Overview of CSV | Computer System Validation

Overview of CSV

Computer System Validation

■ What is Computer System Validation (CSV)?

Computer system validation (CSV) is performed under the ER/ES regulations to ensure the system’s reliability. The target and level of the CSV must be evaluated within each company, with consideration of its validity and appropriateness. Guidelines, such as GAMP, published by each country or industry groups, are effective for this.

Revisions are planned in the near future for the following US, EU, and Japanese CSV-related documents:

FDA General Principles of Software Validation (2002), USA
GMP Annex 11 Computerized System (1996), EU
Adaptive Management Guidelines for Computerized Pharmaceuticals Manufacture (1992), Japan
■ Implementing CSV under GAMP

The GAMP (Good Automated Manufacturing Practice) guide, published by the International Society for Pharmaceutical Engineering (ISPE), describes guidelines to implement a computer system validation. (Latest version is GAMP5.) These are no more than guidelines, and compliance is not compulsory. However, many companies in the US and Europe have introduced the GAMP philosophy, making GAMP the world’s de facto CSV guidelines. The Japanese guidelines (see above) will also be revised according to GAMP.

GAMP recommends lifecycle management of the computer system. Lifecycle management is based on the concept of quality control throughout the lifecycle of the computer system, from concept to retirement. GAMP5 proposes work tasks between the project phase and retirement.

GAMP5 recommends validation work according to the risk. The overall workflow in the project phase is defined as planning, specification, manufacture, verification, and reporting. It advocates a "risk-based approach" where the details of the validation are determined according to the risk. Taking due consideration of patient safety, product quality, and data integrity, a simple validation is adequate if the risk is low whereas a comprehensive validation is required when the risk is high.

Moreover, GAMP5 includes guidelines for dividing the software (or hardware) comprising the computerized system into categories and performing validation according to the category. (The categories shown are examples only. The final categorization and validation must be evaluated in each company.)

The operation phase involves maintenance management to keep the computer system in its validated state. Consequently, procedures for each task must be prepared before starting operation.

The retirement phase clarifies switching to a new system (immediately switch to a new system or operate systems in parallel?), data migration, and storage and disposal of hardware, software, and documentation.

Shimadzu provides total support for all phases, including advice on actual procedures and supplying reference material. Consult your Shimadzu representative for details.

For Research Use Only. Not for use in diagnostic procedures.

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