Both the pharmaceutical and the food industry have high demands and regulations to follow to assure that the product manufactured is of high quality. A high level of quality and safety during all phases of the manufacturing is a necessity. API PRO provides you with the tools needed to secure this quality.
It is often a requirement to be able to document changes made to the production equipment. It is also necessary to keep track of maintenance procedures, how often they have been executed - and whether any changes have been made to procedures over time. These requirements are specified by the American Food and Drug Administration (FDA) and especially within the pharmaceutical industry validation according to FDA requirements is a crucial factor.
The API PRO Change Logging Module has been developed in close co-operation with API PRO customers who need to pass the validation of the American Food and Drug Administration (FDA). It provides a tool capable of a complete and reliable logging of changes to data "close to the process".
With the change logging module, all changes in the central tables of the API PRO system will be logged. This will make it possible to see (and document) the status of for example a machine at any time throughout its life time. This will give you full traceability for all machinery, all working procedures, etc.
Especially when handling perishables, such as milk, it is crucial that the manufacturing process is allowed to run without any disturbances. When the time factor at a breakdown severely damages the outcome, API PRO provides tools and functions needed to be able to achieve successful maintenance management.
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