LIMS Validation Record

Appendix number: 11-App-06
Parent procedure: Procedure 11 — Quality Assurance

Instructions

Complete one record per software system per validation event (initial validation, re-validation after update, periodic verification). File in quality records and reference in the LIMS Validation Register (Appendix 11-App-05).

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Section A — System Identification

Field	Entry
Validation record number	[e.g., VR-LIMS-001]
Software system	[e.g., LabWare LIMS]
Version	[e.g., 7.4.2]
Vendor	[e.g., LabWare Inc.]
Installation environment	[e.g., Server: Windows Server 2022, SQL Server 2019; Clients: Windows 11]
Risk category	[High / Medium / Low]
Validation type	[Initial / Re-validation (reason: ___) / Periodic verification]
Validation date(s)	[Start – End]
Validated by	[Name(s)]

Section B — Requirements Specification

List the functional requirements to be tested. For re-validations or periodic verifications, list only the requirements affected by the change or selected for re-verification.

Req. ID	Functional requirement	Risk to result validity	Test case ref(s).
R-01	[e.g., System assigns unique, sequential sample IDs that cannot be duplicated]	[e.g., Sample mix-up → wrong results reported]	[TC-01]
R-02	[e.g., Concentration calculated from calibration curve matches independent manual calculation within rounding tolerance]	[e.g., Incorrect result reported]	[TC-02, TC-03]
R-03	[e.g., Data transfer from ICP-OES software to LIMS preserves all decimal places and units]	[e.g., Truncation or unit error in reported result]	[TC-04]
R-04	[e.g., Dilution correction applied correctly using the factor entered at sample registration]	[e.g., Incorrect final concentration]	[TC-05]
R-05	[e.g., Results rounded to the number of significant figures specified in the method SOP]	[e.g., Incorrect precision in reported result]	[TC-06]
R-06	[e.g., Audit trail records every data entry, modification, and deletion with user, timestamp, original value, new value, and reason]	[e.g., Undetected data manipulation]	[TC-07, TC-08]
R-07	[e.g., Role-based access prevents analysts from approving reports or modifying locked records]	[e.g., Unauthorized approval or data modification]	[TC-09]
R-08	[e.g., Test report assembles correct sample ID, method, results, units, uncertainty, and approval signatures]	[e.g., Incorrect report issued to customer]	[TC-10]
R-09	[e.g., Backup restores all data and configuration without loss]	[e.g., Data loss after system failure]	[TC-11]

Section C — Test Cases and Results

TC ref.	Req. ID	Test description	Input / precondition	Expected result	Actual result	Pass / Fail	Tester	Date	Notes
TC-01	R-01	[Attempt to register two samples with the same ID]	[Register sample S-001; attempt to register another as S-001]	[System rejects duplicate; assigns next sequential ID]	[___]	[___]	[___]	[___]
TC-02	R-02	[Verify ICP-OES Ni concentration calculation]	[Enter known intensities: std1=1000, std2=5000, std3=10000 counts at known concentrations; sample=7500 counts]	[Concentration = X.XXX mg/L (independently calculated)]	[___]	[___]	[___]	[___]
TC-03	R-02	[Verify Karl Fischer moisture calculation]	[Enter known titration volume, reagent factor, sample mass]	[Moisture = X.XXX % (independently calculated)]	[___]	[___]	[___]	[___]
TC-04	R-03	[Verify data transfer from ICP-OES to LIMS]	[Export 10-sample result set from ICP Expert; import into LIMS]	[All values match source file exactly — same decimal places, units, sample IDs]	[___]	[___]	[___]	[___]
TC-05	R-04	[Verify dilution correction]	[Sample registered with dilution factor 50; measured concentration 2.345 mg/L]	[Reported concentration = 117.25 mg/L (= 2.345 × 50)]	[___]	[___]	[___]	[___]
TC-06	R-05	[Verify rounding]	[Result = 33.3549% Ni; SOP specifies 2 decimal places]	[Report shows 33.35% Ni]	[___]	[___]	[___]	[___]
TC-07	R-06	[Verify audit trail on data entry]	[Enter result 33.35%; then modify to 33.40% with reason "transcription error"]	[Audit trail shows: original=33.35%, new=33.40%, user=[name], timestamp, reason="transcription error"]	[___]	[___]	[___]	[___]
TC-08	R-06	[Verify audit trail cannot be deleted]	[Attempt to delete or modify an audit trail entry]	[System prevents deletion/modification of audit trail]	[___]	[___]	[___]	[___]
TC-09	R-07	[Verify access control]	[Log in as Analyst role; attempt to approve a test report]	[System rejects — insufficient privileges]	[___]	[___]	[___]	[___]
TC-10	R-08	[Verify report assembly]	[Complete a full sample workflow (registration → analysis → QC pass → report); compare report output against raw data]	[All fields correct: sample ID, method, results, units, uncertainty, dates, approvals]	[___]	[___]	[___]	[___]
TC-11	R-09	[Verify backup/restore]	[Restore database from most recent backup to test environment]	[All records present and correct; no data loss; application functions normally]	[___]	[___]	[___]	[___]

Section D — Summary and Conclusion

Field	Entry
Total test cases	[n]
Passed	[n]
Failed	[n]
Failures resolved?	[Yes — describe resolution / No — describe risk mitigation and timeline]
Conclusion	[e.g., "All test cases passed. The system is validated for routine use." / "X test cases failed; corrective action taken; re-testing passed. The system is validated for routine use with the following restriction: ___"]

Validated by: [Name, date]
Approved by: [Technical Manager, date]

Section E — Re-validation and Periodic Verification Log

Use this section to record subsequent re-validations or periodic verifications performed on this system.

Date	Trigger	Test cases executed	Results	Conclusion	Performed by	Approved by
[Date]	[e.g., Software update to v7.4.3]	[e.g., TC-02, TC-04, TC-05, TC-06, TC-10 — calculation and data transfer tests]	[e.g., All passed]	[e.g., Validated status maintained]	[Name]	[Technical Manager]
[Date]	[e.g., Annual periodic verification]	[e.g., TC-02, TC-04, TC-06, TC-07, TC-11]