【11.22 Live】Turnkey project and computerized verification

In recent years, with the rapid development of new technologies such as big data, informatization, and artificial intelligence, as well as the influence of policy norms, centralized procurement and price reduction, the pharmaceutical industry has actively transformed
towards digitalization.
At present, from R&D, production, circulation to marketing and other core links, major pharmaceutical companies are exploring digitalization in order to achieve the purpose of
reducing costs and increasing efficiency, improving quality and low-carbon green development.
However, the road to digitalization of pharmaceutical companies is not smooth, the pharmaceutical industry is closely related to human health and safety, pharmaceutical + digitalization will involve a lot of cross-professional content, need to achieve compliance and meet regulatory requirements, in order to allow digitalization to promote the transformation and upgrading
of the pharmaceutical industry.
Among them, computerized system verification is one of the challenges faced by pharmaceutical companies in the process of digital transformation, and only through the verification of computerized systems can the quality of the system be guaranteed throughout its life cycle and always in a state of risk
controllability.
Computerized System Validation (CSV) is the state
in which a computerized system achieves and maintains compliance with regulatory requirements and intended purposes by performing the necessary life cycle activities and implementing the necessary operational controls.
Article 6 of the GMP Annex Computerized System stipulates that computerized system validation includes the validation of applications and the validation of infrastructure, the scope and extent of which shall be based on scientific risk assessment
.
The risk assessment shall fully consider the scope and use of the computerized system, and its verification status
shall be maintained throughout the life cycle of the computerized system.
The industry pointed out that the computerized system verification requires comprehensive testing and confirmation of the user requirements, design specifications, installation, operation, performance correctness and applicability of the computerized system to confirm that the computerized system meets the design requirements, technical indicators and user requirements, and the difficulty of completing this cumbersome process is not small, but also time-consuming and energy-consuming
.
At present, how to carry out computerized system verification has become a topic
that pharmaceutical companies have to face in their digital transformation.
In order to help pharmaceutical companies build smart pharmaceuticals that go hand in hand with compliance and efficiency, the fourth phase of Schneider Electric's Life Science Industry [Expert Materials] series of online live classes "Turnkey Project and Computer Verification" will be launched
soon.
At 15:00 on November 22, 2022, Yu Antao, Senior Technical Manager of Schneider Electric Project Implementation Center, will be a guest in the live broadcast room of Pharma.
com, sharing wonderful content from several aspects such as design consultation, product compliance, engineering compliance, and GMP verification process
.
Scan the QR code above to register 【About Schneider Electric】 Schneider Electric's purpose is to empower all people to make greater use of energy and resources, and promote human progress and sustainable common development
.
Our mission is to be your digital partner for efficiency and sustainability
.
We drive digital transformation to serve the home, building, data center, infrastructure and industrial markets
.
We achieve integrated enterprise management through integrated process and energy management
technologies, connected products, controls, software and services from the terminal to the cloud, throughout the business lifecycle.
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Disclaimer: Under no circumstances does the information or opinions expressed herein constitute investment advice
to anyone.