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Pharma & life sciences

Prove competence, not just training records

Opigno tracks who is qualified on which SOP version, across every site and affiliate. It trains people when a procedure changes and verifies they understood it, so you're ready when the inspector asks.

Trusted by teams at

  • Bayer
  • Pfizer
  • Boehringer Ingelheim
An operator in a cleanroom suit, hairnet and mask checks tablets on a production line

Skills analytics (Top 10 by points)

Radar chart of the top 10 skills by points
#SkillPoints
1GMP Documentation Practices140
2ALCOA+ Data Integrity131
3Aseptic Technique112
4Deviation Management105
5CAPA Investigation98

Sound familiar?

  • “Every SOP revision triggers another round of read-and-sign.”

    Hundreds of people acknowledge a document, and no one knows who actually understood what changed.

  • “Our training records prove attendance. Inspectors ask about competence.”

    The record shows a signature and a date. It doesn't show that the person can perform the task as described.

  • “Each affiliate trains its own way.”

    Different systems, languages and formats make one consolidated picture a manual exercise before every audit.

  • “A launch depends on hundreds of people being ready on the same day.”

    Field teams, medical affairs and manufacturing all need different knowledge, on time, and proof that they have it.

How it works

From SOP change to verified competence

  1. Detect

    When an SOP is revised, Opigno identifies who is affected, by role, site and affiliate, and what changed for them.

  2. Teach

    Each person gets instruction on what changed in their part of the procedure, not the whole document again, in their language.

  3. Verify

    Clara checks that the change was understood and can be applied. Where needed, a qualified person validates the practical step.

  4. Measure again

    Qualification status updates per person and per SOP version, and the next revision starts the loop again.

Your QA and training teams configure the agents — which documents they use, who must validate, and where a human signs off.

What pharma teams use Opigno for

Use caseWhat changes for you
SOP trainingPeople are trained on what changed for them, with understanding verified rather than signatures collected.
Inspection readinessShow who is qualified for which task, on which SOP version, with the evidence behind each qualification.
Multi-affiliate governanceEach affiliate keeps its own rules, content and languages. Global QA sees one consolidated view.
Product launchesField, medical and manufacturing teams each get the knowledge they need, with readiness tracked before launch day.
Onboarding in GxP rolesNew hires start from what they already know and reach qualified status sooner.
Field force trainingProduct and compliance knowledge kept current for sales and medical teams, on mobile.

Fits a regulated environment

  • Your models, your data

    Personal data stays in a dedicated environment, in the region you choose or in your own data centre, with the AI models you already use.

  • One view across affiliates

    Each country keeps its own rules and languages, and global QA and HR see one picture.

  • Connected to your systems

    Opigno reads roles and org data from your HRIS and document systems, and writes verified qualifications back.

Questions we hear often

Can Opigno work with our document management system?

Opigno connects through open APIs, so SOP revisions can trigger the loop automatically.

Does the AI decide who is qualified?

No. You decide which steps need human validation and who gives it. The AI never qualifies anyone on its own.

Can each affiliate keep its own content and language?

Yes. Each affiliate has its own space, rules and languages, under one governance.

Start with one SOP.

Bring a recent SOP revision. In a working session, we'll show you who it affected, what they needed to learn and how you'd verify it.

Talk to us