CS Installation Qualification (IQ)

Installation Qualification (IQ) of Computerized Systems (CS) corresponds to Installation Qualification (IQ) in traditional validation (equipment qualification) and follows the Design Review/Design Qualification (DR/DQ).

During the IQ phase for CS, the following activities are required:

Confirm that the installed hardware matches the specifications and design documentation, including installation accuracy and quality.
Confirm that the installed virtual hardware matches the specifications and design documentation, including installation accuracy.
Confirm that the installed software matches the specifications and design documentation, including the correct version and licenses.
Confirm the completeness and accuracy of the provided documentation.

During IQ in the context of computerized system validation, the inventory objects include the physical hardware, virtual hardware, and software of the CS. The set of acceptance criteria for IQ in computerized system validation differs from traditional IQ due to the specific nature of the components being evaluated.

Hardware IQ

In the course of hardware IQ, indivisible units of computer hardware are treated and evaluated as a single object. An indivisible unit is a hardware object that is not repaired but replaced as a whole during regular maintenance. If, during the lifecycle of the system, the unit is disassembled and its components replaced or repaired, it should not be considered indivisible.

The breakdown into indivisible units may depend on the model of cooperation with the supplier. For example, if a workstation’s system unit is assembled or repaired by the company’s internal services, the indivisible units would be key components such as the motherboard, processor, memory modules, power supply, and drives. In this case, each component is individually assessed during IQ. However, if the system unit is supplied and serviced by a vendor under contract (with a sealed case), the entire system unit is considered an indivisible unit and treated as such in IQ. In this case, there are higher risks associated with the supplier, necessitating a stricter approach to supplier qualification (audits).

The following standard attributes of hardware components are verified during hardware IQ:

Component presence
Component name
Manufacturer
Model/modification/version
Serial number
Date of manufacture
Technical specifications
Hygiene aspects of design
Environmental requirements (e.g., cooling)
Utility requirements (e.g., power supply, compressed air, etc.)
Installation/connection quality
Correct installation/connection location
Representative positioning (for sensors)
Labeling
Documentation

Virtual Hardware IQ

Virtual hardware (Virtual Machine) is a software execution environment that emulates physical hardware for software installed within that environment.

A Virtual Machine (VM) possesses the same functional and load-bearing technical characteristics as physical hardware but lacks physical attributes like design, utility requirements (power, cooling), installation quality, manufacturer/model data, serial numbers, and dates of manufacture for functional components, etc. Software may not "know" that it is running on a virtual machine since the VM fully emulates hardware.

There are two possible approaches to virtual hardware IQ:

Treat the VM as part of the software configuration that enables its emulation. In this case, the VM is considered a Category 4 software component according to GAMP5 and is validated alongside the software that emulates it.
Treat the VM as physical hardware (an indivisible unit). In this case:
- The VM configuration is treated as the technical specifications.
- IQ is performed by verifying the VM’s configuration through the virtualization software’s user interface.
- This approach enables seamless integration with software validation, as the VM has all necessary virtual technical specifications, and the software should function as if installed on a "physical machine".
- The supplier of the system in this case is the developer of the virtualization software.
- The supplier is subject to qualification procedures (audits) as part of the virtualization software validation process.

Software IQ

During the installation qualification (IQ) for software, indivisible software blocks are treated and evaluated as single objects. When dividing the system into indivisible software blocks, consider:

Software from different suppliers.
Different layers of software with different categories.
Software from one supplier that can be delivered separately.
Software declared by the supplier as separate indivisible blocks.

If, during the system lifecycle, parts of an indivisible software block are separated and replaced, then the division into indivisible blocks was incorrect. It should be also noted that installing software updates/upgrades will result in the loss of the validated status of the system.

The following standard attributes of software components/modules are verified during software IQ:

Installed component presence
Name
Manufacturer
Modification/version
Serial number
License number
Configuration
Hardware requirements
Location (folders)
Documentation

During software IQ, the system usually needs to be powered on, and the software launched (to verify installation, version, licensing, etc.), whereas hardware IQ and traditional equipment IQ can be performed without powering on the systems.

Since software development and testing are often carried out on hardware different from the hardware on which the final system will be installed at the client’s site, the order of validation activities may change.

In this case, IQ is first performed during validation activities on the developer’s hardware/test environment, and after software validation and release, IQ and a series of functional tests – operational qualification (OQ) – must be repeated on the final hardware where the system will be operated.

The specialists at Tarqvara Pharma Technologies have years of experience in conducting qualification, validation, and acceptance tests within the pharmaceutical industry, in full compliance with international, European, and national GMP/GxP regulations and standards.