This is the starting point before making any purchase, commitment or decision. Your requirements should be fully documented. If you need a machine to output 100 units a day, this forms part of the specification. If you need a sterilisation technology that sterilises your product, you want your product to be sterile but not so that it becomes un-useable because of the process. Your URS should stipulate everything you want the item or process to be and to achieve. The document can be used to procure the right equipment or a process or service that you require. By stipulating your exact requirements, you then have a benchmark for testing and calibrating. The URS should contain as much detail as possible, in general it is difficult to over-specify in your URS. For example should the material be stainless steel, should the legs be height adjustable, what size text should the LCD panel show, how many hours use before servicing, will the equipment fit through your access doors, and so on and so on.
Generally related to process equipment, the initial part of a validation, the IQ, assesses whether the equipment has been delivered and installed correctly, in an appropriate environment. This would include an assessment against the URS in terms of equipment construction, layout dimensions as well as connection to the services and functional operation. The actual operation is covered with the Operational Qualification. IQ may also be required where equipment has been moved.
Keeping to the process equipment theme, following the IQ, the equipment is assessed against its ability to operate to defined (normally within the URS) parameters. This involves defining the tests necessary to demonstrate compliance to acceptance criteria, performing those tests and documenting the outcome. In broad terms, the OQ should demonstrate that the machine is capable of performing within its specification, reliably and repeatedly.
The final stage should demonstrate that the machine is capable of achieving your intended output, reliably and repeatedly. Often there is an overlap between OQ and PQ but they are separate concepts, PQ is very much tailored to your specific application whereas OQ is generalised machine capability. In essence IQ assures you installed the intended equipment correctly, PQ assures that the equipment works to its design specification while OQ confirms that all of the above achieves your intentions. If there were any critical errors or omissions in the URS, these may not be apparent until the PQ phase. PQ may also involve determination of operational parameters that will achieve conforming product. PQ may also be required where equipment has been moved.
Validation forms an important part of regulatory compliance of medical devices. Any output that cannot be verified by tests or measurement must be validated. For example, you can test that a machine delivers 3ml of fluid into a pack by measuring it but sterility needs to be validated to confirm products are sterile. In a manufacturing example, there may be a machine that places a seal on a pack. To find out if the seal works, you would have to break the seal and test the contents for contamination, which then renders it un-useable. Likewise to test sterility would render the item un-sterile and un-useable. By carrying out a validation, you can demonstrate that the seals work or the product is sterile etc.
Validation processes involve performing and documenting adequate testing, having documents and records available to demonstrate that the equipment, process or system has been made/built correctly and that the system/process/machine is fit for the purpose. By validating, you aim to demonstrate that it does what it is supposed to according to your specification, it works correctly and that it can achieve the output requirements reliably, uniformly and repeatedly. Thus with the sealing machine we aim to test that it can put seals on correctly, there is the documentation to show that it has been built/installed correctly and lastly, the seals are fit for the purpose. In regulatory compliance terms, you have to validate to prove the output is correct and as specified.
As part of any validation, there are certain aspects to it, namely the User Requirement Specification (URS), the Installation Qualification (IQ), the Operational Qualification (OQ) and the Performance Qualification (PQ). These are further explained to the left of this window.
We always strive to deliver exceptional customer service allowing you to spend your time on other issues. At High Edge Consulting we can apply the principles of validation to any of your validation projects and have specific skills and understanding in the following areas:
• Cleanroom Performance
• Cleanroom Environmental Monitoring
• Sterilisation by Ethylene Oxide
• Sterilisation by Irradiation (Gamma & Electron Beam)
• Sterilisation by Moist Heat (Steam)
• Bioburden Recovery Methods
• LAL inhibition/enhancement studies
• Ethylene Oxide Gas Residuals Decay
• Automated Manufacturing
• Packaging
• Software
• IVD Systems
• IVD Automation
• Process Change
• Decontamination of re-useable medical devices
We can project manage your validation activities, assist with the creation of you URS, IQ, OQ, PQ, plan the validation, liaise directly with any subcontractors, check interim results and ultimately provide a formal summary report. We can write your validation protocol, ensuring to cover your requirements in detail so that all parties are fully aware of their responsibilities. Or, where a sub-contractor normally produces their own standard protocol, we can review this with your needs in mind so that you get what you need from the exercise. We can keep things moving, keep you informed of progress during the validation itself. On completion of the validation we will review all the raw data for accuracy before pulling together the information to produce a formal summary validation report written in terms suitable for your own use.
