Calibration Documents: Temperature/RH Data Logger (CAL-0056)

Asset ID	CAL-0056
Equipment	Temperature/RH Data Logger
Equipment Type	TempRH Data Logger
Department	Validation
Area/Location	Stability/Storage
Process Use	Mapping
Parameter	Temperature/RH
Units	°C/%RH
Range Min	0
Range Max	60
Acceptance Criteria	±0.5°C/±3%RH
Calibration Frequency (days)	365
Calibration Type	External
Traceability	ISO17025

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Calibration SOP

1. Purpose

The calibration of the Temperature/RH Data Logger is performed to ensure accurate measurement of temperature and relative humidity within the stability/storage area. This calibration controls risks related to data integrity, patient safety, and batch quality by ensuring that the equipment operates within specified limits, thereby maintaining compliance with regulatory standards.

2. Scope

• Asset ID: CAL-0056
• Equipment Name/Type: Temperature/RH Data Logger
• Department/Area: Validation / Stability/Storage
• Process Use: Mapping
• Parameter: Temperature/RH
• Range: 0 to 60
• Units: °C/%RH
• Calibration Frequency: 365 days

3. Definitions

• Calibration: The process of comparing a measurement instrument to a standard of known accuracy.
• Verification: The process of confirming that a measurement instrument meets specified requirements.
• Adjustment: The process of modifying a measurement instrument to bring it into alignment with a standard.
• As Found: The condition of the equipment prior to any adjustments made during calibration.
• As Left: The condition of the equipment after calibration adjustments have been made.
• OOT (Out of Tolerance): A condition where the measurement falls outside the specified acceptance criteria.
• Drift: The gradual change in the output of a measurement instrument over time.
• Traceability: The ability to verify the history, location, or application of an item by means of documented recorded identification.
• Measurement Uncertainty: A parameter that characterizes the dispersion of the values attributed to a measured quantity.
• Intermediate Check: A periodic check of the measurement instrument to ensure it remains within specified limits between calibrations.

4. References

• Company Metrology SOP [TBD]
• ISO/IEC 17025 traceability via calibration certificates
• ALCOA+ principles

5. Responsibilities

• Technician/Metrology: Perform calibration and document results.
• QC/QA Reviewer: Review calibration documentation for compliance.
• Owner Department: Ensure equipment is available and operational for calibration.
• External Service Provider: Conduct external calibration as per the calibration type.

6. Safety & Preconditions

• Ensure environmental controls are in place (temperature and humidity within specified limits).
• Allow equipment to warm up and stabilize as per manufacturer specifications.
• Maintain cleanliness of the equipment and surrounding area.
• Ensure equipment is level and properly positioned.
• Check power supply and connections prior to calibration.

7. Standards & Tools

• Reference standards required: [TBD]
• Traceability: ISO17025
• Certificate validity check: [TBD]
• Standard ID placeholders: [TBD]

8. Calibration Strategy

The calibration will follow an As Found and As Left logic:

• Minimum number of points: At least 5 points including endpoints and midpoints within the range of 0 to 60 °C/%RH.
• Replicate readings at each point: 3 repeats as a best practice.

9. Step-by-Step Procedure

1. Preparation: Gather all necessary tools and reference standards.
2. Stabilization: Allow the Temperature/RH Data Logger to stabilize in the calibration environment.
3. As Found checks and data capture: Record initial readings at specified points.
4. Adjustment rules: If OOT is found, escalate for adjustment if allowed; otherwise, document and notify QA.
5. As Left verification: Record final readings after any adjustments.
6. Labeling + documentation completion: Complete all required documentation and label the equipment accordingly.

Explicit instruction to record raw observations contemporaneously (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria: ±0.5°C/±3%RH.

Error calculation formula: Error = Observed Value – Reference Value.

Pass/Fail logic: If the error falls within the acceptance criteria, the calibration passes; otherwise, it fails.

