Attachment 3-STMD Questionnaire Spreadsheet 3-12-2026.xlsx

Tab 1_Company Information Attachment 3 Questionnaire Spreadsheet Tab 1 - Company Information

Tab 2_RFI Questions 1-18 Attachment 3 Questionnaire Spreadsheet Tab 2 - RFI Questions 1-18

* A response is required for every question, or N/A if it does not apply to your company.

Describe several physical locations where the equipment can be installed and operated. Describe the equipment's primary and secondary power sources. Describe the equipment's operation during secondary/backup power supply for an extended period (i.e., 30 days). Describe the capability of your system regarding memory/data retention. Provide a rough unit price estimate for this equipment. Describe any volume or other discounts available for this equipment. Describe the equipment's wireless connectivity, communication and FCC compliance. Describe the equipment's remote access capability. Describe your equipment's adherence to applicable FCC regulations. Include licensing, approval, and manufacturing in accordance with all Federal, State, and local regulations, laws, and statutes. Have you been awarded a US Govt contract for equipment in the past 3-5 years that monitors pharmaceutical products? Is so, provide the contract number and agency/organization supported. Describe how your system has been used in an operational environment or used by customers. Describe how your system/software been utilized in a cGMP environment in pharmaceutical/medical storage. Describe how your equipment meets current Good Manufacturing Practice regulations (cGMP's) standards for providing temperature and security requirements of pharmaceutical equipment as outlined in 21 CFR Parts 11, 210, 211. Describe which cGMP-compliant document control program your company uses (i.e., Quality Manual, Standard Operating Procedure, Validation Documents, Change Control, Deviation, CAPA, etc.). Describe if your system automatically reports out-of-specification results, data loss, connectivity issues, interruption in service/power outage, Mean Kinetic Temperature (MKT), etc.. Describe how your system reports multiple alarm conditions (i.e., container opening alarm, temperature excursions, loss of power/connectivity). Describe how your report captures actual data and graphical representation. Describe the customization ability of reports for the customer (i.e., reporting high and low of the month/year, container/site numbers, days out of spec., MKT values, etc.). Describe the accuracy of your probes and the calibration tolerance/standards in terms of compliance with NIST. Describe how system maintenance and upgrades are handled and how oftern system upgrades are performed. Describe your average installation and validation time of units per site with units in various geographical locations. Describe your simultaneous performance of validations of units at multiple sites. Describe if your system is cloud based and if if it isFedRamp approved and authorized. Describe the data at rest and data in transit encryption with a FIPS compliant method. What is the method? Describe your system diagram to include backup systems and security posture. Provide documentation as a pictorial reference to description. Confirm whether your company would be willing and able to provide a virtual demonstration of a unit and software for evaluation assessment, at the company’s expense.

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Tab 3_Scenario Based Questions Attachment 3 Questionnaire Spreadsheet Tab 3 - Scenario Based Questions SCENARIO 1 – CHEMPACK Site Visit Schedule Adjustment

During routine quarterly maintenance planning, the Contracting Officer’s Representative (COR) must adjust the scheduled site visit dates for several CHEMPACK cache locations due to temporary facility access restrictions. The updated schedule must be communicated to all affected sites to ensure facility access, coordination with local personnel, and continuity of maintenance activities.

QUESTIONS:

1. Describe how your company would ensure that all affected CHEMPACK cache sites are promptly notified of schedule changes.

2. What communication methods or tools would you use to distribute schedule updates across multiple sites and jurisdictions?

During emergency response operations, a CHEMPACK container is temporarily relocated within a jurisdiction to support response activities. The Government must maintain awareness of the container’s location and ensure monitoring continues during and after the move.

QUESTIONS:

1. Describe how your monitoring system or operational processes would detect and record a CHEMPACK container relocation.

2. How would your system notify the Government of the relocation event?

A CHEMPACK unit experiences an unexpected door opening event outside normal operating hours. Because these units store critical medical countermeasures, the Government and designated local contacts must be alerted so the situation can be assessed.

QUESTIONS:

1. Describe how your monitoring solution detects and communicates door opening events to the Government and designated local contacts.

2. What alerting methods does your system use to ensure notifications are transmitted reliably?

3. What redundancy or fail-safe measures help prevent missed or delayed alerts? SCENARIO 4 – Statewide Monitoring System Deployment

The Government plans to deploy environmental monitoring units across multiple CHEMPACK storage sites within a single state. Installations must be coordinated with local site contacts and completed efficiently while minimizing disruption to site operations.

QUESTIONS:

1. Describe your company’s approach to planning and executing monitoring system installations across multiple CHEMPACK sites within a state.

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