Validation of computer systems is a process required in the pharmaceutical industry. On the one hand, it is a necessity, on the other hand, an action that brings many benefits when implementing the system. Here’s what validation should look like and why is it important?

What is validation?

Validation is all activities that document in a documented manner that a given item (e.g. system, tool, but it can be a process) meets the requirements and criteria relating to its use or application. In simple terms, validation will be a confirmation of effectiveness.

In the pharmaceutical industry, the validation of IT systems is a required process regulated by the Regulation of the Minister of Health of March 13, 2015. In this case, it confirms that the delivered program works as intended, is adapted to the needs of the company and has been delivered and implemented in accordance with applicable standards (e.g. GAMP 5), as well as with the company’s internal regulations.

Why is validation important?

Validation is a very important process that provides knowledge about the quality of the implemented IT system, as well as its adaptation to the needs of the company. In the case of the pharmaceutical industry, it is also a confirmation of compliance with Good Manufacturing Practices, legal regulations and safety standards, as well as the fact that the system works in an accurate and repeatable manner.

Validation of IT systems in the pharmaceutical industry – when to do it?

Validation in the pharmaceutical industry is a process that begins at the design or implementation stage of the system and continues throughout its life, i.e. the operational phase, until its withdrawal. It also happens, especially in industries that are not required to validate, that it is performed already during the use of the system or is carried out as a periodic inspection. However, it should be remembered that (if possible) the optimal period for validation is just before the implementation of the IT system for use. However, this does not close the entire process, as a validated system still requires control and management of change, incidents, access and users, but also technical support and data recovery.

Validation of IT systems in the pharmaceutical industry – GAMP 5

Validation of the IT system is a set of specific activities, therefore it requires detailed planning and implementation in specific stages. The validation project should take into account the time of its execution, i.e. whether we perform it at the stage of designing, implementing or using a given system. It is also important whether the software was purchased or internally designed and created by the company.

General principles and guidelines related to the validation of computerized systems are contained in GAMP 5 (Good Automated Manufacturing Practice) and Annex 11 of the GMP (Good Manufacturing Practice) guide. According to these documents, the validation of the computer system should be carried out in the following stages:

• Preparation of a written validation plan
• Specification – specifying and approving requirements and conducting a design review.
• Test plans (IQ, OQ, PQ)
• Tests (IQ, OQ, PQ)
• Results overview and reports.

Recently, you can also see a new approach to the validation process – CSA (Computer Software Assurance for Manufacturing, Operations and Quality Systems Software), which reduces the emphasis on validation documentation, focusing on system testing and critical thinking.

The CSA focuses on issues such as:

• impact of software on patient safety
• impact of software on product quality
• software impact on system integrity.

GAMP 5 validation – what documents?

The validation process carried out in accordance with GAMP 5 requires the preparation of the necessary documentation. To do this, prepare:

• validation procedure
• Validation plan
• Risk analysis
• Inventory of all relevant systems, based on the assessment of their criticality
• Qualifications of system suppliers
• User requirements specification
• Design specification
• functional specification
• Specification of installation requirements.

GAMP 5 – how is the validation process?

1. Create a validation master plan.

The validation master plan is a formal document that describes the approach to validation in a given enterprise, defines the time range of planned works, their type and organization, and also provides rules for control, change control, deviation management, requalification, revalidation.

2. Specifications

Walidacja wymaga udokumentowania:

• URS specification – user requirements, specifies and defines the system functions that will be used
• functional specification FS – developed by the creator of the system, describes how the system works and behaves
• DS design specification – confirms the correctness of the system development process
• IS Installation Requirement Specification – Specifies the system requirements for the installation environment.

3. Qualification

Qualification is the conduct of documented field tests of the system. It is intended to demonstrate that the system has been properly installed, is working properly, and is producing the expected results. At this stage, the following is carried out:

• Design Qualification (DQ) – confirms the compliance of the system with the intended purpose.
• Installation Qualification (IQ – Installation Qualification) – confirms that the system has been installed in accordance with the design and manufacturer’s recommendations.
• Operational Qualification (OQ) – states that the system functions as intended and all its parameters function correctly.
• Process Qualification (PQ – Performance Qualification) – states that the system works in an effective and repeatable way in relation to the approved process and product specifications

4. Final validation report.

The validation report is a summary of the entire process. It describes the activities carried out and the results of the tests carried out. Its result decides whether the system is approved for use.