Rounding rule placeholder: [TBD]

11. Handling OOT / Failures

• Immediate containment: Tag equipment and stop use.
• Notification & deviation initiation: Notify relevant personnel and initiate deviation process.
• Impact assessment trigger: Define impact window and review of affected results/batches.
• Recalibration after repair/adjustment: Ensure recalibration is performed post-adjustment.
• QA disposition placeholders: [TBD]

12. Records & Retention

• Logbook entries: Document all calibration activities.
• Calibration report/certificate filing: Maintain records in accordance with company policy.
• e-Records if applicable: [TBD]
• Label content requirements: Calibrated date, due date, by whom, status.

13. Annexures

Annexure A: Calibration Data Sheet

Test Points	Reference	Observed	Error	Acceptance	Pass/Fail	As Found	As Left
[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]

Annexure B: Quick Checklist

• Environmental controls verified
• Equipment warm-up completed
• Cleanliness checked
• Leveling confirmed
• Power supply checked

Annexure C: Example Label Text

Calibration Date: [TBD]

Due Date: [TBD]

Calibrated By: [TBD]

Status: [TBD]

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Calibration Protocol

Calibration Protocol

Protocol ID	Asset ID	Equipment Name	Equipment Type	Dept	Area	Process Use	Parameter	Units	Range	Acceptance Criteria	Frequency	Calibration Type	Traceability
[TBD]	CAL-0056	Temperature/RH Data Logger	TempRH Data Logger	Validation	Stability/Storage	Mapping	Temperature/RH	°C/%RH	0 to 60	±0.5°C/±3%RH	365 days	External	ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

• Minimum: 0°C/%RH
• 25%: 15°C/%RH
• 50%: 30°C/%RH
• 75%: 45°C/%RH
• Maximum: 60°C/%RH

Results Table

Test Point	Ref Value	Observed (As Found)	Error	Limit	Pass/Fail	Observed (As Left)	Error	Pass/Fail
0°C/%RH	[TBD]	[TBD]	[TBD]	±0.5°C/±3%RH	[TBD]	[TBD]	[TBD]	[TBD]
15°C/%RH	[TBD]	[TBD]	[TBD]	±0.5°C/±3%RH	[TBD]	[TBD]	[TBD]	[TBD]
30°C/%RH	[TBD]	[TBD]	[TBD]	±0.5°C/±3%RH	[TBD]	[TBD]	[TBD]	[TBD]
45°C/%RH	[TBD]	[TBD]	[TBD]	±0.5°C/±3%RH	[TBD]	[TBD]	[TBD]	[TBD]
60°C/%RH	[TBD]	[TBD]	[TBD]	±0.5°C/±3%RH	[TBD]	[TBD]	[TBD]	[TBD]

Stepwise Instructions

1. Preparation: Ensure the Temperature/RH Data Logger is clean and calibrated prior to use.
2. Stabilization: Allow the equipment to stabilize in the calibration environment for at least 30 minutes.
3. Performing Readings: Take three replicate readings at each test point to ensure accuracy.
4. Calculating Error: Calculate the error for each observed value against the reference value.
5. Evaluation: Compare the calculated errors to the acceptance criteria.
6. Documentation: Record all findings in the results table and ensure data integrity (ALCOA+).

Deviation Instruction for OOT

• Stop use of the equipment immediately.
• Notify the QA department of the out-of-tolerance condition.
• Open a deviation report for the incident.
• Quarantine the impacted results window: [TBD].
• Await QA decision on further actions.

Approvals

Prepared By	Reviewed By	Approved By
[Signature/Date]	[Signature/Date]	[Signature/Date]

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Calibration Checklist

Asset ID	Equipment	Dept	Area	Parameter	Range	Acceptance	Frequency	Traceability
CAL-0056	Temperature/RH Data Logger	Validation	Stability/Storage	Temperature/RH	0 to 60 °C/%RH	±0.5°C/±3%RH	365 days	ISO17025

Pre-calibration

• [ ] Verify environmental conditions are within specified limits
• [ ] Allow equipment to warm up as per manufacturer guidelines
• [ ] Clean the equipment as per SOP
• [ ] Level the equipment if applicable
• [ ] Confirm reference standards are valid and calibrated
• [ ] Ensure logbook is ready for data entry

