Change impact assessment that finds everything a change touches, before the board meets
Every change request checked against everything it touches, before the board meets.
See one case, screen by screen ↓A change owner raises a change request and writes down the impact they know about: two SOPs to revise, and “regulatory impact: to be checked by Regulatory”. Everything else — the incoming inspection procedure, the MES recipe that only accepts one barcode format, the LIMS reference spectrum, the OQ that was run with the current bag, the registration that names the supplier in 3.2.S.2.3 — has to be found by hand, one function at a time.
So the assessment goes round the houses: Validation checks the systems, QC the specifications, Regulatory CMC works out the filing per country, and the change misses one board or comes back for information. Whatever is found late is found during implementation, when it holds up the first batch.
Estimated split for a typical major change, by hand and with the solution, in working days.
Six specialist agents read the change, search everything it touches in parallel and write a cited impact matrix; the change board decides and signs.
Plant 3 in Leiden needs a second source for its 2,000 L single-use bioreactor bags after the current supplier announced a 40 % allocation cut for 2027. Here is what happens to change CC-26-1184, screen by screen, in the working solution.
Thursday’s change control board meets at 10:00 with five changes on the agenda. Three of the five already have a complete, cited impact assessment and the agenda pack goes out at 16:00. One is new from the QMS and not assessed yet: CC-26-1184, qualifying Tessmer Single-Use as a second 2,000 L bag supplier for Veltrimab and Corventa drug substance.
“The request lists 2 SOPs. Six agents will search SOPs, systems, equipment, specifications, registrations and prior changes for everything else it touches.”
Omar’s request is a Major supplier/material change at Plant 3 — Leiden. Its known impact is one line: “SOP-USP-031 and SOP-USP-044 to be revised. Regulatory impact: to be checked by Regulatory.” The agents start from exactly that record, with the owner’s passage highlighted beside the workspace.
The Change Reader turns the request into a scope: what changes, where, and for which products and materials. Then four agents search at once — the Document Finder across 2,412 SOPs and forms, the System & Equipment Matcher across 318 systems and 604 assets, the Spec, Product & Stability Checker across 1,904 specifications, and the Registration Checker across 412 dossiers in 38 markets.
Items appear area by area as they are found, each with its disposition and confidence.
The impact matrix lists 22 touched items across nine areas: SOPs and documents, computerised systems, equipment and qualification, specifications, products, market filings, stability, suppliers and training. Three more are checked and marked not affected, with the reason. A precedent turns up at another site: CC-25-0732, the second 500 L bag supplier at Plant 5 — Cork.
“12,480 sources searched · 33 passages cited · 1 precedent found.”
SOP-WH-012, incoming inspection of single-use assemblies, was not in the request. Its Table 2 lists only the current supplier’s certificate checks and label format, and deliveries from any other supplier go on hold. Next to it, the Cork precedent: the incoming-inspection SOP and the MES barcode rule were found late there and delayed the first batch by 9 days.
Accept, mark not affected, or change the disposition — the agents propose, a person decides.
Anything under the confidence line is marked “needs your call” and is never accepted in bulk. The TF-90 film extractables data sit at 62 %: the supplier’s study covers 40 °C for 21 days, but harvest is held in the bag for up to 30 days at 2–8 °C. The MES recipe’s regression scope (78 %) goes to Validation and the Japan filing type (71 %) to Regulatory CMC.
“Accept all at 85 % or more” takes the rest in one click: 22 items accepted, 3 still need your call.
The Registration Checker reads each registration and the country rule books. For Veltrimab: CBE-30 in the US, Type IB in the EU, UK and Switzerland, prior approval in Brazil, and Japan left as her call. Corventa needs no filing in the US or EU, because its approved lifecycle document (ICH Q12) says the bag supplier is not an established condition.
“Release gate: no Tessmer-bag Veltrimab lot ships to the US until 30 days after FDA receives the CBE-30, or to Brazil before approval.”
Omar agrees. Lena agrees with a condition: no Tessmer-bag Veltrimab lot ships to the US before 30 days after the CBE-30 is received, or to the EU, UK or Switzerland before the Type IB is acknowledged. Sam Patel, Validation lead, agrees to a risk-based MES test of the bag-lot step plus the batch record print. Priya agrees on condition that extractables coverage of the 30-day harvest hold is confirmed before the first GMP batch. Jonas Becker votes in the meeting.
Dana signs with her password and the meaning “Approved as change board chair”. The decision is approval with three conditions, and the three open calls are carried as conditions — each goes to its owner, to decide before the first GMP batch.
Accepted items become 14 tasks with owners and dates, set from 214 similar tasks at Plant 3 since 2024, and are pushed to the QMS with 56 training assignments. Eleven tasks gate the first batch — documents, systems, the OQ addendum for BR-301/302, supplier audit and quality agreement, extractables and training. First batch on Tessmer bags: Nov 20, six weeks from approval.
Shown beside it: 8–10 weeks, typically reported in the industry without agents.
The same change, seen by the five people who carry it — what their week looked like, and what it looks like now.
Six specialist agents read the change, search everything it touches in parallel and write a cited impact matrix; the change board decides and signs.
Reads the change request and turns it into what changes, where, for which products and materials — the scope the other agents search with.
