Qualification & Validation Services
Ellab’s qualification and validation services is available in USA, Germany, France and the Philippines. Our validation team is filled with engineers with years of experience validating equipment that our temperature mapping equipment was made for. Clients that utilize Ellab’s qualification services are those that want a team that is professional, independent, efficient, good documentation practices, and of course they are experts in the equipment you need qualified. Ellab has committed to providing world-class service which leverages our expertise to meet all of your validation needs. We offer a full range of qualification and validation services for your cGMP/cGLP facility.
Our goal is to build long-term relationship with customers to support them whether it be purchasing equipment, providing rentals, or performing validation services on-site. We separate ourselves from the competition through our relationships with clients, dedicated and hardworking staff, and expertise in the qualifications we perform for you. We are only successful through your success
Services offered in the US
Qualification Services Provided
- Protocol Generation
- Installation Qualification (IQ)
Utilized for providing documentation to verify that all key aspects of the design, procurement, and installation are reported.
- Operational Qualification (OQ)
Utilized for providing documentation verifying that the system performs as intended at all anticipated operating ranges.
- Performance Qualification (PQ)
Utilized for providing documentation verifying that the process does what it is intended to do, in the correct and anticipated manner.
- Continuous Qualification (CQ)/ Re-Qualification (RQ)
Utilized for providing documentation verifying that the process is still performing to the standards necessary. Companies vary on their determination as to how often to perform re-qualifications. It is common to see sterilizers requalified annually, and CTUs vary between being requalified annually to every five years and everything in-between.
When it is time to retire a piece of equipment often companies will do a final qualification to ensure that before the unit is shut down that even till the end that it was meeting specification.
When To Use Ellab For Your Qualification and Validation Services
Unexpected projects: There are so many resources at your facility. When you have a project that needs to be completed quickly and you want a company to come in that can write the protocol, provide our own equipment, and staff that can be independent that you can rely on as your expert for those projects.
Large projects: When you have a large volume of qualifications or re-qualifications that need to be completed. We can handle projects that are larger in scale on condensed timelines due to the skill of our staff, and the quantity of validation equipment we have available. We can use your validation equipment as well. Our team is not only familiar with Ellab’s equipment, but also other systems.
Specialized Expertise: Our team is highly trained. Often clients hire us to perform some of the more complicated qualifications such as autoclaves and Steam-in-Place. We understand the needs to get your autoclave to cGMP, cGLP and EU (EN-285) specifications.
Staffing: Sometimes our clients just need an extra set of hands full time at their facility. We can provide staff for short and longer term durations.
What is our final deliverable? A completed protocol with summary report!
A binder which typically includes the following:
Executed protocols or SOPs
Hard and soft copies of mapping data. We provide you with a USB with all the data and ValSuite files
Calibration certificates for all mapping equipment used
Sensor pre-calibration/verification and post-calibration/verification
Validation personnel training records
We will even keep a copy of your file for 5 years. This is in case you accidentally misplace your binder, or need support from Ellab answering questions during an audit we can open the same file you are reviewing and provide guidance.