As Found Execution

• [ ] Set the required setpoints for calibration
• [ ] Perform multiple repeats for accuracy
• [ ] Record all raw data accurately
• [ ] Perform necessary calculations for results

OOT Immediate Actions

• [ ] Tag out the equipment
• [ ] Stop use of the equipment immediately
• [ ] Notify the appropriate personnel
• [ ] Document deviation in the logbook
• [ ] Trigger impact review as per SOP

As Left Verification

• [ ] Conduct post-adjustment checks
• [ ] Confirm all results are within acceptance limits

Documentation & Closure

• [ ] Update equipment label with new calibration date
• [ ] Attach calibration certificate to documentation
• [ ] Obtain reviewer sign-off
• [ ] Update next due date in logbook

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Deviation Impact Assessment

Event Summary
Asset: Temperature/RH Data Logger Date: [TBD] Discovered By: [TBD] Document References: [TBD] As Found Results Summary: [TBD]

Immediate Containment Checklist

• Stop use of the asset
• Label/tag the asset as out of tolerance
• Segregate impacted work

Define Impact Window

Last known in-tolerance date: [TBD] to discovery date: [TBD]

Product/Batch/Test Impact Review

Batch/Study/Report ID	Results Potentially Impacted	Re-test/Re-weigh Decision
[TBD]	[TBD]	[TBD]

Data Integrity Review Prompts (ALCOA+)

• Attributable: [TBD]
• Legible: [TBD]
• Contemporaneous: [TBD]
• Original: [TBD]
• Accurate: [TBD]
• Complete: [TBD]
• Consistent: [TBD]
• Enduring: [TBD]
• Available: [TBD]

Risk Assessment

Severity	Probability	Detectability	Rationale	Overall Risk
[TBD]	[TBD]	[TBD]	[TBD]	[TBD]

Investigation Summary

Root Cause: [TBD]

CAPA Plan

Action	Owner	Due Date	Effectiveness Check
[TBD]	[TBD]	[TBD]	[TBD]

QA Disposition

Release/Hold/Retest/Recall Triggers: [TBD]

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Calibration Certificate

Certificate No: [TBD]

Date: [TBD]

Next Due Date: [TBD]

Asset Details

Asset ID	Equipment Name	Equipment Type	Dept	Area	Make/Model	Serial No	Location	Parameter/Range/Units	Acceptance Criteria
CAL-0056	Temperature/RH Data Logger	TempRH Data Logger	Validation	Stability/Storage	[TBD]	[TBD]	[TBD]	Temperature: 0-60 °C, RH: 0-100 %RH	±0.5°C/±3%RH

Conditions

Environment: [TBD]

Reference Standards

Standard Name/ID	Certificate No	Due Date	Traceability Statement
[TBD]	[TBD]	[TBD]	Traceability to ISO17025

Results

As Found Results

Test Point	Measured Value	Acceptance Criteria	Pass/Fail
Point 1	[TBD]	±0.5°C/±3%RH	[TBD]
Point 2	[TBD]	±0.5°C/±3%RH	[TBD]
Point 3	[TBD]	±0.5°C/±3%RH	[TBD]
Point 4	[TBD]	±0.5°C/±3%RH	[TBD]
Point 5	[TBD]	±0.5°C/±3%RH	[TBD]

As Left Results

Test Point	Measured Value	Acceptance Criteria	Pass/Fail
Point 1	[TBD]	±0.5°C/±3%RH	[TBD]
Point 2	[TBD]	±0.5°C/±3%RH	[TBD]
Point 3	[TBD]	±0.5°C/±3%RH	[TBD]
Point 4	[TBD]	±0.5°C/±3%RH	[TBD]
Point 5	[TBD]	±0.5°C/±3%RH	[TBD]

Measurement Uncertainty Statement: [TBD]

Statement of Conformity: [TBD]

Remarks: [TBD]

Signatures

Performed by: ______________________ Date: __________

Checked by: ______________________ Date: __________

Approved by: ______________________ Date: __________

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