css 75F40126Q133352 Addendum 1.pdf
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- Solicitation number
- 75F40126Q133352
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This is a Combined Synopsis/Solicitation Addendum for a federal contract opportunity (75F40126Q133352) issued by ATLHAFL.
The solicitation requires the purchase, installation, and training of a 900 MHz wireless temperature monitoring system to continuously monitor and log temperatures in laboratory refrigerators, freezers, incubators, water baths, and ovens. The system must be currently listed on the FDA OIM Master Approved Technology list and ITIM/MAT approved under IM814142 within ORA. The vendor must be A2LA accredited and fully meet SRL's ISO 17025 accreditation requirements for calibration services, with calibration certificate documentation displaying the accreditation logo. The monitoring system must support approximately 140–156 temperature monitoring points with user-definable tolerances and provide immediate notification to laboratory personnel of out-of-tolerance situations. The system must be compatible with the existing CTP/TPL's Viewpoint server and existing software already in the building, and must conform to standard security controls applied to field VM servers on the regulatory network. Vendors may propose either an on-premises server solution or a cloud-based solution (Microsoft Azure). System coverage is required across three areas: Area 1 First Level (24,612 sq ft), Area 1 Second Level (26,632 sq ft), and Area 3 Second Level (15,777 sq ft). WiFi and Ethernet connectivity are available in monitored areas. Bluetooth 6.0 technology is not acceptable; only 900 MHz wireless technology is permitted. Installation must be completed within one month of award. The vendor is responsible for repairs or replacements of equipment damaged during installation; end-user damage requires a work order or purchase request. Under initial warranty, supplier responsibility for defects includes swap-out of plug-and-play components. Responses are due April 15, 2026, at 1:00 PM CST. FAR Clause 52.217-6 (Option for Increased Quantity) has been added, allowing option exercises any time before contract expiration.
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Combined Synopsis/Solicitation 75F40126Q133352 Addendum 1
All previous solicitation elements remain the same with the exception of the addition of FAR Clause 52.217-6, Option for Increased Quantity (Mar 1989) - “. . .any time before the contract expiration . . .”
To provide additional clarity of requirements the following Scope, Security Requirements, Questions & Answers, and Floor Plans are being provided.
Scope ATLHAFL, requires the purchase of an environment monitoring system that is currently on the FDA OIM Master Approved Technology list and is ITIM / MAT approved under IM814142 within ORA, requiring 900 MHz wireless technology to continually monitor and log the temperature of laboratory refrigerators, freezers, incubators, water baths, and ovens.
Vendor shall be A2LA accredited company that fully meets SRL’s ISO 17025 accreditation requirements for vendor calibration services.
ATLHAFL, requires the purchase and installation and training of the wireless temperature monitoring system to comply with the accreditation for monitoring analytical critical control points, the measurement calibration parameters on all probes shall be ISO 17025 accredited.
Documentation of this accreditation is required, with the logo provided on each calibration certificate. Temperature is an analytical parameter that influences the outcome of many methods utilized in the regulatory laboratory. As such, it is critical that the laboratory accurately document the performance of numerous instruments in the laboratory regarding temperature stability and uniformity.
It is also essential that the monitoring system provides immediate notification to laboratory personnel of any out of tolerance situation (e.g. said tolerances must be user definable). As it removes the human variability associated with failing to document, incorrectly documenting and failure to report temperatures that exceed or fall below the required analytical parameter.
It additionally will provide the opportunity to reduce the time commitment regarding utilization of laboratory personnel and provide a more uniform collection of critical analytical temperature data throughout the laboratory.
Security Requirements:
The security on the server system will be the standard security controls applied to all of our field VM servers on the regulatory network - which is already in production. (And would be the same on any upgraded version)
Questions Received from Potential Providers Responses are in Blue…
• We need a floor plan with the covered areas delineated to verify coverage – Approximate Sq Ft/Area Floor Plans provided below…
• If someone breaks something, are you asking us to fly down and replace it at our cost – If something is broken by the vendor, they are responsible for its https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_217_6 repair/replacement, if broken by end-user the is responsible and a work-order or purchase request created.
• If a part had a defect, can swap out a plug and play component – under intimal warranty if a defect occurs it is the supplier’s responsibility to correct the defect.
• Will a server based on prem or a Wireless to secure (Microsoft Azure) customizable
Cloud solution would be preferred? – You may propose your solution; it will be evaluated. The building will already have CTP/TPL’s Viewpoint server and existing software.
• Also are they a part of any GPO? – There are very strict security and configuration settings used to manage users and computers in an Active Directory environment, streamlining administration and enforcing security compliance.
• Number of monitoring points? – As specified in solicitation Minimum
Technical Requirements - Approximately 140-156 inputs with varying temperature setting.
• Interested in any of Dickson's Services (mapping, installation, etc)? - You may propose your solution; it will be evaluated – see Minimum Technical Requirements
• What is being monitored (fridges, freezers, incubator, warehouse space, etc…)? - As specified in solicitation Minimum Technical Requirements.
• Is there WiFi and/or Ethernet in the area being monitored? – Yes
• What is the rough timeline? - Within 1-month of Award.
• Total number of locations? - As specified in solicitation Minimum Technical
Requirements.
• Would Bluetooth 6.0 technology be an acceptable substitution for 900MHz technology? – No Bluetooth is not allowed – See Minimum Technical Requirements.
• It states that the system must be compatible with existing monitoring system. Is this an absolute requirement? - Yes, as specified in solicitation Minimum Technical Requirements.
• In order to get a very accurate quote, it would be necessary to have a walk through of the buildings that the system will be in. Will a walk through be hosted at any time during the RFQ process? – No, building in currently under renovation see below Floor Plans.
Response Due Date is extended to April 15, 2026, at 1:00 PM CST
Floor Plans - Area 1 First Level: Approximate 24,612 FT2
Floor Plans - Area 1 SECOND Level: Approximate 26,632 FT2
Floor Plans - Area 3 SECOND Level: Approximate 15,777 FT2
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