MicroStats

2026-03-13 · Recorded voicenote — the decision to replace CombiStats with self-built, GMP-validated software (private archive)

1. The world before

   The QC microbiology lab at Venus Remedies ran Enoxaparin potency statistics — Anti-factor Xa and Anti-factor IIa — on two systems: CombiStats, EDQM's licensed statistical software, and an internally validated Excel workbook. The workbook produced correct answers and lived in the zone every GMP practitioner recognizes: validated on paper, fragile in practice. Manual cell references. No audit trail. One silent paste-error away from broken.

2. One day

   Mid-March 2026. A voicenote, recorded before my rational brain could talk me out of it: convert that Excel into real, GMP-validated software. Same purpose and workflow as CombiStats. Validated against the Excel itself. Auditable by design. The instruction I gave myself: act and think like a GMP auditor. I had never built GMP-compliant software before.

3. Because of that

   1. 13 March 2026. A two-to-three-day build. The statistics re-derived from first principles — LOG10 linear regression, geometric-mean potency, R squared as the system-suitability gate — because 'I think I remember this' is not a GMP defense. Below 0.98, the system refuses to proceed. Not a warning; a stop.
   2. The regulatory framework learned from scratch: GAMP 5, EU GMP Annex 11, 21 CFR Part 11 — each read twice, once as a developer and once as an imaginary auditor.
   3. Claude Code as pair-programmer throughout. The design, workflow logic, validation decisions, and statistical approach were mine; Claude Code wrote the code I directed. Node.js, SQLite, hosted on Railway. The architecture is not complicated. The discipline behind it is.
   4. Shadow verification: every result computed by a second, entirely independent calculation pathway, the two agreeing to within 1e-9. If they disagree, the result does not exist. Draft, Submitted, Final lifecycle, Doer / Approver / Administrator roles held separate, immutable audit trail with SHA-256 tamper evidence, admin portal logging every session and update.
   5. The validation documentation written for this software, this lab, this workflow — URS, FS, DS, IQ, then OQ and PQ — plus the user manual. Not delegated. Not adapted from a template.
   6. A first demo at home landed flat; the math was questioned. That sting became fuel — by the time the team's calculation owner ran his independent verification on the live system, there was no gap to find.

4. Until finally

   The system went live in the GMP environment and the microbiology team entered more than 15 real Enoxaparin assays. Prince, the calculation owner, independently verified the math — identically. MicroStats was formally GMP-implemented in QC Micro. Then the designer's pass: the generated report redesigned with a Venus-emblem banner and signatures rendered in Dancing Script — blue for the lab analyst, black for the QC approver — so a digital report reads as signed, not stamped. It now runs alongside CombiStats for this workflow at a saving of over 600 euros per year.

5. Since then

   MicroStats became the proof-of-pattern — Kura, Granth, and Dwaar followed, a wave of disciplined, personalized software at Venus. The validated-calculation approach was later generalized into the SanctumQMS LIMS calculation engine, and the company's technical team adopted GMP-oriented software development into its 2026 mission. The software is still maintained: a recent pull request corrected a single validation-document reference (PQ-07, Format No. F/QC/546/01-00) with exactly the precision the original build demanded. The maintenance record is part of the proof.