Pharma and computer system validation

Why computer system validation (CSV) is important for the life sciences industry



For starters, CSV prevents software malfunction, but more importantly, it’s the law!

As the pharmaceutical and life sciences industries continue to modernize and implement more technology, there is an increasing need to be sure these technologies are safe and accurate for patients and end users.

CSV is a documented process for assuring that a computer system does what it is designed to do.

Both the European Medicines Agency (EMA) and the Food & Drug Administration (FDA) have produced guidelines for CSV practices.

There are two important reasons for performing CSV with life science technologies and software:

CSV can prevent software problems before reaching the usage environment. In particular in the clinical trial field, malfunctioning computer systems can cause serious adverse consequences to the patient. This could, in turn, lead to lawsuits, fines or eventual shutdown. 

Not performing certain computer system validations in accordance with best practices could be against the law. Both the EMA and FDA have rules and regulations in effect for Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and Good Clinical Practices (GCP). 

The FDA is aiming to strengthen its CSV standards by aligning them with international standards like ISO 9000:2000.

Good Automated Manufacturing Processes (GAMP) focuses on applying Good Practice Quality Guidelines (GxP) to the IT environment.

FDA regulations depend on the type of software being validated—off-the-shelf, configurable or customizable software—as well as ‘retrospective’ validation for older systems that have never been validated and business and compliance risks.

The EMA revised its CSV guidelines; topics include requirements for spreadsheets, security of databases, risk management, retrospective validation, storage time of electronic data and documents, and validation for small devices.

The EMA’s website offers the latest CSV regulations and validation. 

21 CFR Part 11 compliance is required for electronic records and electronic signatures.

CSV becomes important as the FDA requires all computerized systems with GxP electronic records to be validated.

The life sciences industry is proactive in validating systems in compliance with 21 CFR Part 11, which means the ability to generate accurate and protected records and time-stamped audit trails. 

Mary Wieder is with Italy-based pharma consultancy Arithmos.

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