Even if good engineering standards provide for well-defined procedures and schemes for its management, the issue of change control and configuration management has always been deeply felt and debated when it comes to systems used in regulated sectors such as that of Life Sciences .
The systems (composed of hardware, software and infrastructure) used in the production of drugs and medical devices are subject to validation, and the reference standards and methodologies (the ones most used by suppliers and users) have now become the Gamp (Good Automated Manufacturing Practices ) now in its fifth version, with the title “GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems”.
The Gamp5 document, issued by the Gamp Forum under the aegis of ISPE (www.ispe.org) brings together all the rules and indications for designing, developing and maintaining a "validated" system: it develops the concept of "Risk-Based Approach" which accompanies the "System Life Cycle" where all the activities to be carried out before the development and implementation and during the life of the system are defined in order to be able to keep it in the state of "validation" from its design, development, use and maintenance up to its decommissioning.
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ServiTecno (www.servitecno.it) is a company specialized in the supply of software and systems for industrial applications. Active in Italy since 1980, ServiTecno is characterized by the quality and the high technological content of the hardware and software products offered and by the competence and support to its customers, from the pre-sales phase, to product training, up to the post-installation technical assistance.
Since 1986 ServiTecno has been the distributor for Italy of GE Digital products, leader for SCADA/HMI and Plant Data Intelligence applications on networked PCs, with over 400.000 applications worldwide and a few thousand created by Italian companies, on various hardware and software, for small systems or for medium and large distributed applications.
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ServiTecno also completes its offer, through an articulated network of qualified partners, with a range of products and services in the field of Industrial Data & Efficiency Analysis; Cyber Security and Control System Protection; Change Control and Change Management; IT management of machine, department or plant maintenance; systems and services for M2M applications, products and services for Industrial
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