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A. URS Template (Editable)

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Purpose: This is a vendor-agnostic, editable URS skeleton for temperature mapping & monitoring systems across pharma, food, logistics, and data centres. Usage: Treat everything in {curly braces} or [square brackets] as fields for you to fill or adapt.

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A.1 Document Control

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A.2 Purpose & Scope

A.2.1 Purpose Describe why this system is being implemented.

This URS defines the business, regulatory, and technical requirements for a temperature mapping and monitoring solution covering [environments] at [sites/countries]. The system supports product quality, patient safety, food safety, uptime of critical IT infrastructure, and compliance with applicable regulations and standards.

A.2.2 Scope

• Sites in scope:
  • [Site 1, Country]
  • [Site 2, Country]
• Environments in scope:
  • Warehouses & distribution hubs
  • Cold rooms & freezers
  • Stability chambers / incubators
  • Transport assets (reefers, trucks, passive shippers, containers)
  • Retail refrigerated cabinets
  • Data centres, server rooms, edge computing rooms

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A.3 Applicable Regulations, Standards & Policies

List what governs your requirements (no need to be exhaustive here; you’ll cross-link in Appendix E).

• [Company] Quality Management System
• [Company] Data Integrity Policy
• [Company] Calibration & Metrology Policy
• Applicable GxP/GDP/GMP/GSP guidelines
• Applicable food safety / HACCP regulations
• Applicable data centre / IT standards & security policies

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A.4 Functional Requirements

Use tables per area for clarity.

A.4.1 Measurement Performance

(M = Mandatory, S = “Should”/Strongly recommended)

A.4.2 Mapping & Monitoring

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A.5 Data Integrity & Security Requirements

A.5.1 User Management & Access Control

A.5.2 Audit Trails & E-Signatures

A.5.3 Time, Backup & Retention

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A.6 Calibration & Metrology Requirements

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A.7 Integration & IT Requirements

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A.8 Validation & Lifecycle Requirements

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A.9 Reporting & Usability Requirements

(You can append A.10 Non-Functional Requirements: performance, response time, browser support, etc., as needed.)

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B. Mapping Protocol Template

Purpose: Standard template for any mapping study (warehouse, cold room, reefer, data hall, etc.).

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B.1 Administrative Details

• Study Title: Temperature Mapping Study – [Environment / Site]
• Protocol ID / Version: [MAP-XXX / vX.X]
• Site: [Site Name, Country]
• Environment Type: [Warehouse / Cold Room / Freezer / Reefer / Data Hall]
• Prepared By: [Name, Function]
• Reviewed By: [Engineering / Operations / IT / DC Ops]
• Approved By: [QA / Quality Head]
• Planned Execution Window: [Dates / Season]

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B.2 Objectives

Define clearly what you want to prove.

• To verify that the temperature distribution in [environment] remains within [X–Y °C] under defined operating conditions.
• To identify hot and cold spots and confirm worst-case locations.
• To confirm suitability of proposed monitoring probe locations and alarm limits.

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B.3 Scope & Boundaries

• Included areas: [Racks 1–10, aisles A–F, chambers 1–3, rows of racks, entire data hall, etc.]
• Excluded areas (with rationale): [e.g. buffer rooms, corridors not used for storage, non-critical IT rooms].
• Interfaces with other systems: [BMS, DCIM, process areas].

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B.4 Environment Description

Provide a narrative + diagram (attach to protocol).

• Dimensions (L × W × H)
• Layout (racks, aisles, cabinets, rows)
• Access points (doors, docks, hatches)
• Cooling / HVAC system description (location of evaporators, CRACs, AHUs)
• Known risk factors (solar load, frequent door openings, previous excursions, hot racks, etc.).

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B.5 Test Conditions

• Load state: [Empty / Partially Loaded / Fully Loaded; % loading; type of load used].
• Door operations: [Frequency, duration, simulation pattern].
• Operating setpoints: [Target setpoint(s), tolerance bands].
• Season / ambient conditions: [If seasonal extremes are relevant, document planned season].

