UNC-CH_IFB_65-3000012502_Addendum#1_20251002_FINAL.pdf

UNIVERSITY OF NORTH CAROLINA at CHAPEL HILL

BID ADDENDUM

FAILURE TO RETURN THIS BID ADDENDUM IN ACCORDANCE WITH INSTRUCTIONS MAY SUBJECT YOUR

BID TO REJECTION ON THE AFFECTED ITEM(S)/SERVICES.

UNC Bid Number: 65-3000012502 Prospective Bidder: All Bidders Addendum Number: #1 Bid Opening Date/Time:

10/06/2025_03:00PM (EST)

Addendum Date: 10/02/2025

INSTRUCTIONS:

1. Return one properly executed copy of this addendum with your bid response by the Bid Opening

Date/Time listed above.

2. Please make the following change(s) in the bid referenced above due to questions submitted for clarification:

Q: Per the manufacturer, our VWR Data Loggers might work, but there are separate part numbers for - 80C ULTs vs -196C LN2 Dewars. Is there any more clarity on the “over 500” units, like how many of each type or a rough percentage? A. They probably don’t have enough just sitting on the shelf, so they were hoping for ballpark quantities to see whether they could meet the Nov 1 deadline.

A: Unfortunatly no, not at this time.

Q: We’ve got a ton of different manufacturing partners, and Elpro Services is probably most similar to the -80 Monitoring group you guys were using previously. Would we be allowed to submit multiple bids (ex: one with VWR brand stuff, another with Elpro stuff), or would we have to pick one and put our best foot forward with a single proposal?

A: Yes, but please do not submit a bid with a mix of both devices. Only send a bid with one device so compatability and uniformity would be the same. We do not intend to have various different systems monitoring freezers as this would mean more training to use the devices and more training to install devices.

Q: Am I missing any further details in the bid document besides “over 500 -80C and LN2 units across campus”? Is there any kind of map detailing how many and what types of units are in which buildings?

Maybe something left over from when -80 Monitoring was providing this service? A. If this information is not available prior to the bid submission deadline but will be later, will there be any opportunity to revise the (probably overestimated) “ballpark” bid based on these updates, or will we need to make our best guess / most competitive bid based on whatever available information?

A: No you are not missing anything. We can provide the building name and room number for most units. We have freezers ordered and shipped and die day to day so 500 +/- is the best we can do for a count. The +/- would be 10-20.

https://urldefense.com/v3/__https:/www.elpro.com/en/__;!!ORgV8lsu!pYn6HuxJdGETcQC_JNf-316C8PWrauTNxHcPRyw-QNlFCd3zkYVxe3UQ1R_RpDUKVGedHztaI58i6AxH6MjfqkFXRoZ3yWE$

Q: Can you confirm whether calibration must be ISO 17025 accredited or if NIST traceable calibration is also acceptable?

A: No. we have too many units and some will need to meet certain requirements while other may only need minimal requirments. Vendor should be able to perform and meet any industry standard requirements.

Q: Is 3-point calibration a mandatory requirement for all temperature sensors?

A: As long as it meets the requirement needs of each unit.

Q: Is a Digital Calibration Request system okay for this contract?

A: As long as it meets the requirement needs for each unit.

Q: Have you considered having the suppliers describe the recalibration process? e.g . Will it be onsite, do you need to ship something out for calibration and what do you do in the meantime.

To make sure that you don't end up with a system that takes a lot time to administrate and execute during calibration.

A: Yes, recalibration should be onsite or a process described for how we would ship out a monitor and how we would be monitoring that freezer while the monitor is shipped for calibration.

Q: Must the system support audible phone alarms specifically (e.g., automated call), or are SMS/email sufficient?

A: Yes

Q: Are you requiring multiple levels of alarm severity (Alarm, Alert, Notification) to be configured per device?

A: Yes

Q: Is the system expected to log a unique alarm ID for every triggered alarm and allow comments/acknowledgements?

A: Maybe not a unique alarm ID but it should be able to pin point which freezer monitor it is and where.

Yes comments or acknowledements should be able to be logged.

Q: Should the system support multiple contact points (e.g., more than one phone number and email per user)?

A: YES

Q: Please confirm whether Vendor or UNC is responsible for physical installation of sensors.

A: For the initial installation we would require the vendor to install. Once the sensors are all installed, UNC can assist vendor with replacing sensors and monitors as needed.

Q: Do you require DQ;IQ,OQ,PQ on the system after installation?

A: We may have some labs request this validation based on their requirements so please list that as a separate service item.

Q: Please confirm the required temperature operating range (e.g., -80°C, -196°C, -150°C, 2-8°C, etc.) and how many devices needs to operate in the different temp ranges.

A: We have numerous freezers and LN2s that operate at different ranges and cannot give an exact amount. We cannot give a specific amount yet, but its going to be around 500 in total.

