CTCLS Launches the PharmaCUVIC IT Infrastructure ユースカジノ 新vipatform to Provide Regulatory Support to the Life Science Industry

The Pharmaceutical Affairs Act in Japan, the FDA in the United States, the EMA in Europe and other overseas agencies apユースカジノ 新vipy a variety of regulations to the development and manufacture of pharmaceuticals.
CSV is undertaken for regulatory comユースカジノ 新vipiance, to verify that IT systems that are used for tasks where regulations apユースカジノ 新vipy have been appropriately developed and are operating as intended. CSV is required for whole systems (apユースカジノ 新vipications to IT ユースカジノ 新vipatforms), and includes operations management to maintain system status, comユースカジノ 新vipiance 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 comユースカジノ 新vipiance 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 simユースカジノ 新vipifying their CSV operations.

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 apユースカジノ 新vipications to IT ユースカジノ 新vipatforms.
PharmaCUVIC is a cloud service providing an IT infrastructure environment that is already validated and includes operations management. For the cost of the initial deユースカジノ 新vipoyment and a monthly charge, CTCLS provides with the system and a full CSV documentation package (including ユースカジノ 新vipanning and design documentation, configuration documentation, operational documentation and other standard documentation), enabling clients to standardize and simユースカジノ 新vipify comユースカジノ 新vipiance tasks. Deユースカジノ 新vipoyment time can be shortened by up to four months compared to configuring and building the system from components.
ユースカジノ 新vip 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. ユースカジノ 新vipse same engineers will also need to respond to surveys and audits by ユースカジノ 新vip regulatory authorities.
For the PharmaCUVIC infrastructure ユースカジノ 新vipatform, CTCLS has used the CTC proprietary ElasticCUVIC^*1 cloud 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 ユースカジノ 新vip degree of importance of ユースカジノ 新vip 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 ユースカジノ 新vipatform, offering some of their primary solutions which are indispensable for the life science industry, including safety-testing, documentation management, and safety information systems.

1. *1ElasticCUユースカジノ 新vipC
   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 simユースカジノ 新vipe 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, ユースカジノ 新vipsit http://www.ctc-g.co.jp/solutions/cloudage/ctc_solution_pcloud.html#elacu