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B.6 Instrumentation Plan

• Logger / sensor type(s): [Model, accuracy, calibration status].
• Sampling interval: [e.g. every 5 minutes].
• Total number of loggers: [N].

Attach a table:

Attach a location map as an appendix (B.6.1).

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B.7 Study Procedure

Stepwise instructions, e.g.:

1. Verify all loggers are within calibration and configured with correct sampling interval.
2. Place loggers at defined locations per instrumentation plan.
3. Allow system to stabilise for [X hours] before recording data for evaluation.
4. Operate environment in normal/defined conditions:
   • Maintain setpoints at [X–Y °C].
   • Perform planned door operations and load/unload cycles.
5. Record any events that may impact results (power dips, door left open, equipment failures).
6. After [minimum duration, e.g. 24–72 hours], stop the study and retrieve loggers.
7. Download data into [approved software] and verify integrity.

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B.8 Data Analysis Plan

• Data validation steps (check completeness, time-stamps, calibration validity).
• Statistical analysis to be performed:
  • Min, max, average, standard deviation per point.
  • Time outside specification per point.
  • Time to recover after disturbances (door opening, power interruption).
• Hot/cold spot identification criteria.
• Comparison across sectors/racks/rows or racks/cabinets.

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B.9 Acceptance Criteria

Define clearly:

• Primary criteria:
  • At least [X]% of recorded values at each position must be within [target range ± tolerance].
• Secondary criteria:
  • No sustained excursions beyond [Z minutes/hours].
  • Recovery times after door opening/power disturbances within [N minutes].

Include fallback approach for borderline results (e.g. risk-based review, repeat study).

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B.10 Deviations & Changes

• All deviations from protocol to be recorded with:
  • Description, time, logger(s) affected, immediate action taken.
  • Assessment of impact on study validity.
• Proposed changes requiring QA approval (e.g. repositioning of loggers mid-study).

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B.11 Reporting

State that a final mapping report will be produced per template in Appendix G, including:

• Methodology summary
• Results and visualisations
• Conclusions and recommendations
• Approved probe and alarm positions

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C. Audit-Readiness Checklist

Purpose: Quick, practical checklist to confirm that your mapping & monitoring system is audit-ready.

Use it as a recurring internal review tool.

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C.1 Governance & Scope

• Scope of monitoring system clearly defined (sites, rooms, assets).
• URS approved by QA/Quality and linked to validation documentation.
• Supplier selection documented with rationale and scorecards.

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C.2 Mapping

• Approved mapping protocols exist for each environment type.
• Mapping studies executed as per protocol, with deviations documented and assessed.
• Final mapping reports available, signed, and easily retrievable.
• Reports clearly show hot/cold spots and justify monitoring probe positions.
• Re-mapping schedule defined and followed (time- and event-based).

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C.3 Monitoring System

• All in-scope environments have defined critical control points and sensors assigned.
• Monitoring system is validated (IQ/OQ/PQ completed and approved).
• Site plans with sensor IDs are up to date and accessible.
• Alarm limits and delays are documented and justified.
• Alarm notifications and escalations are tested periodically and records kept.

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C.4 Data Integrity

• Unique user accounts; no shared logins.
• Role-based access control implemented and reviewed regularly.
• Audit trails enabled for all relevant data and configuration changes.
• Procedures exist for audit trail review for critical activities.
• System time synchronisation mechanism documented and verified.

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C.5 Calibration & Maintenance

• Calibration policy in place, approved by QA.
• All sensors/loggers show in-calibration status; no overdue devices.
• Calibration certificates are traceable to each device, accessible for inspection.
• Out-of-tolerance “as-found” events are investigated with impact assessments documented.
• Preventive maintenance for key components (gateways, controllers, power supplies) defined and recorded.

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C.6 Deviations, CAPA & Change Control

• Deviations related to mapping, monitoring, alarms, or data integrity are logged and investigated.
• CAPAs are defined, implemented, and followed up.
• System changes (software upgrades, configuration changes) go through formal change control.
• Validation impact of changes assessed and documented.

