Three tips for the efficient HW-IQ of IT systems in cleanrooms

Hardware-IQ (Image rights: Systec & Solutions GmbH)

To meet GMP requirements in the pharmaceutical industry, all facilities, equipment, and systems must undergo qualification. This is part of the quality assurance measures that are included in GMP. IT systems used within a process, such as production in the pharmaceutical environment, are also affected.

Systec & Solutions GmbH can already look back on numerous projects where customers were supported in hardware qualification and beyond, and offers three tips on how to streamline projects.

What do URS, DQ, IQ, OQ, PQ actually mean?

Using a project for planning and implementing GMP IT systems as an example, the qualification proceeds in the following steps:

URS: For the installation of IT systems in the cleanroom, a URS (User Requirement Specification) is created at the beginning of the project. In this document, the customer defines the GMP-critical parameters, including those relevant to the IT systems if necessary.

DQ: Based on the URS, the DQ (Design Qualification) is carried out. This verifies whether the hardware offers obtained meet the requirements specified in the URS. After testing processes with risk analysis, a successful DQ leads to a purchase contract with the selected supplier.

HW-IQ: After the delivery and installation of the ordered IT hardware, the HW-IQ (Hardware Installation Qualification) is performed. This compares the delivered hardware with the ordered hardware. It checks whether all requirements defined in the URS and the specifications are also fulfilled.

Additionally, the functions of the hardware are tested and thoroughly documented within the HW-IQ. This includes, for example, connecting a scanner or verifying the correct operation of input hardware (keyboard, touchscreen, etc.).

OQ / PQ: Subsequently, the OQ (Operational Qualification) and PQ (Performance Qualification) verify the IT system with the software used on it, as well as in conjunction with the entire process controlled by the system.

Tip 1: Involve GMP requirements from the beginning

The level of requirements for a qualification process for IT systems in the cleanroom is often not apparent at the outset. Including GMP requirements for IT early in the creation of the URS significantly simplifies the entire qualification process. Only when GMP-critical parameters are known early can a selection of suitable IT systems for the cleanroom be made.

Tip 2: Consider only suppliers of GMP-compliant hardware

Before choosing a supplier, a risk analysis must be conducted as part of the hardware DQ. Proper pre-selection of suppliers capable of delivering GMP-compliant hardware saves time, as potential risks are minimized or even eliminated through the specific design and construction of the hardware. This makes it easier for the responsible pharmacist to assess the risks accordingly.

Tip 3: Seek support for hardware IQ

After installation and before operation, the hardware must undergo a hardware IQ for GMP qualification. At the start of the HW-IQ, a hardware design specification is developed. Based on the ordered and delivered systems, a test protocol template is created for each device type, based on a defined test specification.

All documents must be reviewed before and after the hardware IQ in a four-eyes principle. Depending on the project size, the entire process can be particularly extensive, as all functions—such as correct installation, configuration, and communication with peripherals—are tested and documented using the test protocols.

Especially in time-critical projects and with parallel processes, it can be beneficial to commission an experienced service provider to handle the hardware IQ. This provider then takes over the creation of the documents and reviews before and after the HW-IQ. The contractor only needs to conduct the review on their side. This reduces the extensive coordination and documentation effort.

How can Systec & Solutions assist?

We are happy to support you throughout your project from start to finish. In addition to our promise to provide only cleanroom-compliant IT systems that significantly simplify qualification, our quality management team can assist you during the creation of the URS and the execution of the hardware IQ if desired. For all our platforms, you receive comprehensive documentation for use in GMP environments, which facilitates your risk assessment. We also support you with any necessary re-qualifications or IQ maintenance within the hardware IQ, hardware upgrades, or hardware reinstallation.

If you have questions about our GMP IT systems, the associated URS, and/or hardware IQ, please contact us at talk@systec-solutions.com or by phone at +49 (0)721 6634400.

Learn more about this topic in our technical presentation “Hardware Installation Qualification (HW-IQ) for IT systems in the cleanroom” and visit us at booth B2.9 at the lounges, which will take place from February 5-7, 2019, in Karlsruhe.