Computerized systems validation – GMP/FDA/GAMP

Validating computerized systems in compliance with GAMP and FDA guidelines is essential in the pharmaceutical, biotechnology, and other regulated industries (e.g. food production, medical devices).

Validation is the process of generating documented evidence that provides a high degree of assurance that a specific process will consistently produce a product that meets its predefined specifications and quality attributes (FDA definition, 1987).

Computerized systems validation under Good Manufacturing Practice (GMP) aims to document that IT systems operate as intended and ensure product quality. It is critical in sectors such as the pharmaceutical industry, where precision and system reliability are essential for drug manufacturing.

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What is computerized systems validation?

It is a documented process that confirms a computerized system operates according to its intended use and complies with legal and quality requirements.

Objectives of GMP computerized systems validation

Ensuring product quality

Validation confirms that computerized systems contribute to the production of products that meet defined quality standards.

Regulatory and standards compliance

Validation ensures that systems comply with applicable legal regulations and industry standards, including Annex 11 to the EU GMP guidelines and GAMP 5 recommendations.

Safety and reliability

Validation helps identify and eliminate potential risks that could impact the safety and reliability of systems.

Operational continuity

Validation supports the maintenance of systems in a validated state, ensuring stable and reliable performance over time.

GAMP 5 – Good Automated Manufacturing Practice

This standard, developed by the International Society for Pharmaceutical Engineering (ISPE), provides a framework and best practices for the validation of computerized systems. The latest version is the GAMP 5 Guide: Second Edition (2022).

Key principles of GAMP 5

Risk-based approach

Emphasis is placed on areas that directly impact product quality and patient safety.

System classification

From category 1 (standard hardware) to category 5 (custom business applications), systems are classified based on complexity and risk.

V-model methodology

A structured model that outlines the relationship between system development stages (requirements → design → testing → implementation).

Documentation

Required documentation includes: URS (User Requirements Specification), FS (Functional Specification), and testing protocols such as IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).

US FDA 21 CFR Part 11

These are U.S. regulations that define the requirements for electronic records and signatures. Systems used to store data electronically must:

ensure data integrity
protect against unauthorized access
include audit trails
enforce the use of secure electronic signatures

Main stages of GMP validation

User Requirements Specification (URS)

Defines the expected functionality and performance of the system from the user’s perspective.

Risk analysis

Identifies and assesses potential risks that may impact product quality or patient safety.

Functional and design specifications (FS/DS)

The Functional Specification (FS) describes how the system is expected to operate to meet the requirements defined in the URS.

The Design Specification (DS) provides detailed information on how the system will be built based on specific components and products to fulfill the FS. It typically consists of:

– Hardware Design Specification (HDS) – outlining the selection of hardware

– Software Design Specification (SDS) – describing the software components

Design Qualification (DQ)

Verification that the FS and DS are fully aligned with the URS and that the proposed design meets all user expectations.

Validation plan

Defines the scope, objectives, and stages of the validation process.

IQ, OQ, PQ testing

Execution of validation tests to confirm that the system functions as intended:

– IQ (Installation Qualification)

– OQ (Operational Qualification)

– PQ (Performance Qualification)

Documentation

All validation activities must be thoroughly documented, including risk assessments, test protocols, results, and reports.

Maintaining a validated state (change control, revalidation)

Computerized systems must undergo regular reviews to ensure they remain in a validated state, compliant with GMP requirements, suitable for their intended use, and aligned with internal quality standards.

Do you need to qualify a computerized system?

As part of our services, we provide:

Development of Functional Specification (FS)
Development of Hardware Design Specification (HDS)
Development of Software Design Specification (SDS)
Preparation of Risk Assessment (RA)
Creation of IQ/OQ/PQ protocols
Execution and documentation of IQ/OQ/PQ tests
Preparation of IQ/OQ/PQ test reports

Computerized systems validation – GMP/FDA/GAMP

YEARS ON THE MARKET

Let’s talk about computerized systems validation

What is computerized systems validation?

Ensuring product quality

Regulatory and standards compliance

Safety and reliability

Operational continuity

Risk-based approach

System classification

V-model methodology

Documentation

Main stages of GMP validation

User Requirements Specification (URS)

Risk analysis

Functional and design specifications (FS/DS)

Design Qualification (DQ)

Validation plan

IQ, OQ, PQ testing

Documentation

Maintaining a validated state (change control, revalidation)

Do you need to qualify a computerized system?

Contact us