Computer System Validation

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COMPUTER SYSTEMS

What is Computer System Validation - CSV?

The validation proves with documentation that computer systems used in industrial production adequately fulfill their automatic functions and contribute to ensure the traceability of produced batches and meets GMP regulations. Every computer system that has a direct or indirect relation to the production of the medicine, product for health or impact on traceability, must be validated, because it is a GxP system.

The first important activity of the Computer Systems Validation professional is to gather all the available documentation about the system which is object of the study.

Validation Lifecycle
METHODOLOGY

Validation based on risk approach

The study of the existing documentation to survey the risk scenarios is extremely important to know the particularities of the system to be validated and to meet cGMP guidelines. However, after some systems have been validated by the professional, some risk scenarios are invariably presented, such as the system behavior facing power outage, study of access profiles, access security, quality of electronic record produced by the system including audit trail, application of electronic signatures, etc.

It is important to emphasize that Functional Risk Assessment must be done by a multidisciplinary team due to the need of adopting mitigation measures for the risks which result in "medium" and "high" levels. The acceptance of these mitigation measures must be agreed among the team aiming to really be functional, whether they are adopting new work procedures or improvements in the system. The measures to be adopted become the validation strategy and they are the main points where GxP validation should focus.

Important Note

For the Functional Risk Assessment, the participation of the system supplier or developer is recommended. When this is not available, a professional can be hired with knowledge in this type of system that is being assessed.

VALUE PROPOSITION

Why do I need to validate?

In addition to contributing for data quality and data integrity, the GMP validation lifecycle is valuable because it allows:

  • Extracting all the needed available resources in the system to cover the specific process safely
  • Make the technical knowledge team more in-depth about the system, avoiding that the knowledge stays entirely on the hands of the supplier (opening the "black box")
  • Document technical discoveries, avoiding the loss of knowledge in an eventual exit of professionals of the company (risk to the business!)
  • Explore all possible automatic features in order to avoid manual steps, leading to repeatability and reproducibility for the process (target of validation!)
  • Direct the team to analyze necessary actions and documented procedures for contingency planning, data backup and application, and disaster recovery, reducing production downtime (risk to the business!)
  • Reliability of process information avoiding operational errors
PROCESS FRAMEWORK

Learn more about Validation Life Cycle

GAMP5® Validation Guide

GAMP5® is a Good Automated Manufacturing Practice guide, the 5th version of 1st edition was released in 2008. Recently, in 2022, they published the 2nd edition of the guide. Since then, it has revolutionized the Validating Computer Systems method.

The guide is a set of "inspiration" for Computer Validation professionals and has as its central axis the risk-based validation strategy ("A Risk-Based Approach to Compliant GxP Computerized Systems").

Note: although each company has its specificity, there are several standard processes within a type of system, for example purchasing processes within an ERP, which are common to different companies. Taking this opportunity, FIVE has developed a paperless e-validation methodology to optimize efforts and ensure compliance.

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