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C.7 Backup, Restore & Data Retention

• Backup procedures documented and executed as per schedule.
• Periodic test restores performed and documented.
• Data retention periods defined and implemented.
• Clear procedure for data export in case of investigations, regulatory requests, or system migration.

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C.8 Third Parties (3PLs, External Warehouses, Data Centres)

• Contracts/SQAs define temperature control and monitoring expectations.
• Evidence of partner mapping & monitoring available and periodically reviewed.
• Your organisation can reconstruct end-to-end temperature history for outsourced steps.

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D. Vendor Evaluation Scorecard

Purpose: A refined, ready-to-use scoring matrix that aligns with Chapter 8’s pillars.

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D.1 Summary Sheet Structure

Create a sheet with:

| Pillar | Weight (%) | Vendor A (Score 1–5) | B | C | | --- | --- | --- | --- | --- | | 1. Regulatory & Data Integrity Fit | 20 | | | | | 2. Mapping Methodology & Study Design | 10 | | | | | 3. Hardware Performance & Calibration | 10 | | | | | 4. Software Capabilities & UI | 15 | | | | | 5. Integration & IT Friendliness | 10 | | | | | 6. Scalability (Multi-Site, Multi-User) | 8 | | | | | 7. Services & Support | 10 | | | | | 8. Decision Governance Alignment | 7 | | | | | 9. Total Cost of Ownership (3–5 Years) | 10 | | | | | Total Weighted Score (1–5) | 100 | | | |

Scoring: 1 = Unacceptable; 5 = Excellent. Weightings can be adjusted by your governance team.

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D.2 Sub-Criterion Sheet (Example for Pillar 1)

You can add a detail tab per pillar:

Pillar 1 – Regulatory & Data Integrity Fit (Weight 20%)

| Sub-Criterion | Weight within Pillar (%) | Vendor A (Score 1–5) | B | C | Notes | | --- | --- | --- | --- | --- | --- | | Audit Trails (granularity & immutability) | 40 | | | | | | User Management & Roles | 20 | | | | | | E-Signatures / Review Workflows | 15 | | | | | | Data Retention & Export | 15 | | | | | | Supplier Understanding of GxP / HACCP / GDP | 10 | | | | |

You can replicate similar tables for other pillars (mapping expertise, IT fit, etc.).

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E. CFR / GDP / WHO / HACCP Mapping Requirements Table

Purpose: A working table where you map key regulation/standard families to your internal expectations for mapping & monitoring. Note: This is a structure; you will populate exact clause numbers and excerpts internally.

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(You can add columns for “Exact Clause ID” and “Link to Document” when you compile your internal master.)

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F. Data Logger Calibration Frequency Table

Purpose: Template to set and review calibration intervals. Note: Intervals must always be risk-based and consistent with your metrology policy.

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• Intervals above are illustrative starting points; they must be set, justified, and periodically reviewed by your internal calibration policy owners.

You can expand with columns like:

• “Historical Stability (Yes/No)”
• “Last OOT Event Date”
• “Interval Change (Shortened/Extended)”

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G. Sample Mapping Report Outline

Purpose: Standard, audit-ready structure for any temperature mapping report.

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1. Title Page

   • Report Title (e.g., Temperature Mapping Report – [Environment / Site])
   • Report ID / Version
   • Site / Location
   • Prepared by, Reviewed by, Approved by
   • Dates of study execution

2. Document History

   • Revision table listing versions, changes, and approvals.

3. Executive Summary

   • Short narrative:
     • Objective
     • Key findings (pass/fail)
     • Identified hot/cold spots
     • Key recommendations

4. Background & Scope

   • Description of environment and purpose (e.g., storage of [product types]).
   • Scope boundaries: included/excluded areas.

5. Applicable Standards & Requirements

   • Internal and external guidelines that motivated the mapping.

6. Environment Description

   • Physical layout (dimensions, racks, aisles, cabinets, doors).
   • Cooling / HVAC / refrigeration configuration.
   • Operational patterns (door openings, loading, process flows).

