How it works Documents Data integrity
Self-service · Computerised system validation

Validate your Excel calculation sheets yourself

Upload a spreadsheet and Molgenium guides you through the whole validation lifecycle: gap assessment, specification, risk assessment, a hardened template, an IQ/OQ protocol with independently calculated expected results, execution, the validation report, periodic review and change control.

How it works

From an uncontrolled sheet to a released, validated template

Every step happens on this website. You stay in control of the decisions; the tool does the analysis, the calculations and the paperwork.

Register

Record the spreadsheet in your inventory with its owner, GxP impact, storage location and intended use.

Analyse

Upload the workbook. Every formula is read, inputs and outputs are found, and a GMP gap assessment flags unprotected formulas, hard-coded constants, inconsistent formulas, external links and macros.

Specify

Confirm the drafted specification: inputs with units and allowed ranges, outputs with decimals, and every calculation explained in words.

Assess risk

GxP impact and complexity set the risk level, the depth of testing and the periodic review interval.

Harden

Download a protected template: locked formulas, validated inputs, document control in header and footer, and a checksum.

Protocol

IQ and OQ tests are generated with expected results calculated by Molgenium’s own formula engine, independently of Excel.

Execute

Run the tests and record the results. Read calculation results straight from your saved workbook and verify the installed file by its checksum.

Report

Deviations, traceability matrix and conclusion are compiled into the validation summary report for approval and release.

Operate

Periodic reviews, change control with automatic formula comparison, retirement and a complete audit trail.

Documents

The validation file, ready to sign

Gap assessment

Findings with severity, affected cells and your response.

User and functional specification

Intended use, inputs, outputs and calculations with requirement IDs.

Risk assessment

Risk level, rationale, hazards and controls.

IQ/OQ protocol

Pre-approval page, tests with expected results and blank fields for paper execution.

Executed protocol

Actual results, pass/fail, evidence and deviations.

Validation summary report

Traceability matrix, deviations, conclusion and release.

Periodic review and change records

Review checklists, change requests with formula differences, retirement.

Audit trail

Every action with user and time, append-only.

Data integrity

Built the way an inspector would expect

Independent expected results

Expected values are recalculated by a separate formula engine, so the test does not rely on Excel checking itself.

Checksums

Uploaded files and templates are identified by SHA-256, and installed copies can be verified against the approved template at any time.

Audit trail

Creation, edits, approvals, file uploads and printouts are logged with user and time. Entries cannot be changed or deleted.

Your data

Workbooks are read and hardened in your browser. Projects and files are stored in your Molgenium account and are visible only to you. Protection passwords are never stored.

Molgenium Spreadsheet Validation supports your validation; responsibility for the validated state stays with your quality unit. Approvals recorded in the tool are not electronic signatures under 21 CFR Part 11 or EU GMP Annex 11: sign the printed documents under your QMS. Functions outside the independent engine are flagged for manual verification.