Cited answers from your master batch records, down to the page and step
Any batch-record question answered in seconds, cited to the exact page and step.
See one case, screen by screen ↓“What is the hold time after viral inactivation at Plant 3, and how does it differ from Plant 1?” The answer sits on one step of a 412-page purification record written in Dutch, and on one step of a 386-page English record at another site. Then it has to be checked against the criticality analysis and the registered range in Module 3.2.S.2.2 — and against the right version of each, because records are revised under change control.
Quality and MSAT scientists do this by hand, across hundreds of pages of batch records, criticality analyses and filings that are multilingual, versioned and plant-specific. It is slow, and a missed detail — an upper limit 0.5 mS/cm above the filed range, a hold clock that starts at a different moment — can contribute to a failed batch.
Estimated split for one plant-vs-plant comparison prepared for a change control, by hand and with the solution.
Five specialist agents find, translate, compare and check every answer; a quality reviewer verifies it at the cited step.
Dr. Maya Chen, quality reviewer for all sites, needs the low-pH viral inactivation hold at Plant 3 — Leiden and how it differs from Plant 1 — Westbrook. Here is what happens next, screen by screen, in the working solution.
Maya opens the solution: 86 answers this week across 4 plants and 3 languages, 3 waiting for her check, one of them different from the filing. Below, the document changes — Plant 3 batch record v5.2 is effective, with 3 ultrafiltration steps changed since v5.1.
Needs you: “AEX load conductivity at Plant 3 vs filing — Plant 3 range is 0.5 mS/cm above the filing · Regulatory CMC notified.”
She types the question as she would ask a colleague. The Batch Record Agent scopes the search to Veltrimab drug substance at Plants 1, 3 and 5, searches 1,946 documents and finds 38 passages about low-pH viral inactivation. It reads the Plant 3 record in Dutch (v5.2, page 212, step 7.4.3) and the Plant 1 record (v7.0, page 198, step 9.6.2), while the sources fill in on the right.
“Answered in 4.8 s” — every step shown as it runs.
Plant 3 holds 60 to 90 minutes at 18–25 °C, timed from when the eluate reaches pH ≤ 3.70 and the mixer is stopped. Plant 1 holds 45 to 75 minutes at 15–25 °C, from when acid addition is complete. Both sit inside the filed 45–90 minutes. Four citations, 0.96 confidence — and the source step shown in its own language, with the Language Agent’s English translation beside it.
Language Agent: “numbers and units unchanged.”
The same step lined up across both plants, every cell cited to its page and step. Hold time, clock start, temperature and neutralization differ — Plant 3 must neutralize to pH 5.0–5.5 within 30 minutes, Plant 1 within 60. Target pH, criticality and the filed range are the same.
Both ranges sit inside the filed range. The cited versions are the effective ones — v5.2 at Plant 3, v7.0 at Plant 1. Hold time is a critical process parameter at both plants. And one warning, about the clock.
“The clock starts at a different moment at each plant — worth aligning in the next revision.”
One click opens the master batch record at page 212 of 412, step 7.4.3 highlighted in the Dutch original — “Houdtijd: start de timer zodra pH ≤ 3,70 is bereikt” — with the English translation of the whole page alongside, and the step’s record and initials columns intact.
Maya verifies the answer: 4 citations, the comparison table, 4 checks. She picks the meaning of the signature — verified against the source documents, or fit for use in a deviation investigation or a change control — and where it will be used, such as change control CC-2026-0812 to align the viral inactivation hold.
“Your electronic signature, its meaning and the cited versions are kept in the audit trail.”
The answer turns Verified. Its history shows every step — Maya asked, the Batch Record Agent answered with 4 citations, the Process Comparison Agent built the table, the Criticality & Filing Check Agent ran the checks, and Maya signed it as a verified answer for the team.
Lena’s question about AEX load conductivity came back different. Plant 3 runs the load at 5.0–8.5 mS/cm (page 188, step 8.2.3); the filing registers 5.0–8.0 and Plant 1 matches it. The row is marked “Outside filing”, and Dana Okafor in Regulatory CMC has already been notified.
A difference from the filing always goes to a person.
Accuracy is scored every week on 120 expert answers written by MSAT and Quality — 0.95, up from 0.88 on the earlier pipeline. 431 questions in 30 days, 14 minutes to a checked answer against 42 by hand, and low-pH viral inactivation the most asked step, with 112 questions.
Quality, MSAT and Regulatory CMC across four plants — what answering a question looked like, and what it looks like now.
Five specialist agents find, translate, compare and check every answer; a quality reviewer verifies it at the cited step.
Answers manufacturing questions over raw batch records, criticality analyses and filings — always with document, version, page and step. Quotes the step in its original language with the English beside it, and shows both sources when two disagree.
