Desrochers Validation, Félix Desrochers Back to the offer

What I don't do, and where to check everything I claim

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.

1. What the service establishes

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.

2. What the service does not establish

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 notWhich 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.

3. What happens to your file

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.

4. Standards, sources and self-service resources

Where every claim comes from

The table distinguishes primary requirements and guidance from secondary background material so you can check the basis of the method.

ClaimSourceKind
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

Public resources for doing much of this work yourself

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.

  1. Download the form. NIST GLP 15. Appendix A is the checklist used as the record's organizing structure.
  2. Download the GUM. JCGM 100:2008. Sections 4.2 to 4.3 cover Type A and Type B evaluation, 5.1.2 the combination rule, 6.2 coverage factors. Those four sections are most of what matters.
  3. Read ILAC P14 section 5 for the calibration-certificate uncertainty reporting rules, including the limit of two significant digits for expanded uncertainty.
  4. Consider the NIST training. NIST OWM runs the paid course Software Verification and Validation, Parts I and II, focused on Excel software quality assurance in calibration laboratories.
  5. Use NIST's own templates and NIST Technical Note 1297 for worked uncertainty guidance.
  6. Review A2LA's public requirements and guidance at portal.a2la.org/documents for the documents A2LA makes available to laboratories and assessors.

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.

5. The complete NIST GLP 15 checklist

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.

Show all 47 checks

A. Software Inspection

CheckWhat it asksWho answers it
A1Spreadsheet is clear and makes senseI gather the evidence, you judge it
A2There are instructions for useI assess it from the file when the required evidence is present
A3Instructions and data input appear on the visible portion of the first worksheetI assess it from the file when the required evidence is present
A4Data-entry fields are labeled and color coded (avoiding red and green)I assess it from the file when the required evidence is present
A5The Standard Operating Procedure used is clearly specifiedI assess it from the file when the required evidence is present
A6The number of digits to be rounded to is specifiedI assess it from the file when the required evidence is present
A7The user is warned whenever data-entry fields are left blankI assess it from the file when the required evidence is present
A8Data-entry fields are blank when opened, so old data is not reusedI assess it from the file when the required evidence is present
A9The software opens at the right location within the fileI assess it from the file when the required evidence is present
A10Unused fields/cells are lockedI assess it from the file when the required evidence is present
A11Rows/columns the operator need not see are hiddenI gather the evidence, you judge it
A12Unused sheets are removedI assess it from the file when the required evidence is present
A13Worksheets are named appropriatelyI assess it from the file when the required evidence is present

B. Mathematical Specification

CheckWhat it asksWho answers it
B1The correct SOP is usedOnly you can answer it
B2The formulae and methods chosen from that SOP are specifiedI assess it from the file when the required evidence is present
B3Sources and references for formulae are specifiedI assess it from the file when the required evidence is present
B4The SOP, its methods and formulae are appropriate to the level of precisionOnly you can answer it

C. Code Review

CheckWhat it asksWho answers it
C1The formulae in the fields exactly match the procedureOnly you can answer it
C2Repeated calculations appropriately reference the correct cellsI assess it from the file when the required evidence is present
C3Calculations, tested with reference data, show appropriate accuracyI assess it from the file when the required evidence is present
C4Rounding is done at the appropriate locations in the fileI assess it from the file when the required evidence is present

D. Numerical Stability

CheckWhat it asksWho answers it
D1Calculations are stable with large numbers and small differencesI assess it from the file when the required evidence is present
D2Fields are categorized as Number and not General when appropriateI assess it from the file when the required evidence is present
D3Number cells are locked to an appropriate number of decimal placesI assess it from the file when the required evidence is present

E. Component Testing

CheckWhat it asksWho answers it
E1Conditional logic cells handle negative values properlyI assess it from the file when the required evidence is present
E2Conditional logic cells withstand a boundary value testI assess it from the file when the required evidence is present
E3Each macro used is functionalOnly you can answer it
E4Each command/button is functionalOnly you can answer it
E5Combinations of interdependent macros are functionalOnly you can answer it
E6Plotted graphs are accurateI gather the evidence, you judge it
E7Plotted graphs and their axes are properly labeledI assess it from the file when the required evidence is present
E8Worksheets/reports print properly, if needed toI assess it from the file when the required evidence is present
E9Conditional (color and non-color) formatting is functionalI gather the evidence, you judge it

F. Numerical Reference Results

CheckWhat it asksWho answers it
F1Look-up tables and lists match the latest calibration reportOnly you can answer it
F2Uncertainties match the latest ScopeI assess it from the file when the required evidence is present
F3Values that reference another workbook are datedI assess it from the file when the required evidence is present
F4Behaviour is as intended when a master list's date is updatedI gather the evidence, you judge it

G. Embedded Data Evaluation

CheckWhat it asksWho answers it
G1Embedded data (conversion factors, reference values) is correctI gather the evidence, you judge it
G2The evaluation of the embedded data is dated and documentedI gather the file evidence; you confirm the evaluation record

H. Back-to-Back Testing

CheckWhat it asksWho answers it
H1Newer and older spreadsheets agree down to intermediate calculations, datedI assess it from the file when the required evidence is present

I. Analysis Without Computer Assistance

CheckWhat it asksWho answers it
I1Hand calculations agree with the spreadsheet, or differ insignificantlyI assess it from the file when the required evidence is present

J. Security

CheckWhat it asksWho answers it
J1Equation and calculation cells are protected against inadvertent editingI assess it from the file when the required evidence is present
J2Cells are locked in place and cannot be moved or draggedI assess it from the file when the required evidence is present
J3Confidentiality of passwords is appropriateOnly you can answer it
J4Files are backed up automaticallyOnly you can answer it
J5Additional back-up is available at alternate facilitiesOnly you can answer it
J6Files on network drives cannot be accidentally deletedOnly you can answer it

6. Alternatives and when to use them

ISOBudgets

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.

The 17025 Store, now trading as Uncera

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.

Pharma and 21 CFR Part 11 specialists

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 ISO 17025 consultant

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.

LIMS validation vendors

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.

Doing nothing

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.