Computer Systems Validation Service for pharmaceutical laboratories and health products

validacion sistemas informaticos

In today’s pharmaceutical and medical device manufacturing industry, automated processes play a crucial role. However, the potential consequences of a malfunction in these automated systems are significant. Such a failure could compromise the quality of the product being manufactured, potentially posing a serious health risk to individuals who use the affected medication or medical device.


Importance of regulatory compliance


Given the potential health risks posed by malfunctions in automated systems, the validation of computer systems in the pharmaceutical and medical device industry is strictly regulated by organizations like the FDA (Food and Drug Administration) in the US and the EMA (European Medicines Agency) in Europe.


Computer systems present in manufacturing processes


A prime example of a computer system requiring validation in the pharmaceutical industry is the Laboratory Information Management System (LIMS).

In the medical device sector, validation of Enterprise Resource Planning (ERP) systems is prevalent as they often encompass manufacturing processes that could jeopardize product quality if malfunctioning or misused.


Validation and revalidation of computer systems


As previously mentioned, manufacturing companies are mandated to validate their computer systems. The ultimate goal of these validations is to ensure the quality, traceability, and data integrity of the products being manufactured.

It is crucial to recognize that computer systems employed in the pharmaceutical and medical device industry must be maintained in a validated state on an ongoing basis. These systems are subject to frequent updates, either to address identified errors or to incorporate new functionalities that enhance their performance. Prior to implementing any update, a meticulous evaluation of the proposed changes is required to determine their impact on the system.

This evaluation is critical and must be followed by a rigorous revalidation process to confirm that the updated system continues to operate reliably and meets all established performance criteria, thus ensuring its functionality and compliance with current regulations.


Computer system validation in the pharmaceutical and medical device industry is a cornerstone in ensuring the safety, efficacy, and quality of healthcare products. This methodical process not only adheres to regulatory requirements but also underpins data integrity and instills confidence in automated systems that play crucial roles in production and quality control. Validation is an ongoing lifecycle journey, adapting to system updates and technological advancements. Effective validation significantly contributes to patient safety and operational efficiency, solidifying its position as an indispensable practice in the relentless pursuit of excellence within the healthcare industry.

At SQS, we are experts in conducting the tasks encompassed by computer system validation, from validation planning and risk analysis to the final validation report, tailoring our activities to comply with the latest applicable regulations.


Contact an expert

If you want to know more about the topic or have any other type of question, do not hesitate, contact us.

Scope Validation of Computerized System

The main activities that are usually carried out to demonstrate its proper functioning are the following:

    • Validation Planning
    • Risk analysis
    • Design and development
    • IQ Testing Protocol
    • OQ Testing Protocol
    • PQ Testing Protocol
    • Traceability Matrix
    • Validation Report

Related industrial sectors

ISO 9001

ISO/IEC 27001

ENS-nivel medio

ISO 20000


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