Translates Dutch and French batch-record steps into English, keeping numbers, ranges, units, equipment tags and step numbers exactly as written — decimal commas become points only in the English text — and keeps the original beside the translation.
Lines up the same process step across two plants or two versions — matched by meaning, not by step number — and marks a row as different only when the values differ after unit and decimal normalization.
Finds each parameter’s classification in the effective criticality analysis and its registered range in Module 3.2.S.2.2 and 3.2.S.2.4, and flags any batch-record range outside the registered range, saying by how much.
Labels each new document by plant, product, version, language and process step, maps every step number to its page, and retires superseded versions — reading in place, with no migration.
Verifies every answer at its source. The agents propose; a named person decides.
Ask about any batch record, plant or version — or tell it what to change. Every answer cites the page and step.
Which answers still need my check?
Three answers are waiting for you. AEX load conductivity at Plant 3 sits 0.5 mS/cm above the filed range; Protein A resin cycles and the neutralized pool hold at Plant 5 need a signed check before use. I have filtered the question list for you.
Compare Plant 3 and Plant 5 for viral inactivation
Lining up step 7.4.3 at Plant 3 with step 7.3.4 at Plant 5. They start the clock the same way, but Plant 5 holds 50–80 minutes at 16–24 °C. The table is open on Compare.
What changed between Plant 3 batch record v5.1 and v5.2?
Three ultrafiltration steps changed under change control CC-2026-0741: the TMP target narrowed to 0.8–1.2 bar, diafiltration rose from 7 to 8 diavolumes, and a new 4-hour limit applies to the over-concentrated pool.
Add a rule: flag any batch record range outside the filed range
Done. Every answer now checks the batch record range against the registered range in Module 3.2.S.2.2 and 3.2.S.2.4, and flags a difference in red. The rule is on in Settings, and it is recorded in the audit trail.
13 screens from the working solution, on its sample data. Pick one to see it large.
Languages, versions, checks, signers and site access are settings, not a project.
| Setting | Default | Choose from |
|---|---|---|
| Answer language | English + original language | English + original language · Original language only · English only |
| Cite document, page and step | Always on | Required for every claim — cannot be turned off |
| Only cite effective versions | On | Superseded versions only when a question names them |
| Say “not found” instead of guessing | On | When no document answers the question |
| Notify Regulatory CMC on a filing difference | On | Dana Okafor is notified when a range sits outside the filed range |
| Answers used in a deviation or change control need a signed check by | Dr. Maya Chen | Dr. Maya Chen · Omar Haddad · Lena Ortiz |
| Answers about a critical process parameter need a check by | Site MSAT lead | Site MSAT lead · Dr. Maya Chen |
| Access by site | MSAT + Quality, per plant | Per-plant team · All sites |
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 plant data · “target” = the design goal, measured in the live solution (time to a checked answer) · “estimated” = our estimate. People, plants and products named on this page are characters and sample data in the working solution.
A way to ask master and executed batch records, criticality analyses and regulatory filings a question in plain words, and get the answer cited to the document, version, page and step. Batch Record Assistant adds agents that find the step, translate it, compare it across plants or versions and check it against the filing, and a quality reviewer verifies the answer.
Yes. The Language Agent translates Dutch and French steps into English, keeping numbers, ranges, units, equipment tags and step numbers exactly as written; decimal commas become points only in the English text. The original step is always shown beside the translation.
The Process Comparison Agent matches the same step by meaning, not by step number, extracts each parameter with its range, unit and criticality, and marks a row as different only when the values really differ. Every cell is cited to its page and step, and comparisons can be saved for the team.
Yes. Each parameter is checked against its classification in the effective criticality analysis and its registered range in Module 3.2.S.2.2 and 3.2.S.2.4. A range outside the filing is flagged with the size of the gap, and Regulatory CMC is notified.
No. Documents are read where they live in your quality document system — nothing is copied or migrated. The agents have read-only access, and when a new version arrives its owner confirms the effective date before the old one is retired.
It says so. “Say not found instead of guessing” is a setting, and the Batch Record Agent never rounds, converts or merges a process range.
Yes. Answers used in a deviation or change control need a named person’s signed check, with the meaning of the signature recorded. Any reviewer can flag a problem — a wrong step, a translation that changes the meaning, a newer version — and the answer goes back to review with the MSAT lead.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your batch records, criticality analyses, filings and a set of questions with expert answers — and it goes live once every quality gate has passed. We will walk you through it on your own records first.
Validation 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 filmDeviation & CAPAEvery deviation reaches a ranked, evidence-backed root cause in days, closed inside the 30-day target.
1-min filmWe’ll run Batch Record Assistant on a sample of your own batch records and the questions your MSAT and Quality teams ask.