7. Instrumentation & Equipment

   • Logger/sensor types and specifications.
   • Calibration status summary (table).
   • Asset list linking device IDs to calibration certificates.

8. Study Design & Methodology

   • Test conditions (load, doors, setpoints, season).
   • Sampling interval, study duration.
   • Logger placement rationale (with diagrams).
   • Any pre-conditioning / stabilisation period.

9. Execution Summary

   • Actual dates/time of start and end.
   • Deviations or unexpected events during the study.
   • Any changes to planned conditions (with justification).

10. Results

    10.1 Data Quality Checks

    • Completeness, time synchronisation, anomalous points.

    10.2 Statistical Results (Per Logger / Zone)

    • Tables of min, max, mean, standard deviation, time in range.

    10.3 Spatial Analysis

    • Identification of hot and cold spots.
    • Comparison between levels, aisles, racks, cabinets, etc.

    10.4 Event Response Analysis

    • Behaviour during door openings, power dips, defrost cycles, etc.
    • Recovery times and temperature overshoots.

    10.5 Visualisations

    • Trend graphs.
    • Heatmaps / contour plots (where useful).

11. Discussion

    • Interpretation of results versus acceptance criteria.
    • Consideration of worst-case conditions.
    • Assessment of variability and risk.

12. Conclusions & Recommendations

    • Overall conclusion (environment suitable / not suitable for intended use).
    • Recommended monitoring probe positions.
    • Recommended alarm limits (with rationale).
    • Recommended process / layout changes, if any.
    • Need and timing for repeat mapping (if applicable).

13. Approval & Sign-Off

    • Names, roles, dates for preparer, reviewer(s), and approver(s).

14. Appendices

    • A: Layout diagrams and sensor locations.
    • B: Full data tables or selected extracts.
    • C: Calibration certificates or summary.
    • D: Deviation log and CAPA summary.

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H. Glossary of Acronyms & Regulatory References

Purpose: Make the guide readable for busy stakeholders who don’t live in acronyms all day.

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H.1 General & Quality

• ALCOA+ – Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available.
• CAPA – Corrective and Preventive Action.
• cGMP – Current Good Manufacturing Practice.
• GDP – Good Distribution Practice (primarily for medicinal products).
• GMP – Good Manufacturing Practice.
• GSP – Good Storage Practice.
• GxP – Collective term for good practice quality guidelines (GMP, GDP, GCP, etc.).
• QMS – Quality Management System.
• SOP – Standard Operating Procedure.
• URS – User Requirement Specification.

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H.2 Validation & Systems

• DQ – Design Qualification.
• IQ – Installation Qualification.
• OQ – Operational Qualification.
• PQ – Performance Qualification.
• CSV – Computer System Validation.
• CSA – Computer Software Assurance (risk-based approach to validating software).

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H.3 Measurement & Metrology

• RTD – Resistance Temperature Detector.
• Thermistor – Temperature-sensitive resistor used as a sensor.
• Thermocouple – Temperature sensor based on junction of two dissimilar metals.
• ISO/IEC 17025 – International standard for competence of testing and calibration laboratories.

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H.4 Food & Cold Chain

• FSMA – Food Safety Modernization Act (US).
• HACCP – Hazard Analysis and Critical Control Points.
• CCP – Critical Control Point (in HACCP).
• 3PL – Third-Party Logistics Provider.

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H.5 Pharma, Biotech & Health

• API – Active Pharmaceutical Ingredient.
• ICH – International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
• MHRA – Medicines and Healthcare products Regulatory Agency (UK).
• EMA – European Medicines Agency.
• WHO TRS – World Health Organization Technical Report Series.

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H.6 Data Centres & IT / OT

• ASHRAE – American Society of Heating, Refrigerating and Air-Conditioning Engineers.
• DCIM – Data Centre Infrastructure Management.
• BMS – Building Management System.
• OT – Operational Technology (industrial control systems, etc.).
• IT – Information Technology (enterprise computing).
• LPWAN – Low Power Wide Area Network.

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