion of the deviation process and, therefore, release of the batch.

Different attributes can be assigned to the actions, including from drop-down lists generated dynamically from external systems, e.g. item lists or lists of batches currently being processed.

Evaluations can be created for all actions, e.g. in respect of the type or the affected SOPs, facilities or equipment, machines, plants. Appropriately trained users can define reports themselves at any time.


arivis BM-Windream

  BM-Windream is the 21 CFR Part 11 compliant data and document management system for the pharmaceutical industry. It is based on the market leading windream document management system from wi... » more

arivis BM-Flow

BM-Flow supplements your BM-Windream system with functions for document management (e.g. for SOPs, manufacturing instructions, test plans, validation documents etc.) and management of typical quali... » more

Managed Documents

Provides electronic management of all kinds of managed documents, e.g. SOPs, qualification documents, manufacturing i... » more

Training Management

The training module of BM-Flow supports you in keeping abreast of these issues... » more

Managed Processes

Enables the user to map both GxP specific processes (CAPA, deviations, complaints etc.) and general processes... » more