GxP SOP authoring that ties every step to the regulation or change it answers to
Every SOP current with the regulations it answers to, every step tied to its source.
See one case, screen by screen ↓Software that drafts and updates the standard operating procedures a GMP site runs on, from the regulations and site changes they answer to. GxP SOP Authoring adds five agents that read a new clause, find every SOP step it touches, draft the revised steps in your template with a source beside each one and list who must retrain — for quality to review, approve and sign.
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A sterile site runs on its SOPs — Veltara's Aldenbrook site in the working solution has 1,486 of them. When a regulation moves, like the draft revision of EU GMP Annex 11, which asks for audit trail review before batch release, quality has to find every procedure and every step that answers to it, rewrite those steps in the site template, get them approved and retrain the people who do the work. Today that is a consultant, a keyword search and a spreadsheet that lists documents, not steps.
Keyword search misses the steps that implement a requirement without naming it: “Review alarm acknowledgements quarterly” never says “audit trail”. Steps with no traceable reason stay in place — “Allow 2 working days for the review” — and nobody knows whether they are a requirement or a habit. The SOPs that lag behind surface at inspection, where written procedures are among the most cited findings.
Estimated split of one SOP revision, 12 working days by hand; the 2-day total with the solution is its target.
Five specialist agents read, match, draft and check every change; quality approves and signs.
Veltara Therapeutics' quality council has adopted the draft revision of EU GMP Annex 11 early, effective at its Aldenbrook sterile fill-finish site on 3 November 2026. Here is what happens next, screen by screen, in the working solution.
Ruth opens the regulation ripple. The Annex 11 revision — draft text of 7 Jul 2025, adopted early by the quality council on 5 Oct 2026 — is already split into clauses. 214 SOPs answer to Annex 11, one square each, grouped by department: 61 need a change, 153 are already compliant, and 104 changes are drafted.
“Choose a clause or a site change: every SOP and step that answers to it lights up, with the change already drafted.”
She selects §12.8, “Review before batch release”. The regulation reader states the requirement in plain words, the impact finder reads 214 SOPs and 4,812 steps, and the SOP drafter writes each change in template v6. Seventeen SOPs and 23 steps light up across Quality Assurance, the QC laboratories, Production, Engineering, IT and the warehouse — each with its old and new wording side by side.
Impact finder: “Read 214 SOPs, 4,812 steps, by meaning — not keywords.”
Version 7 of “Audit trail review of GMP computerised systems” said to review the chromatography data system's audit trails annually, as part of the periodic review. Draft v8 says: “Review the audit trail entries relevant to each batch before QA batch release, and record the review on the release checklist (Form QA-012-F3).” The source sits beside the step — Annex 11 rev. §12.8 — and a panel beside the draft explains why the drafter changed it.
“The clause asks for it before each batch is released, so the review moves into the release path and onto the release checklist that SOP-QA-012 already uses.”
The draft also carries what Aldenbrook changed itself. Step 5.2 comes from change control CC-2026-114: the chromatography data system moves from v4.2 to v5.1 on 3 Nov 2026, and review moves to the new “Batch events” view. Step 7.3 comes from DEV-2026-0931, where the audit trail review for batch VLT-26-0388 on Line 2 was done 9 days after QA release: an unexplained change is now raised as a deviation within 1 working day.
Sixteen of the 17 steps name their source. Step 6.7, “Allow 2 working days for the review”, has none, and is marked “No source · your call”. She can keep it with a reason, recorded in the audit trail, or delete it. Under the new clause the review blocks release, so a fixed allowance may delay batches. She deletes it.
“Step 6.7 deleted · no step left without a source.”
She runs the template check. The checker reads draft v8 against template v6 — 7 sections, 17 steps — tests the writing rules (one action per step, each step names who does it, forms referenced by number, defined terms used as defined) and cross-checks SOP-QA-012 v11, SOP-IT-418 v8 and SOP-QA-030 v14 for conflicts. Every check passes.
The template and style checker reports; it never rewrites and never approves.
Back on the ripple she sends the §12.8 batch. Each draft goes to its process owner, then to the Head of Quality: 4 through Ruth, 5 through Kwame Asante for the QC laboratories, 4 through Hannah Reyes for Production, and 4 through the engineering, IT and warehouse owners. The training list goes with them: 146 people, 211 assignments, due before the effective date.
“Nothing becomes effective until signed.”
The approvals screen now holds 20 drafts: the 17 for §12.8, each with its changes, source and approver, and 3 others. Every draft can be read before it is approved. Median time from draft to signature over the last 90 days: 2.1 days.
Tomas approves the batch. The signature carries its meaning — “Approved — content is correct, complete and traceable to its sources” — with his password and a second factor on his registered device. The 17 SOPs become effective on 3 Nov 2026, after training.
The training-need writer compared old and new steps for the 17 SOPs: 38 tasks change, 173 only the wording. QA reviewers, the QA release team, chromatography reviewers and Qualified Persons get classroom sessions due 27 Oct; reading is due by 30 Oct. The 211 assignments are released to the learning system the moment each SOP is signed.
“Assignments are released when each SOP is signed.”
The same Annex 11 change, seen by the four people who carry it — what it looked like before, and what it looks like now.
Five specialist agents read, match, draft and check every change; quality approves and signs.
Reads a new or revised regulation or guideline and splits it into numbered clauses, each with its requirement in plain words and its status: draft, final or in force.
Matches each clause or site change to the SOP steps that implement it, contradict it or should implement it — by meaning rather than keywords — and gives the reason for each match.
