Installations are generally done in person by a qualified Field Application Scientist. However, there are times when an in-person install is not possible due to location or safety restraints. In these instances, it is possible to guide the customer through the installation process remotely.
How To Run a Remote Install for an NC-200
- Find a space where you will be able to have an NC-200 in view of a camera
- The instrument, laptop stand, and cables should all be unassembled
- Be sure to have the flash for the demo unit and make sure to uninstall the software from the PC. This way you can go through installation of it with customer later.
- Prior to connecting through a web-based video meeting with customer (i.e Zoom), be sure to have your demo unit’s PC connected to the meeting as well so you can share the screen.
- For remote installs, we as the qualified scientist will fill out all paperwork for customer and send them a scan to sign as verifier. So, make sure to have copies of all paperwork available.
- Verify with the customer that whether a Via-1 or Via-2 PQ kit will be used, and ensure customer has the appropriate cassettes
Connecting with Customer and Beginning Installation Qualification
- Send customer a link to the video call.
- At time of the meeting ask them if they can also connect the PC for their instrument to the meeting as it will be simpler if they can share its screen during certain steps of the install.
- **If they are unable to do so, then they will have to hold their computer close to the instrument computer at all steps where I have denoted that the customer share their screen, so that you can view the necessary values on the instruments computer**
- Once everyone is logged in to the video conference you can begin the install.
- To begin, have them check to make sure they have all the necessary kits (IQOQ and PQ), all components, and some appropriate Via cassettes for the PQ kit to be run.
- Have them then check the serial number on the flash drive matches the S/N on instrument. Also have them check for marks or scratches, the CE and WEEE symbol, and for the 5 rubber feet.
- You should be showing them these items on your end as well, so they know what to look for.
- Fill out the Delivery Control and Physical Inspection sections in the IQ paperwork.
- Have the customer check the power supply for the NC-200. It should have ranges between 100-240V and 50-60Hz.
- Have them connect the Power Supply to the NC-200 and verify that the light turns orange (complete the verification of mains power supply section in IQ Checklist).
- Share your instruments screen
- Insert demo unit flash and have customer insert their instruments flash into their PC
- Guide them through software installation and reboot while sharing your screen
- Once completed and instrument is successfully connected, fill out Software installation section on IQ checklist
- Once this is done, have the customer share their instruments PC screen.
- Guide them to Help>About
- Fill in Instrument Specifications section on IQ checklist by reading numbers from customers shared screen
- Guide customer to Tools>Options and have them select the options they would like (highly suggest they select Save and All Users for PDF creation)
- If this will be using 21CFR, be sure they set up all User groups and then enable the 21CFR prior to proceeding to the IQ protocol. Have someone from each Group attempt to login to the Tools>Options to ensure restrictions are in place.
- Guide customer to select IQ Test and have them put IQ Test as sample ID.
- Make sure the customers initials/name is in Operator field
- Demonstrate loading Test cassette and have customer hit Run. Guide them through inserting the cassettes as prompted by software
- Once it is successful, complete paperwork and sign/date
- Fill in Instrument Specification numbers by transcribing from IQ checklist
- Have customer hold the IQOQ kit up to camera. Copy down the Lot and Expiration
- Repeat for the OQ Beads Type A and Via-1 cassettes
- Make sure the instrument is powered on and fill in System Check section
- Guide customer to select OQ Test and put OQ Test as sample ID
- Instruct customer to shake the OQ Beads Type A vigorously for 5-10 seconds.
- Demonstrate loading a Via-1 cassette and then have customer do the same.
- Have them press Run and guide them through the OQ Test
- Once successful, complete checklist and sign/date
- Have customer share their screen
- Fill in Instrument Specification numbers by transcribing from IQ Checklist
- Have customer show you the Lot and Expiration Date for the NC-200 PQ kit and Via cassettes (be sure that the kit and cassettes match the type of cassettes, Via-1 or Via-2). They should have 2 packs of cassettes both with the same Lot and Expiration date
- Fill in all ranges and CVs from the COA for the kit (works best if you look up COA for the PQ kit Lot the customer has and print it from website)
- Guide customer to Zero Count assay
- Have them type Zero Count for the Sample ID
- Have them verify there is no cassette inserted in the instrument and then have them hit RUN
- Once it passes, fill in the Zero Count Protocol section
- Have customer take out the 3 vials of PQ beads
- Have them verify that all 3 have equal amounts of solution and that the volumes do not indicate either leakage or previous use
- Have customer place Beads 2 and 3 back in container and out of light.
- Guide customer to select Viability and Cell Count Assay (either Via-1 or Via-2 depending on which PQ kit and cassettes they will be qualifying)
- Have them type Beads 1 for the Sample ID
- Demonstrate the correct way to invert the vial of Beads 1. Full, slow inversions for 30 seconds, followed by vigorous shaking for 5 seconds
- Demonstrate loading the cassette and inserting it in the instrument. Have customer do and then hit RUN
- Record total count and % viability on checklist
- Repeat process 4 more times, being sure to have customer invert Beads 1 vial 5 times before loading the next cassette.
- Repeat all for Beads 2 and 3. Be sure to instruct them to change the sample ID to either Beads 2 or Beads 3.
- Create Excel sheet and enter all counts for Beads 1-3 and calculate AVG, STDEV, and %CV. Insert values for AVG and %CV on checklist.
- Verify that AVG is within acceptable range and %CV is less than acceptable value.
- Complete paperwork, sign, and date
Completing all Paperwork
- Have customer attach the PDF’s for the IQ, OQ, and Zero Count to an email and send to you
- Print these and the Excel sheet, sign and date as performed by.
- Verify that you have signed and dated as performed by on all checklists, PDFs, and the Excel sheet and then scan and email to customer. Have them Print and sign (or digital signature if that is their preference) and scan a copy back to you for your records.