Guide: what the draft Annex 22 requires of AI in GMPRead the guide

Lingua: GxP documents translated between Spanish and English without touching the format

Gutis needed a tool to translate procedures and work instructions for an inspection. The ComplAI team built Lingua.

  • Client: Gutis
  • Original format intact
  • AI translates, a person reviews

A translator that does not touch the document

Lingua translates GxP procedures and work instructions between Spanish and English while keeping the original format: styles, tables, numbering, headers and images come out identical. AI translates; fixed rules check the format, the figures and the codes; and a person resolves whatever has more than one possible translation. It is not an online Word editor or a document management system.

The need

Many documents and a format that cannot be touched in GxP.

Gutis had to deliver a set of procedures and work instructions in English for an inspection.

An ordinary machine translator would not do: a GxP document is reviewed and approved with its format, and changing a style, a table or a numbering means reviewing it again. And a mistranslated figure, code or regulatory reference is a finding.

It needed a custom tool, on three conditions:

The format, intact

The translated document has to be the same document: the same styles, tables, numbering, headers and images.

Not a single figure changed

A dose, a temperature range or a procedure code has to come out exactly as in the original.

A person decides

Whatever has more than one possible translation is decided by someone who knows the plant, and who decided it stays on record.

The solution

An application where AI translates whole batches of documents, fixed rules check the result and a person resolves the doubts.

  • The person
  • AI
  • Lingua, without AI

01 · The personUploads the documents or a whole folder and picks the target language02 · Lingua, no AIChecks what each file really is, proposes its language and flags a document that was already translated03 · AITranslates with the approved glossary and the translation memory, and flags terms that have more than one translation04 · Lingua, no AIReplaces only the text and checks that styles, tables, numbering, headers and images are unchanged; figures, codes, units and standards are compared by rules, with no AI05 · The personReviews each doubt next to the original: accepts the proposal, picks an alternative or writes their own06 · Lingua, no AIApplies the decision to every document where the term appears and saves it to the glossary07 · The personDownloads the ZIP with the same folder structure, or each document with the original and the translation together08 · Lingua, no AIRecords every action with who did it, when and in which time zone

  1. 1. UploadThe personUploads the documents or a whole folder and picks the target language
  2. Lingua, no AIChecks what each file really is, proposes its language and flags a document that was already translated
  3. 2. TranslationAITranslates with the approved glossary and the translation memory, and flags terms that have more than one translation
  4. Lingua, no AIReplaces only the text and checks that styles, tables, numbering, headers and images are unchanged; figures, codes, units and standards are compared by rules, with no AI
  5. 3. ReviewThe personReviews each doubt next to the original: accepts the proposal, picks an alternative or writes their own
  6. Lingua, no AIApplies the decision to every document where the term appears and saves it to the glossary
  7. 4. DeliveryThe personDownloads the ZIP with the same folder structure, or each document with the original and the translation together
  8. Lingua, no AIRecords every action with who did it, when and in which time zone

A document that fails the format check is not delivered. Everything stays in the audit trail: who uploaded, reviewed, corrected and downloaded each document, and when.

Only the text changes

Lingua does not rebuild the document: it replaces only the text and copies everything else as it is. Before delivering it, it checks that styles, tables, numbering, headers and images are unchanged; if not, it does not deliver it and says so.

Figures are watched by rules, not by AI

Figures, codes, units and regulatory references are compared with the original by fixed rules, deliberately without AI: it is an exact comparison, and a model could make the very mistake it is meant to catch. Whatever does not match shows up as a critical warning.

AI flags its doubts

Terms that have more than one possible translation come out flagged. The review goes from one doubt to the next, across documents too, and a decision is applied to the whole batch at once.

A glossary for the plant

Approved terms are mandatory in every translation, and Lingua proposes the ones that repeat most in the real documents. If someone uploads a document that was already translated, they are told, so it is not paid for twice and there are not two versions of it.

Original and translation, together

Besides the translated document, each one can be downloaded as a single Word file with the whole original followed by the whole translation, without changing a single byte of the original.

Benefits

What changes when AI translates, rules check and a person decides.

Built with real documents

Lingua was fine-tuned with Gutis's real documents: when one could not be translated, it was diagnosed with the file itself and fixed in production.

The format, guaranteed

A document that fails the format check is not delivered. What reaches the person is the same document, with the text in the other language.

More control, in real time

Every document has a traffic light: no issues, warnings or critical warnings, which are shown first. Whatever is ready can be downloaded without waiting for the rest of the batch.

Everything on record

Every action stays in the audit trail with the name of who did it and the time, in their time zone and in the viewer's, and it exports to CSV. Each person signs in with their own account and sets their own password.

Also

  • It translates whole batches, including folders with their subfolders, and the ZIP downloads with the same structure and the same names plus _EN or _ES.
  • A mistranslated term is found and corrected across the whole batch at once, with a button to undo it all.
  • A review version carries the doubts highlighted and commented in Word, with a name that cannot be confused with the final one.
  • PDFs are translated, but they come out marked to be reviewed in full, because their format is a reconstruction. A scanned PDF is rejected, and the reason is given.
  • Each person sees their own batches and an administrator sees all of them. A document is shared one at a time, and while someone is correcting it, nobody else can modify it.
  • Documents are stored encrypted in Germany, and what each one cost to translate stays on record even after it is deleted.
  • 1,304 automated tests passing and three rounds of independent review.

“We needed to deliver procedures and work instructions in English without touching their format. With Lingua, AI translates, we resolve the doubts and every document comes out with the same format as the original.”

Greivin Mora SAP Competence Center Manager at Gutis

Let's talk about your documents

If you have a GxP process that needs a custom tool, tell us which one and we'll tell you how we would approach it.