Pharmaceutical guides

Computer system validation

What CSV is, why regulators expect it and how to approach it sensibly for an ERP.

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What computer system validation means

Computer system validation (CSV) is the documented process of showing that a computerised system does what it is intended to do, consistently, in a GxP-regulated environment.

Regulators expect systems that affect product quality, patient safety or regulated records to be validated. In the UK and EU, Annex 11 of the GMP guidelines sets out expectations for computerised systems.

For an ERP, the scope usually covers the functions that drive GxP records, such as lot tracking, quality status, batch records and audit trail, rather than every screen in the system.

Typical validation steps

A common, risk-based sequence.

Validation plan

Scope, approach, roles and acceptance criteria.

User requirements

What the system must do for regulated processes.

Risk assessment

Focus testing on what matters most.

Configuration specification

How the system is set up to meet requirements.

Testing

Installation, operational and performance checks.

Ongoing control

Change control, periodic review and access management.

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FAQ

Frequently asked questions

Computer system validation: documented evidence that a computerised system works as intended for regulated processes.

Computer software assurance (CSA) is a newer, FDA-led approach that puts more emphasis on critical thinking and risk, and less on documentation volume.

Yes, where it supports GxP processes. The approach should cover supplier controls and how updates are managed.

The regulated company is responsible, although suppliers and partners provide documentation and support.

Pharmaceutical and life sciences ERP