This page documents the boundary of the service, the sources used, public resources for doing the work yourself and alternatives that may be a better fit. It is reasonable to be cautious before sending an internal workbook to a new supplier.
The result is file-specific validation evidence prepared for laboratory review. It is not a certificate and does not establish that every calculation in the workbook passed.
Read this column on the right rather than the one on the left. A list of things I refuse is only useful if it tells you what you are still on the hook for.
| I do not | Which means |
|---|---|
| Decide which contributors your measurement needs | ILAC P14 5.4 calls for relevant short-term contributions, contributions reasonably attributable to the customer's device and applicable contributions used in the CMC evaluation. It does not prescribe one universal list. I report when the customer-device basis is not identifiable from the workbook, but deciding which contributors apply to your measurement remains your laboratory's metrology judgment. |
| Answer 11 of the 47 checks | Your record arrives with blanks in it: backups, password handling, macro behaviour, whether the correct procedure was chosen. It is not a finished document until you complete those. I leave them visible rather than filling them in, because no examination of a file can answer them. |
| Test macros, buttons, or printed output | GLP 15 section E leaves those to the laboratory and so do I. I detect that macros are present; I do not run them or judge whether they work. |
| Know what your workbook was meant to do | Section 3 of the record is a requirements specification I reverse-derived from the file when you do not supply one. If it misstates your intent, every test below it is measuring against the wrong specification. Reading that section is the one step you cannot delegate to me, and it is the single most important thing on this page. |
Modify the legacy .xls file you send |
I make a separate .xlsx working copy with Microsoft Excel or
LibreOffice because the analysis library does not read .xls
directly. Your original stays unchanged. The record identifies both files by
hash, names the conversion tool and states that the converted copy was the file
examined. Macro and button behaviour remains assigned to the laboratory. |
| Validate your LIMS | Waters, LabWare and LabLynx do that and they are good at it. I work on the side workbooks that feed it, which is a different problem. |
| Work under 21 CFR Part 11 or pharma CSV | Different regulator, different liability, much heavier documentation. If that is your world, see section 5. |
| Certify, attest, approve, or accredit anything | Desrochers Validation is not accredited, and this record is not presented as accreditation, certification or approval. Your technical manager reviews the evidence, confirms the intended requirements and decides whether to authorize the workbook for use. |
| Predict what your assessor will conclude | I do not control your assessor and cannot guarantee an assessment outcome. |
| Give an opinion on results you already issued | I validate software and do not issue a conformity conclusion about released results. If a finding may affect previous results, I report it confidentially to your laboratory contact. Your laboratory determines the investigation, correction and notification required by its management system. |
| Have a track record | No record I have produced has been through an accreditation assessment yet. I started in 2026. Being able to complete a NIST form is not the same as your assessor accepting it, and I have no evidence about the second thing. That is the honest reason the first file is free. |
Potentially consequential findings are handled confidentially with the laboratory contact. The laboratory decides the investigation, correction and notification steps required by its own management system.
The table distinguishes primary requirements and guidance from secondary background material so you can check the basis of the method.
| Claim | Source | Kind |
|---|---|---|
| Uncertainty must be evaluated for each measurement function | ISO/IEC 17025:2017 clause 7.6. The standard is not free to redistribute, so I describe what it requires in my own words rather than quoting its text. The method I actually test against is the GUM, below, which is free and public. | Paid standard |
| How an uncertainty budget is built and combined | JCGM 100:2008, the GUM, free from BIPM. It supplies the uncertainty framework used by the supported calculations; workbook implementations vary. | Primary, free |
| Expanded uncertainty to at most two significant figures; coverage factor and coverage probability both stated | ILAC P14, free. A2LA's R205 defers to it. | Primary, free |
| NIST OWM publishes a per-file software quality-assurance form | NIST GLP 15, and NIST IR 8250. GLP 15 is an Office of Weights and Measures procedure. I use its 47-item form as the record structure; I do not claim every ISO/IEC 17025 assessor requires that particular form. | Primary, free |
| Your accreditation scope and the range in my first email | Your own certificate in the A2LA public directory, with the date I retrieved it recorded. | Primary, free |
Several core references are free. The ISO standard requires licensed access, and NIST training may have a fee. If you have the time and appropriate technical judgment, here is a practical starting path.
The work requires time to document requirements, derive independent expected results, execute tests and record what remains unresolved. The service is an option for laboratories that do not want to build and maintain that process internally.
The record is built around the NIST Office of Weights and Measures Software Verification and Validation form, published as GLP 15 (2019), Appendix A.
Of its 47 checks, 30 are designed to use evidence from the file, 6 gather file evidence and leave the judgment to you, and 11 only you can answer. A check is answered from the file only when that file establishes the whole claim. Every check appears in the record, including those the service cannot answer.