Q: Is it a requirement for the system to allow the team to perform and log temperature excursion evaluations directly within the software?

A: It would be a nice feature.

Q: Must temperature values be displayed in Celsius only, or is Fahrenheit also needed?

A: Both if possible but Celsius would be our default.

Q: Should each user profile be able to manage and be associated with one or more specific sensors?

A: Yes

Q: Should centralized dashboards allow filtering by user, department, etc.?

A: Yes

Q: Must the system ensure seamless reporting continuity even if sensors are swapped mid-reporting cycle?

A: Yes

Q: Is full compliance with FDA 21 CFR Part 11 and GxP required, and will documentation be requested as part of the bid?

A: Yes and yes.

Q: Is support for REST API or similar integration mechanisms mandatory for connection with internal UNC GxP systems?

A: We are unsure as our IT department has not responded to our request.

Q: Must the interface include embedded support contact information, manuals, and user guides?

A: Yes

Q: Please confirm that you require vendors to have completed validation under GAMP5 or equivalent.

A: Yes

Q: Are vendors required to demonstrate future scalability both in sensor volume and compliance with future GMP/GDP requirements?

A: Not necessarily. If your scalability is only up to 500 units, then you would be at your maximum. Our research will likely continue to grow and require more freezers to be monitored so yes if you are near the maximum of your scalability.

Q: Section 4.6 Page 9. Would it be acceptable to include University of North Carolina research labs currently using our system as a reference in our proposal?

A: Yes.

Q: Scope of Work Page 20. Could you please clarify how many sensors are required to be NIST-certified?

Alternatively, would you prefer we list NIST-certified sensors as a separate line item for pricing purposes?

A: We do not have a specific number of sensors that would need to be NIST certified, but please list that as separate pricing.

Q: Scope of Work Page 20. For ongoing support, would you like us to quote options for 1-year, 3-year, and 5-year terms? Or is there a preferred duration we should focus on?

A: we would like quote options for 1 year term and then one for a 3 year term. The state of NC will not allow us to enter into contracts for more than 3 year terms.

Q: Scope of Work Page 20. Can you please confirm that your environment supports a gateway device connected via Ethernet, with wireless sensors transmitting small data packets (e.g., temperature readings every 5 minutes) to the gateway using 2.4GHz communication? In our architecture, only the sensors use 2.4GHz wireless to communicate locally with the gateway, which is hardwired via Ethernet to the network. This design ensures that all inbound and outbound data traffic to and from the cloud (AWS) is transported over Ethernet, not wireless, thereby minimizing RF exposure and interference. We want to ensure this configuration aligns with your requirements, particularly regarding the use of 2.4GHz spectrum for local sensor-to-gateway communication only, not for broader network connectivity.

A: This is acceptable for low volume 802.11 transmissions. Channels 1, 6 or 11 must be used. Please refer to the revised SOW language (on last page).

Q: IFB Section 4.0 Requirements – Scope of Work, Page 20. Could you please confirm the number of units that will require annual calibration certification?

A: we cannot give a specific amount yet, but its going to be around 500.

Q: IFB Section 4.0 Requirements – Scope of Work, Page 20. The IFB requires vendors to submit a firm fixed price for monitoring “over 500 freezers and LN₂ tanks” across UNC’s central campus. To provide accurate and comparable pricing, can UNC please provide: (1) the exact number of freezers and LN₂ tanks requiring monitoring; and (2) a layout or list of installation locations across campus where devices will be deployed?

A: We will have +/- 500 monitored units on campus and this fluctuates month to month typically on an upward trend. We can provide building names and room numbers for the majority of the units on campus, there are a very few locations that will require a UNC person to escort vendor to resticted locations.

Q: IFB Section 4.0 Requirements – Scope of Work, Page 20. Does the annual calibration certification require a one-point or two-point calibration?

A: minimum of one-point required

Q: In the Scope of Work, I see that you would like everything installed by November 1, 2025. Can everything be installed in the same time period (within1-2 weeks of each other)?

A: Yes.

Q: Would you consider a self-install option, where we would send you a self-install guide, as well as provide you with unlimited remote support when you are installing the system? This would cut down on the cost of having to send out an installer multiple time.

A: Yes but only for replacement when a unit is malfunctioning or needs to be replaced for any reason.

Vendor should install all monitoring devices upon initial award.

Q: Will UNC provide a specific Excel pricing template to correspond with Attachment D in the RFP, or should vendors supply their own detailed breakdown in Excel format with verifiable formulas?

A: no

Q: Given the urgency of services being in place before November 1, will UNC accept early installation/delivery ahead of the requested delivery date?

A: Yes

Q: Can UNC clarify the approximate number of freezers vs. LN2 tanks that will require monitoring?

A: we cannot give a specific amount yet, but its going to be around 500.

Q: For calibration, what percentage or number of devices should receive annual NIST or ISO 17025 certification?

