CTC Life Science Corporation (headquartered in Setagaya-ku, Tokyo; Ryouji Yokoyama, President and Representative Director; hereinafter “CTCLS”), a CTC Group company that provides systems to the life science industry with a focus on pharmaceutical companies, announced today “PharmaCUVIC”, an IaaS cloud service that includes operations management. PharmaCUVIC systems are validated (CSV/computerized system validation), a requirement for IT systems used to develop and manufacture pharmaceuticals and medical equipment. CTCLS plans to expand the business with a focus on pharmaceutical companies and is aiming for 20 implementations over the next three years.
What is CSV?
The Pharmaceutical Affairs Act in Japan, the FDA in the United States, the EMA in Europe and other overseas agencies apply a variety of regulations to the development and manufacture of pharmaceuticals.
CSV is undertaken for regulatory compliance, to verify that IT systems that are used for tasks where regulations apply have been appropriately developed and are operating as intended. CSV is required for whole systems (applications to IT platforms), and includes operations management to maintain system status, compliance matters when decommissioning the system, documentation of the sequence of tasks in the IT lifecycle, and approvals by responsible parties. CSV activities are subject to surveys and audits by regulatory authorities and is considered a vital tool for guaranteeing the quality of pharmaceuticals.
Since maintaining compliance via CSV entails a wide variety of tasks and requires knowledge of relevant regulations and IT, pharmaceutical and other regulated corporations are seeking to reduce the administrative burden by rationalizing, standardizing and simplifying their CSV operations.
CSV Support and PharmaCUVIC at CTCLS
CTCLS has more than twenty years experience providing CSV services, including CSV consultation and assisting with the creation of CSV documentation. Our full-time engineers, who have business knowledge of the life science industry and expertise in dealing with regulations, have provided a range of system CSV solutions - including everything from applications to IT platforms.
PharmaCUVIC is a cloud service providing an IT infrastructure environment that is already validated and includes operations management. For the cost of the initial deployment and a monthly charge, CTCLS provides with the system and a full CSV documentation package (including planning and design documentation, configuration documentation, operational documentation and other standard documentation), enabling clients to standardize and simplify compliance tasks. Deployment time can be shortened by up to four months compared to configuring and building the system from components.
The operations management is handled by full-time engineers with specialist training in CSV, who will carry out maintenance and management in line with CSV requirements. These same engineers will also need to respond to surveys and audits by the regulatory authorities.
For the PharmaCUVIC infrastructure platform, CTCLS has used the CTC proprietary ElasticCUVIC*1cloud service to facilitate flexible system usage in line with business content by selecting menus that are tailored for purpose, such as combinations of operations and IT infrastructure in line with the degree of importance of the system, or options for additional functions.
PharmaCUVIC is one of the key solutions aimed at expanding business for CTCLS in the life science industry. In the future, CTCLS will also provide SaaS services on the PharmaCUVIC platform, offering some of their primary solutions which are indispensable for the life science industry, including safety-testing, documentation management, and safety information systems.
- *1 ElasticCUVIC
A CTC proprietary cloud service that provides services ranging from IT infrastructure building to operation and maintenance as a service for a monthly fee. By standardizing the services, CTC has developed a system of simple menus. In addition to a main menu of services with four levels of options for IT infrastructure and operations management, additional options such as providing middleware licenses and testing environments, and Disaster Recovery (DR) are also available.
For a detailed introduction, visit http://www.ctc-g.co.jp/solutions/cloudage/
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