| Check | What it asks | Who answers it |
|---|---|---|
| A1 | Spreadsheet is clear and makes sense | I gather the evidence, you judge it |
| A2 | There are instructions for use | I assess it from the file when the required evidence is present |
| A3 | Instructions and data input appear on the visible portion of the first worksheet | I assess it from the file when the required evidence is present |
| A4 | Data-entry fields are labeled and color coded (avoiding red and green) | I assess it from the file when the required evidence is present |
| A5 | The Standard Operating Procedure used is clearly specified | I assess it from the file when the required evidence is present |
| A6 | The number of digits to be rounded to is specified | I assess it from the file when the required evidence is present |
| A7 | The user is warned whenever data-entry fields are left blank | I assess it from the file when the required evidence is present |
| A8 | Data-entry fields are blank when opened, so old data is not reused | I assess it from the file when the required evidence is present |
| A9 | The software opens at the right location within the file | I assess it from the file when the required evidence is present |
| A10 | Unused fields/cells are locked | I assess it from the file when the required evidence is present |
| A11 | Rows/columns the operator need not see are hidden | I gather the evidence, you judge it |
| A12 | Unused sheets are removed | I assess it from the file when the required evidence is present |
| A13 | Worksheets are named appropriately | I assess it from the file when the required evidence is present |
| Check | What it asks | Who answers it |
|---|---|---|
| B1 | The correct SOP is used | Only you can answer it |
| B2 | The formulae and methods chosen from that SOP are specified | I assess it from the file when the required evidence is present |
| B3 | Sources and references for formulae are specified | I assess it from the file when the required evidence is present |
| B4 | The SOP, its methods and formulae are appropriate to the level of precision | Only you can answer it |
| Check | What it asks | Who answers it |
|---|---|---|
| C1 | The formulae in the fields exactly match the procedure | Only you can answer it |
| C2 | Repeated calculations appropriately reference the correct cells | I assess it from the file when the required evidence is present |
| C3 | Calculations, tested with reference data, show appropriate accuracy | I assess it from the file when the required evidence is present |
| C4 | Rounding is done at the appropriate locations in the file | I assess it from the file when the required evidence is present |
| Check | What it asks | Who answers it |
|---|---|---|
| D1 | Calculations are stable with large numbers and small differences | I assess it from the file when the required evidence is present |
| D2 | Fields are categorized as Number and not General when appropriate | I assess it from the file when the required evidence is present |
| D3 | Number cells are locked to an appropriate number of decimal places | I assess it from the file when the required evidence is present |
| Check | What it asks | Who answers it |
|---|---|---|
| E1 | Conditional logic cells handle negative values properly | I assess it from the file when the required evidence is present |
| E2 | Conditional logic cells withstand a boundary value test | I assess it from the file when the required evidence is present |
| E3 | Each macro used is functional | Only you can answer it |
| E4 | Each command/button is functional | Only you can answer it |
| E5 | Combinations of interdependent macros are functional | Only you can answer it |
| E6 | Plotted graphs are accurate | I gather the evidence, you judge it |
| E7 | Plotted graphs and their axes are properly labeled | I assess it from the file when the required evidence is present |
| E8 | Worksheets/reports print properly, if needed to | I assess it from the file when the required evidence is present |
| E9 | Conditional (color and non-color) formatting is functional | I gather the evidence, you judge it |
| Check | What it asks | Who answers it |
|---|---|---|
| F1 | Look-up tables and lists match the latest calibration report | Only you can answer it |
| F2 | Uncertainties match the latest Scope | I assess it from the file when the required evidence is present |
| F3 | Values that reference another workbook are dated | I assess it from the file when the required evidence is present |
| F4 | Behaviour is as intended when a master list's date is updated | I gather the evidence, you judge it |
| Check | What it asks | Who answers it |
|---|---|---|
| G1 | Embedded data (conversion factors, reference values) is correct | I gather the evidence, you judge it |
| G2 | The evaluation of the embedded data is dated and documented | I gather the file evidence; you confirm the evaluation record |
| Check | What it asks | Who answers it |
|---|---|---|
| H1 | Newer and older spreadsheets agree down to intermediate calculations, dated | I assess it from the file when the required evidence is present |
| Check | What it asks | Who answers it |
|---|---|---|
| I1 | Hand calculations agree with the spreadsheet, or differ insignificantly | I assess it from the file when the required evidence is present |
| Check | What it asks | Who answers it |
|---|---|---|
| J1 | Equation and calculation cells are protected against inadvertent editing | I assess it from the file when the required evidence is present |
| J2 | Cells are locked in place and cannot be moved or dragged | I assess it from the file when the required evidence is present |
| J3 | Confidentiality of passwords is appropriate | Only you can answer it |
| J4 | Files are backed up automatically | Only you can answer it |
| J5 | Additional back-up is available at alternate facilities | Only you can answer it |
| J6 | Files on network drives cannot be accidentally deleted | Only you can answer it |
Go to them, not me, if you do not have an uncertainty budget yet. They build budgets; I document and verify budgets you already have. Different product, same reader. isobudgets.com.
Sells an Equipment Uncertainty Calculation Excel template with a guide. It is a tool for building a budget, not a validation of an existing workbook. Check its current product page before purchasing. uncera.com.
If you are FDA-regulated, I am the wrong supplier and you should not hire me. Ofni Systems sells ExcelSafe, which adds audit trails and electronic signatures to Excel, and does validation packages around it. That world requires different controls and documentation because the regulator is different. ofnisystems.com.
A general consultant offers a broader engagement and may make the metrology judgments I explicitly refuse to make, write your quality manual and support an assessment. If what you actually need is someone to decide what belongs in your budget, hire one of them.
Central-system validation is a different engagement. If you need validation of a LIMS rather than evidence for individual Excel calculation files, use a supplier that specializes in that system.
Sometimes the right answer. This service is most useful when important Excel calculation files lack current, file-specific evidence. The number of scope lines does not by itself determine the number of workbooks or budgets.