Why do we need computer system validation?

computer system validation

Implementing CSV is crucial for a pharmaceutical company or a medical device manufacturer. For producing consistent and high-quality products having computer system validations is crucial. In the U.S., having CSV as specified by the FDA is mandatory. The FDA regulates the pharma industry in the U.S. and has specific computer system validation guidelines. The FDA oversees companies’ compliance with the set norms. In the U.S., the FDA code of regulations seeks validation. All FDA-regulated industries need to be validated with 21 CFR 11.

What is CSV or Computer System Validation?

Computer System Validation (CSV) is a validation process conducted by regulated companies. CSV is performed to make sure that a computer-based system returns data or information following a set of predetermined requirements.

CSV processes are based on applicable regulations and guidance documents, industry best practices, and the intended use of the computerized system being validated. CSV aids establish a fixed order following which companies manufacture drugs or medical devices and distribute them.

Using CSV ensures the following:

  • The system is transparent
  • The system is solid and tamper-proof
  • The system can produce reliable data consistently.
  • The system stores data in a safe and secured way.

Using CSV, companies can improve overall system performance and handle sudden complications efficiently.

Why is CSV important for the medical industry?

The CSV is an integral part of highly regulated industries worldwide. CSV is required to maintain the data integrity and the safety and efficacy of the product. In pharmaceutical and medical device manufacturing industries that deal with public health and safety, CSV is necessary. In pharmaceuticals and medical device manufacturing, the final products need to be compliant before they are launched commercially in the market. CSV acts as a Quality Management System to ensure product compliance.

Computer System Validation is required for businesses that conduct any of the following activities:

  • Drafting, developing, running clinical trials
  • Processing, packaging, and labeling
  • Storing and circulating
  • Installing and maintaining medical devices/equipment

CSV can be utilized to ensure

  • Safety: The products are safe for patients.
  • Accuracy: Test results are accurate and reliable
  • Security: The system records if and when entries are altered

Furthermore, using CSV, an organization can ensure reliability consistency of the system output.

GAMP Guidelines for CSV

In the pharmaceutical industry, manufacturers follow GAMP guidelines. Automated systems perform according to GAMP guidelines to ensure they have the required quality. GAMP uses a quality check after each validation phase. GAMP guidelines are supported and recognized by many regulatory authorities throughout the world.

The GAMP steps include:

Planning: During this stage, the company manager fixes the deadlines and the budget required to implement CSV. This phase also breaks down all stages by time and budget.

Detailing user requirement specifications: Here, all the functions to be performed are noted. 

Design specifications. A team gets involved in deciding the look of a particular function and how it functions to accomplish all tasks defined during the previous stage.

Configuring a system build. In this phase, configured scripts are written for the software.

IQ tests. Testers run scripts to check if they have correctly installed the system into the user environment.

PQ tests — Performance qualification tests are done in the final stage. A CSV engineer tests worst-case scenarios to ensure that the system would continue working properly under poor conditions. The FDA requires the companies to follow the cGMP compliant procedures.

Reporting: All planned activities are scrutinized. A tester documents the result of validation and sets them up to demonstrate that the product is ready for release.

If you need professional help with CSV, you can hire a trusted team of experts for your computerized system validation projects.


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