A: We do not have a specific number of devices that will require that certification, however we may have some that will require it. Please list out a separate cost per unit for NIST and ISO 17025 certification. We would let the selected vendor know when we need this type of certification done.

Q: The IFB prohibits use of 2.4GHz, 5GHz, or 6GHz wireless. Is there a preferred alternative communication method (e.g., sub-GHz wireless, cellular, or wired), or is vendor discretion acceptable?

A: The preferred communication method is a technology which operates outside of the spectrum used by 802.11. Please note that it may not be feasible to use cellular technology in some locations due to poor cellular signal within the building. Please refer to the revised SOW language (on last page).

Q: For self-installation, what level of support and documentation does UNC require from the vendor?

A: Clear and concise documentation for installation and validation that its working correctly.

Q: Under “annual infrastructure costs,” should vendors itemize software licensing, hosting, and hardware support, or is a single annual fee acceptable?

A: yes please itemize those.

Q: Are deviation reports required in a specific format (e.g., PDF, CSV, or API export for integration with UNC systems)?

A: No

Q: For multiple contact notifications, must the solution support SMS and phone alerts in addition to email, or is email-only sufficient?

A: Yes it must include SMS/phone alerts.

Q: Does UNC require the monitoring software to integrate with existing UNC systems (such as Active Directory or Research IT platforms), or will it operate as a standalone system?

A: It will be a standalone system

Q: Will UNC require vendors to propose a defined on-site service response time (e.g., within 24–48 hours) during the warranty period?

A: If the device goes down yes we would need it to be repaired and/or replaced within 24 hours for continuity in monitoring.

Q: Should vendors include multi-year maintenance pricing options beyond the initial 12-month warranty period?

A: If the maintenance is not included in the ongoing annual monitoring cost yes. Please have that clearly broken out for each additional year up to three (3) years.

Q: Can UNC confirm how many total sensors are required, and whether each freezer/LN2 tank will require a dedicated sensor?

A: we cannot give a specific amount yet, but its going to be around 500.

Q: How many separate buildings or facilities on the central campus will be included in the monitoring system installation?

A: 3-6 buildings

Q: For freezers with multiple compartments or shelves, does UNC require a single sensor per unit, or multiple sensors per compartment?

A: Single sensor per unit

Q: Will UNC provide an inventory list of all units to be monitored, including type (e.g., ultra-low freezer, LN2 tank) and location, prior to installation?

A: We will provide information as we set up the installation waves.

Q: Does UNC expect vendors to propose additional spare sensors or backup equipment beyond the ~500 units, to allow for replacements or expansion?

A: We would like a per sensor price for installation and if they are not covered under warranty for replacement.

Q: Can UNC confirm how many total sensors are required, and whether each freezer/LN2 tank will require a dedicated sensor?

A: we cannot give a specific amount yet, but its going to be around 500.

Check ONE of the following options:

Bid has not been submitted e-Bid. Any changes resulting from this addendum are included in our bid.

Bid has already been submitted e-Bid. No changes resulted from this addendum.

Bid has already been submitted e-Bid. Changes resulting from this addendum are as follows.

Execute Addendum:

Bidder:_______________________________________________________________

Authorized Signature:________________________ Date:_____________________

Name and Title (Typed):_______________________________________________

Office of Vice Chancellor for Research South Building, 200 E Cameron Ave #312 Chapel Hill, NC 27514 Ph: (919) 962-1319

Scope of Work The University of North Carolina at Chapel Hill is seeking vendors to provide temperature monitoring down to -80 degrees Celsius for over five hundred freezers and LN2 tanks across our central campus in Chapel Hill.

Monitoring Services Requirements:

• Annual NIST or ISO 17025 calibration certification for a subset of temperature monitors in our freezers that must have clinical samples.

• Maintenance Costs: The ongoing maintenance of the freezer monitoring devices must be included in the cost.

o Installation and maintenance costs need to be clearly defined by device.

o If installation can be done by UNC then there need to be separate options for self-installation with defined installation instructions included.

o Annual infrastructure costs must be clearly defined.

What does it include?

Is it required?

• FROM: Equipment should not operate in the 2.4GHz, 5GHz, or 6GHz spectrum for wireless communication.

TO: Equipment should not operate in the 5GHz or 6GHz spectrum used by 802.11. If equipment operates in 2.4GHz it must use channels 1, 6 or 11. Equipment which operates outside of the spectrum used by 802.11 is preferred.

• Software Capabilities: A software system must be included with the alarm monitors that provide the following features:

a. Generation of deviation reports

b. Multiple contact notification options

c. Allow customizable monitoring parameters for each freezer or LN2 tank.

Timeline for delivery:

The existing alarm shop will close on November 1st. Services must be in place before this date to ensure continuity. We aim to expedite this process and finalize the contract details promptly so that the impacted units can begin transitioning to the new system without service disruption.

BID ADDENDUM