Complete validation of computerized systems: ERP, LIMS, MES, mobile applications, medical devices and AI systems under GxP regulations and 21 CFR Part 11.

What is computerized system validation?

Computerized System Validation (CSV/CSA) is the documented process that demonstrates a software system consistently and reliably does what it is intended to do within a regulated environment. It is not about generating documentation for its own sake: it is about providing objective evidence that supports confidence in the data the system generates, stores or transmits.

Since the EMA's Annex 11 and FDA's 21 CFR Part 11 were published, validation has evolved significantly. GAMP 5 (second edition, 2022) introduces the Computer Software Assurance (CSA) approach, which prioritizes critical thinking and proportionality of effort to the real risk of the system.

Which systems require validation?

Any system that affects product quality, data integrity or patient safety falls within the scope of GxP validation. This includes:

ERP and MES: SAP, Oracle, Microsoft Dynamics and similar platforms used in production and quality.
LIMS: Laboratory information management systems under GLP or GMP regulations.
Warehouse management systems (WMS/EWM): With impact on traceability and temperature control.
Equipment and device software: Firmware embedded in manufacturing or analytical equipment.
Cloud and SaaS applications: Third-party platforms with access to GxP data.
Electronic signature systems: Which must comply with Annex 11 or 21 CFR Part 11.

Our approach: risk-based and critical thinking

We apply the GAMP 5 CSA framework with an approach proportionate to risk. We do not generate unnecessary documentation. Validation effort must be justified based on the potential impact of the system on quality and safety.

The typical process for a GxP system includes:

Validation Plan (VP): Defines scope, strategy, responsibilities and acceptance criteria.
User Requirements Specification (URS): Captures the functional and regulatory requirements of the system.
Risk Assessment (RA): Evaluation of impact on quality and safety to prioritize controls.
DQ, IQ, OQ and PQ Qualifications: Design, installation, operational and performance qualification documentation.
Traceability matrix: Links each requirement to the tests that verify it.
Validation Report: Consolidation of evidence and formal declaration of compliance.

Equipment qualification

In addition to software systems, we validate equipment with electronic components and embedded software: autoclaves, lyophilizers, HVAC systems, incubators, laminar flow cabinets and analytical equipment. The process follows the ISPE Baseline Guide for Commissioning and Qualification (C&Q).

Maintaining validated state

Validation does not end with the final report. Systems evolve: updates, configuration changes, migrations and new integrations can affect the validated state. We implement change control procedures and periodic reviews to keep validation active throughout the system lifecycle.

Why OqoTech?

With over 15 years validating systems in pharmaceutical, biotechnology, medical device and clinical trial environments, our team has first-hand knowledge of current regulatory expectations from the FDA, EMA and national agencies. We have participated in validation projects in more than 8 countries and supported clients during real regulatory inspections.

System Validation