Assay SOP Version Control (GMP / 21 CFR Part 11)
Git-style version control for assay SOPs — track every revision, change summary, author and sign-off, tuned for a GMP-regulated lab. Private and offline.
Keep an immutable, dated history of every assay SOP — each version records what changed, who changed it and its sign-off status. Built for assay-development teams who need an immutable, sign-off-controlled audit trail. Nothing leaves your browser, so even unpublished methods stay confidential.
Tip: bump the minor version (v1.1 → v1.2) for small edits and the major version (v2.0) for changes that affect results. Export to CSV for your QMS or an audit.
For research / operational use only. Not a medical device and not a substitute for validated clinical systems or professional medical judgement. Verify against your trial protocol, IRB/ethics approval and applicable regulations (GCP, 21 CFR Part 11, HIPAA/GDPR).
Free assay SOP version control and change-log for a GMP-regulated lab: track revisions, sign-offs and an audit trail entirely in your browser.
About Assay SOP Version Control (GMP / 21 CFR Part 11)
A free, offline assay SOP version-control tool for assay-development teams. Keep an immutable, dated history of every assay SOP — each version records what changed, who changed it and its sign-off status. Built for assay-development teams who need an immutable, sign-off-controlled audit trail. Nothing leaves your browser, so even unpublished methods stay confidential.
How to use Assay SOP Version Control (GMP / 21 CFR Part 11)
- 1Add v1.0 of your assay SOP with a short description of the method (e.g. an ELISA or cell-viability assay).
- 2Each time you change it, log a new version with a change summary, your name and the date — never overwrite the old one.
- 3Set the status as it moves through Draft / QA review / Approved / Effective / Retired, and export the full history to CSV for your records or QMS.
Why use Assay SOP Version Control (GMP / 21 CFR Part 11)?
- ✓Assay SOPs evolve constantly — this gives assay-development teams a Git-style history so you always know which version produced which result.
- ✓Each entry captures a change summary, author, date and sign-off status (Draft → QA review → Approved…), giving a GMP-regulated lab an immutable, sign-off-controlled audit trail.
- ✓Supports a Part-11-style mindset: dated, attributable, never-overwritten records you can export for an inspector.
Frequently asked questions
Why use version control for a assay SOP?+
Methods drift over time, and a result is only reproducible if you know exactly which version of the assay SOP produced it. Version control gives every revision a number, a change summary and an author, so you can reproduce old work, justify changes to reviewers, and onboard new assay-development teams without losing institutional knowledge.
How should I number protocol versions?+
A simple semver-style scheme works well: bump the minor number (v1.1 → v1.2) for small edits like a reagent swap, and the major number (v1.x → v2.0) for changes that could affect results, such as a new incubation time or instrument. Record the rationale in the change summary so the jump is self-explanatory at audit.
Is this an electronic lab notebook (ELN)?+
It is a lightweight, offline version-control log rather than a full ELN — but it captures the part that matters most for reproducibility: a dated, attributable, immutable history of every change to a assay SOP. You can export to CSV and attach it to your ELN or QMS at any time.
Where is my data stored?+
Entirely in your browser's localStorage — no sign-up, no upload, no server. That keeps proprietary methods and unpublished IP private and means the tool works offline, which is exactly what a GMP-regulated lab needs.
Related tools
- Library-Prep Protocol Version Control (GMP / 21 CFR Part 11)
- Cleaning-Validation SOP Version Control (GMP / 21 CFR Part 11)
- Tissue-Dissociation Protocol Version Control (GMP / 21 CFR Part 11)
- Reagent Recipe Version Control (Multi-site)
- QPCR Assay Protocol Version Control (Multi-site)
- Sample-Prep Protocol Version Control (Multi-site)
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