Date: 1-JANUARY-2015 Last Updated: 15-AUGUST-2026
Overview
Chemical Solutions™ HSQ™ (High Sensitivity Qualification) and PQ™ (Performance Qualification) Kits include Excel™ templates designed to assist laboratories with qualification calculations, documentation, and reporting.
These spreadsheets are provided as validated tools that support the qualification process and help standardize calculation procedures across instrument qualification activities. When used in their original form, users are not required to perform an independent validation of the spreadsheet calculations.
Validation Scope
The supplied Excel™ templates have undergone validation to verify that:
- Calculations perform as intended
- Formulas generate accurate results
- Spreadsheet functionality operates correctly
- Worksheets support the intended qualification activities
- Data processing functions remain consistent
The validation applies to the original, unmodified version of the spreadsheet.
User Responsibilities
While the spreadsheet calculations have been validated, the quality of the final results depends on the accuracy of the data entered by the user.
Users remain responsible for:
- Accurate data entry
- Correct transfer of instrument results
- Verification of source data
- Compliance with internal procedures
- Review of final qualification reports
A validated spreadsheet cannot compensate for incorrect or incomplete input values.
Spreadsheet Protection
To preserve validation status, the qualification templates are protected against unauthorized modification.
Protection helps prevent changes to:
- Calculation formulas
- Embedded functions
- Validation logic
- Report structures
This safeguards the integrity of the qualification calculations and helps maintain consistency between users and laboratories.
Effect of Spreadsheet Modifications
The validation status applies only to the original spreadsheet configuration.
If protected cells, formulas, or calculation structures are altered:
- The original validation no longer applies.
- The user assumes responsibility for any modified calculations.
- Internal validation may become necessary.
- Additional quality review may be required.
For this reason, modification of protected worksheet elements is generally not recommended.
Validation Documentation
Validation documentation is available to support laboratories that require evidence of spreadsheet qualification.
Documentation may be useful for:
- Internal audits
- Regulatory inspections
- Supplier qualification programs
- Quality Management Systems
- Validation record files
A validation certificate can be provided when documentation is required by a laboratory's quality organization.
Benefits of Validated Templates
Using validated qualification templates can help:
- Improve consistency
- Reduce manual calculations
- Simplify documentation
- Standardize reporting
- Support audit readiness
- Reduce qualification effort
These benefits can assist laboratories in maintaining efficient qualification programs.
Key Takeaways
- HSQ™ and PQ™ Qualification Kit spreadsheets are provided as validated tools.
- Independent validation is not required when the templates are used as supplied.
- Validation covers spreadsheet design, functionality, and calculations.
- Accurate user data entry remains essential.
- Spreadsheet protection helps preserve validation status.
- Modifications to protected calculations void the original validation.
- Validation certificates are available for laboratories requiring supporting documentation.
Additional Resources
For qualification standards, validated calculation tools, compliance documentation, and performance verification resources, view:
For spreadsheet validation documentation and supporting qualification records, view: