Life Sciences Computerized System Validation (CSV)

Validation means confirmation of qualification, and involves "verifying that the equipment, procedure, and process required for pharmaceutical manufacturing and quality control produce the expected results" and "documenting" this.
Computerized equipment and systems use software such as operating systems and application, and their suitability is confirmed through computerized system validation, also known as CSV, which stands for "Computerized System Validation."

GAMP (Good Automated Manufacturing Practice) is a method for validating computerized systems, issued by ISPE (International Society for Pharmaceutical Engineering and Technology), and is a global standard practice guideline. The current version of GAMP, GAMP5, was published in 2008, and guidance issued before that is called GAMP4 to distinguish it from the current version.
In Japan, on October 21, 2010, the Ministry of Health, Labour and Welfare issued a notice from the Director of the Surveillance and Guidance/Drug Control Division, Pharmaceuticals and Food Safety Bureau, entitled "Guidelines for the Proper Management of Computerized Systems for Pharmaceutical and Quasi-Drug Manufacturers and Distributors" (hereinafter referred to as the "Proper Management Guidelines"), which was based on GAMP5, and came into effect on April 1, 2012.
Depending on the regulatory requirements of our customers, we may need to perform computerized system validation in accordance with these guidance and guidelines. We perform computerized system validation in Japan in accordance with the Appropriate Management Guidelines, but we also perform validation that meets the regulatory requirements of our customers.

We use our extensive product lineup to propose computerized systems that are suited to customer requirements, and our experienced and proven specialist engineers carry out validation work, create deliverables, and support the creation of validation documents.
This is one of the items to be implemented in computerized system validation. calibration We have been doing business in this field for many years and have built up trust and a track record. Temperature and humidity are also important factors in the life science field, JCSS Calibration We are a certified business operator and boast a high level of reliability.

One of the key points in implementing computerized system validation is categorization by software, and the content of validation varies depending on the category.
The table shows the category classifications given in the Appropriate Management Guidelines and examples of typical validation responses. Category 3 "configuration software" is software configuration (functions, etc.) does not change depending on the settings for operation, and configuration of our products that fall under this category include the KR series graphic recorder, application software with security features for wireless loggers, the CISAS/V4 data collection and monitoring package system, and the CISAS/ER electronic record management package software. Category 4 "configured software" is software whose configuration (functions, etc.) changes depending on the settings, and includes software that can achieve complex functions by combining software modules.
In the Guidelines for Appropriate Management, there are validation items to be implemented from "development Plan" to "Document Management" as shown in the table, and generally, the items to be implemented by suppliers are Functional specifications (FS), Design specifications, Installation Qualification (IQ), and Operational Qualification (OQ). We will not only validate the items to be implemented by suppliers, but also provide technical support and document creation support after consultation regarding other items.

Category classification and general correspondence examples

◎: Required ○: Depends on the results of system assessment (basically required) △: Depends on the results of system assessment -: Optional