LIMS Validation Register

Appendix number: 11-App-05
Parent procedure: Procedure 11 — Quality Assurance

Instructions

List every software system that captures, processes, transfers, calculates, stores, or reports laboratory data. Maintain the register as a controlled document per Procedure 00. Review at least annually and update whenever a new system is introduced, a system is upgraded, or a system is decommissioned.

Register

Entry	Software system	Version	Vendor / developer	Risk category	Functions affecting result validity	Validation record ref.	Validation date	Validated by	Next periodic verification	Status
1	[e.g., LabWare LIMS]	[e.g., 7.4.2]	[e.g., LabWare Inc.]	[High]	[Sample registration, result entry, calculations, report generation, audit trail, data storage]	[e.g., VR-LIMS-001]	[Date]	[Technical Manager]	[Date + 1 year]	[Validated / Pending / Re-validation required]
2	[e.g., Agilent ICP Expert]	[e.g., 7.4]	[e.g., Agilent Technologies]	[High]	[Calibration curve fitting, concentration calculation, internal standard correction, QC evaluation]	[e.g., VR-ICP-001]	[Date]	[Technical Manager]	[Date + 1 year]
3	[e.g., Metrohm Tiamo]	[e.g., 2.5]	[e.g., Metrohm AG]	[High]	[Karl Fischer endpoint detection, moisture calculation, drift compensation]	[e.g., VR-KF-001]
4	[e.g., Malvern Mastersizer software]	[e.g., 3.82]	[e.g., Malvern Panalytical]	[High]	[Particle size distribution calculation, optical model application, result statistics (D10, D50, D90)]	[e.g., VR-PSD-001]
5	[e.g., Micromeritics SmartVacPrep / ASAP software]	[e.g., 5.03]	[e.g., Micromeritics]	[High]	[BET isotherm fitting, surface area calculation, degas monitoring]	[e.g., VR-BET-001]
6	[e.g., Agilent OpenLab CDS]	[e.g., 2.7]	[e.g., Agilent Technologies]	[High]	[Chromatographic integration, calibration, quantification, system suitability]	[e.g., VR-HPLC-001]
7	[e.g., MU Budget spreadsheet — ICP-OES]	[e.g., Rev 01]	[In-house]	[Medium]	[Measurement uncertainty calculation for ICP-OES results]	[e.g., VR-SS-001]
8	[e.g., Calibration curve checker — Excel]	[e.g., Rev 00]	[In-house]	[Medium]	[Independent verification of LIMS calibration curve calculations]	[e.g., VR-SS-002]

Change Log

Date	Entry	Change description	Impact assessment	Re-validation required?	Re-validation record ref.	Approved by
[Date]	[e.g., 1]	[e.g., LIMS updated from v7.4.1 to v7.4.2 — vendor patch for report formatting]	[e.g., Report output affected; calculations unchanged]	[e.g., Partial — report format test cases only]	[e.g., VR-LIMS-001-R1]	[Technical Manager]

Decommissioned Systems

Software system	Final version	Date decommissioned	Reason	Validation records retained until
[e.g., Legacy LIMS X]	[e.g., 3.2]	[Date]	[e.g., Replaced by LabWare LIMS]	[Date + 5 years]