Developing and manufacturing a stable and safe medical device is difficult for even the most experienced manufacturers. How can you ensure you manufacture highly predictable medical devices that offer consistent performance with minimal variation? The answer is process validation.
Process validation is the framework around your medical device manufacturing process that ensures your device is installed and operates appropriately while providing continuous and stable performance.
The first significant phase of process validation is Installation Qualification (IQ).
What is Installation Qualification (IQ)?
Installation Qualification ensures the correct installation of your device in its operational space. Installation Qualification is done by facilities, production teams, engineers, and trained service personnel. The installation phase consists of checking equipment, services, instrumentation, cables, piping, and more against the engineering drawings, installation manuals, and instrument diagrams, as well as against the functional specifications from the development planning. Essentially, you are checking that the required floor or physical space is available, that operating conditions are correct, and that every conduit, gauge, hose, and other system elements are in their place and undamaged after installation. For software, you verify folder structures and system requirements, as well as a host of other factors specific to your software.
During installation qualification, you also check that calibration or adjustment schedules and maintenance schedules are established and recorded. Likewise, you should ensure that all the proper procedures surrounding the installation qualification are established and known by the relevant personnel.
What are the requirements for Installation Qualification?
Installation Qualification touches on many aspects related to installation and should always be described in a standard operating procedure (SOP), checklist, or, preferably, both. The installation requirements should be thoroughly described in the SOP. These requirements can come from:
- Design specifications
- System specifications
- Manufacturer recommendations
- Developers recommendations
The critical areas of installation qualification are described in 21 CFR 820.70. They are related to maintenance, inspection, adjustments, and automated processes.
- Maintenance schedule: Manufacturers must ensure an adequate maintenance schedule is set up to deal with the equipment's adjustment, cleaning, and other maintenance aspects. The maintenance schedule is set to ensure specifications are met. Records of the maintenance activities, including dates and individuals performing the maintenance activities, must be kept.
- Inspection: Manufacturers should conduct periodic inspections to ensure the maintenance schedule and activities are performed according to the established procedures. Manufacturers should always keep records of the Inspections, including the dates and individuals performing the inspections.
- Adjustment: Manufacturers should ensure visible postings on or near the equipment describing the limitations or tolerances of the device if the device is meant to be continually adjusted. The instructions should be visible and easy to find for any personnel performing adjustments.
- Automated processes: Any computer or digital system used as part of the production process must first be validated before the installation qualification is initiated to ensure its proper functioning.
Why should I do installation qualification?
Short answer: It's required by the FDA.
The longer answer is that installation qualification offers several benefits to medical device manufacturers:
- It reduces the risk that devices are not correctly installed. When there are issues with the installation, there's a higher risk of faulty measurements or treatments, as well as adverse events and potential harm to the patient. Ensuring proper installation every time helps improve patient quality of life, which is typically the goal of medical device manufacturers.
- Potential device issues can be overlooked. When devices are not installed properly, you risk missing device issues that can cause problems for the user and patients or diminish the device's performance. For example, if your device is inadequately installed, you risk damaged components, lack of software backups, software that doesn't work correctly, or voltage or amperage requirements outside the local power supply. None of these issues might be apparent at first use, but they can cause problems down the line.
Installation qualification example
When you have your device in the location you want to set it up, be it physical or digital, your installation qualification could go something like this:
- Locate the physical installation space and check it is adequate in terms of floor space and outlets or drains.
- Document any computer-controlled instrumentation.
- Gather all manuals and certifications, so you have them on hand.
- Unpack and cross-check instruments, ensuring you do so according to the adequate instructions.
- Check components and instruments for damage.
- Check the power supplies and make sure they are correct.
- Install any ancillary instruments.
- Document firmware versions, serial numbers, and any other relevant device-specific information.
- Check and verify the environmental and operating conditions.
- Check software installation and accessibility.
- Perform and record any calibrations or adjustments done, as well as the dates and tools used.
- Verify connections and communications with peripheral or ancillary units.
Software installation qualification consists of different concepts, but the process is relatively similar.