Rewrites only the matched steps in the site template — one action per step, the actor named, forms by number — with the source of every step beside it and a redline against the effective version.
Checks each draft against the site template and its 14 writing rules, cross-checks every SOP the draft references for conflicts, and lists each failure with its step number.
Compares old and new steps to decide whether the task changes (classroom) or only the wording (read and understand), finds the people trained on the SOP and drafts assignments due before the effective date.
Review every change, approve and sign. The agents propose; a named person decides.
Ask in plain words about an SOP, a clause, a change or who must retrain. Every answer points to the screen it came from.
Which SOPs does the new audit trail clause touch?
17 SOPs, 23 steps. Annex 11 rev. §12.8 asks for the audit trail review before batch release. Today 7 of them put the review in a cycle, from weekly to yearly; the other 10 do not ask for it before release. The biggest change is SOP-QA-044 step 6.3.
Why does step 6.3 of SOP-QA-044 change?
Version 7 puts the chromatography audit trail review in the yearly periodic review of the system. The revised clause asks for it before each batch is released, and DEV-2026-0931 shows the gap: batch VLT-26-0388 was reviewed 9 days after release. The draft moves the review onto the release checklist, Form QA-012-F3.
Which SOPs have steps with no source?
0.6% of steps across the library have no regulation, site record or SOP behind them, down from 3.1% in January. One is SOP-QA-044 step 6.7, “Allow 2 working days for the review”. The library can be filtered to them.
Who has to retrain before 3 November?
146 people, 211 assignments. 38 are classroom sessions because the task itself changes: QA reviewers and Qualified Persons now review audit trails before release. The other 173 are read-and-understand. Assignments are held until each SOP is signed.
13 screens from the working solution, on its sample data. Pick one to see it large.
How SOPs are drafted, checked and approved at the site is a setting, saved and on the audit trail.
| Setting | Default | Choose from |
|---|---|---|
| SOP template | Veltara SOP template v6 · 7 sections | The site's own SOP template |
| Writing rules | 14 on | One action per step · each step names who does it · forms referenced by number · imperative voice · defined terms used as defined · steps under 40 words · and more, each on or off |
| Every step needs a source | Block approval | Block approval · Warn only |
| Approvers | Process owner → Dr. Tomas Lindqvist | Set per department: Quality Assurance, QC laboratories, Production, and Engineering, IT, Warehouse, Validation |
| Training lead time before effective date | 21 days | Set in days |
| Periodic review interval | 36 months | Set in months; 24 months for computerised-system SOPs |
| Source priority | Regulation in force, or a draft adopted by the quality council → approved site change control → closed deviation or CAPA → another effective SOP → template | When two sources disagree, the drafter follows the higher one and shows both to the reviewer |
| Sources the agents read | EU GMP Guide incl. Annexes 11, 15, 22 · 21 CFR Parts 11, 210, 211 · ICH Q9(R1), Q10 · PIC/S PI 041-1 · change controls, deviations, CAPAs | Each on or off, including corporate quality standards |
Every figure is labelled: a target the solution is built to, an estimate, a typical published result, or a proven one.
“demo” = seen in the working solution, on its sample site data · “target” = the design goal, measured in the live solution · “estimated” = our estimate, including the 11-week and 12-day baselines · “typical” = published figures (21 CFR 211.100 among the three most cited sections at US sterile drug sites in 2024, from a published analysis of FDA observations). Regulatory context: European Commission consultation drafts of a revised EU GMP Annex 11 and Chapter 4 and a new Annex 22, 7 Jul 2025; clause wording on the screens follows the draft text. People, the company, the site, SOPs, records and batches named on this page are fictional — characters and sample data in the working solution.
Software that drafts and updates the standard operating procedures a GMP site runs on, from the regulations and site changes they answer to. GxP SOP Authoring adds five agents that read a new clause, find every SOP step it touches, draft the revised steps in your template with a source beside each one and list who must retrain — for quality to review, approve and sign.
The regulation reader splits the new text into clauses with their requirement in plain words. The impact finder then reads every step of every SOP in scope and matches each clause to the steps that implement it, contradict it or should implement it — by meaning, not keywords — with the reason for each match. In the working solution, 214 SOPs were checked against the Annex 11 revision in 3 days.
Yes. Matching is by meaning, so a step like “Review alarm acknowledgements quarterly” in a building management SOP is found for the clause on audit trail review before batch release, even though it never says “audit trail”.
Yes. Change controls, deviations and CAPAs are sources like any regulation. In the working solution a chromatography data system upgrade and a deviation found at self-inspection each drafted their own steps into the same SOP, with the record number beside each step.
It is kept and marked “No source · your call”. The SOP owner deletes it or keeps it with a reason, which is recorded in the audit trail; by default an unsourced step blocks approval, and that rule is a setting.
No. The agents have read-only access to effective SOPs and GMP records. Every change is a draft with a redline against the effective version, and nothing becomes effective until it is approved and signed under document control.
Yes. The QA document owner accepts, edits or rejects every change; the process owner and the Head of Quality approve and sign, with the meaning of the signature recorded. The agents never approve, and training assignments are released only when each SOP is signed.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your SOP template and writing rules, your SOP library and the regulations you answer to — and it goes live once every quality gate has passed. We will walk you through it on your own SOPs first.
Any batch-record question answered in seconds, cited to the page and step.
1-min demoValidation Document AutomationProtocols drafted in minutes, every value traced to its source.
1-min demoManufacturing Batch AnalyticsBatch analysis that took three months now takes hours, with the query behind every answer.
1-min demoWe'll run GxP SOP Authoring on a sample of your own SOPs against a regulation change you are working on.