Searches SOPs, work instructions, forms and master batch records for every document the change makes wrong, and who is trained on each.
Matches the change to validated computerised systems (ERP, MES, LIMS) and qualified equipment, with a proposed assurance level.
Checks specifications, methods, products and stability commitments — including the ones that are not affected, with the reason.
Reads each registration and the country rule books and drafts the filing category per product and market, through an ICH Q12 lens.
Writes the cited impact assessment for the board, and after approval turns accepted items into an implementation plan with a release gate.
Votes and signs, with conditions. The agents propose; a named person decides.
Anyone on the board can ask what a change touches, where it needs a filing or who is waiting on whom — or tell it what to change. Answers cite their sources.
What does CC-26-1184 touch that the request missed?
It touches 22 items in 9 areas; the request listed 2. The ones most likely to stop the first batch: SOP-WH-012 incoming inspection accepts one supplier only, MES step 4.2 rejects the new label format, the LIMS FTIR reference covers the old film only, and the BR-301/302 OQ was run with the current bag only. The same two gaps delayed the Cork precedent by 9 days.
Which markets need a filing for CC-26-1184?
Draft filing plan, for Lena Ortiz to confirm. Veltrimab: notify and wait in the US (CBE-30), EU, UK and Switzerland (Type IB), Canada and Singapore; prior approval in Brazil; implement, then tell in Australia, China and Korea; Japan is your call. Corventa: no filing in the US or EU — not an established condition. No Tessmer-bag Veltrimab lot ships to the US until 30 days after the CBE-30 is received.
Is the E&L data enough?
Probably, but it is QC’s call. The supplier’s study covers 40 °C for 21 days; the culture runs 16 days at 36.5 °C, so that is covered. The harvest can sit in the bag for up to 30 days at 2–8 °C — colder, but longer than 21 days. SOP-QC-207 asks for worst-case conditions. Confidence 62 %, so it is in Priya Raman’s queue as a condition before the first GMP batch.
Add a rule: flag any change that touches an established condition
Done — I added a rule for your approval: “Flag any change that touches an established condition, and list the products whose lifecycle document names it.” It is now in Settings → Rules, switched on for Plant 3.
13 screens from the working solution, on its sample data. Pick one to see it large.
How the agents assess changes and how the board decides are settings.
| Setting | Default | Choose from |
|---|---|---|
| Send to a person below this confidence | 85 % | 75 · 85 · 90 % |
| Filing categories are drafts | On — Regulatory CMC confirms | Required by the quality policy — cannot be switched off |
| Look for precedents at every site | On | Searches 6,830 prior changes |
| Assess new changes as soon as they arrive | On | Or the owner starts the assessment |
| Board meets | Thursdays · 10:00 | Agenda pack goes out the afternoon before |
| Major changes need | QA · Regulatory CMC · Validation | Add QC |
| Minor changes | QA alone | Who can approve without the board |
| A change to a product-contact material | Always opens an extractables and leachables item | A rule added by Priya Raman · Aug 2026 |
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 data · “target” = the design goal, measured in the live solution · “estimated” = our estimate · “typical” = published figures (BioProcess International, AI in biopharmaceutical quality management — 8–10 week change cycles). ICH Q10, ICH Q12 and EU GMP Annex 15 are named as context. People, companies and products named on this page are fictional — characters and sample data in the working solution.
It is the record of everything a proposed GMP change touches — procedures, validated systems, equipment, specifications, products, stability, suppliers, training and market registrations — and what has to happen to each before the change can be used. The Change Control Impact Assessor drafts it with six agents, cites every item to its source and puts it in front of the change board.
The Change Reader extracts the changed item, sites and products from the request; then four agents search the document library, validation inventory, specifications and registrations in parallel. By default a document counts as touched when it names the changed item, its part number or its supplier. Items not affected are listed too, with the evidence.
No — it drafts it. The Registration Checker reads each registration and the country rule books, checks whether the change touches an established condition under ICH Q12, and proposes a category per product and market. Regulatory CMC confirms every one, and anything it is unsure about is marked as their call.
No. The agents search read-only copies synced from your systems of record and never write to them without a person. Tasks are pushed to the QMS only after the board has signed.
Yes. Items under the confidence line go to a named person and are never accepted in bulk. Major changes need QA, Regulatory CMC and Validation votes before the chair signs, and each decision is signed with a password and its meaning.
The Impact Writer & Planner turns accepted items into tasks with owners and dates, carries the board’s conditions as a release gate and shipping restrictions, and pushes the actions and training assignments to your QMS and training system. No changed batch is released until every gating task is done.
Your QMS, document library, registration system (RIM), validation inventory, ERP and training system. It searches what each change needs and records the passage behind every item.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your change control SOP, board rules, registrations and a sample of past changes — and it goes live once every quality gate has passed. We will walk you through it on your own change controls first.
Any batch-record question answered in seconds, cited to the exact page and step.
1-min filmValidation DocumentsValidation protocols and reports drafted in minutes, every value traced to its source page.
1-min filmAsk the PlantBatch analysis that took three months now takes hours, with the query behind every answer.
1-min filmWe’ll run the Change Control Impact Assessor on a sample of your own past change requests.