Pharmaceutical Industry
Pharmaceutical companies face mounting pressure to ensure compliance with regulations governing computer systems associated with the product development and production. In the pharmaceutical industry you only get one chance – one mistake and the name of the company/product can be ruined forever. With the help of API PRO you can increase process reliability and with help of for example advanced planning facilities and analysis functions, circumstances affecting the production negatively can be eliminated.
We know the challenges of this industry and the demands to keep current with prevailing regulations. Through both education and learning from our pharmaceutical customers we have developed in-depth knowledge and awareness about demands and regulations of the pharmaceutical industry, such as GMP guidelines and the importance of system validation. Several validation projects have been performed of API PRO.
In the pharmaceutical industry there is a growing requirement for documentation of changes made to the production equipment. It is also necessary to keep track of maintenance procedures and whether any changes have been made to the procedures over time. These requirements are specified by FDA (U.S Food and Drug Administration) in the GMP guidelines.
To support these needs a change logging, also called audit trail, functionality is available in API PRO. The change logging functionality has been developed in close co-operation with our customers in the pharmaceutical industry and focuses on a complete logging of changes to data “close to the process”. Information regarding maintenance can at any time be recreated as it looked 20 or 2 years ago – no matter how much or how many times the records have been changed.
A calibration module is available which will support you in assuring the reliability of your equipment. With the calibration module, objects can be checked at regular intervals using a specified method and specified measurements to ensure that the readings meet specified standards.