AI for Generic Drug Manufacturers
Put your history to work in every quality investigation.

Give quality teams a usable memory of previous investigations, with evidence, actions and approvals connected from the start.

Talk to UsExplore Your Challenges
BUILT AROUND YOUR WORK

The next investigation should learn from the last.

When quality teams work through repeated investigations, searching for history can consume the time needed to understand the problem.

Generic ManufacturersIllustrative workflow · explore a challenge
WHERE THE WORK GETS STUCK

A familiar deviation returns, but the earlier cause, action and effectiveness check are difficult to find together.

Current deviation
Historical CAPA & effectiveness checks
WHAT YOUR TEAM GETSFor human review

A recurrence review packet

  • Related cases surfaced
  • Previous actions visible
  • Effectiveness evidence linked
DECISION OWNERCAPA owner
HOW WE HELP

Retrieve comparable cases and their outcomes inside the CAPA workflow, so investigators can assess recurrence with the evidence in view.

Explore the relevant workflowsCAPARisk Assessment
Validation approachGAMP 5

Validation runs alongside the build — specification, qualification, traceability, reporting.

Explore the foundation
WHAT WE BRING TO THE TABLE

Generic pharmaceutical quality software, where it matters most.

We scope the combination around your process and data. Each workflow below has its current development status shown.

01Most developed workflow
Quality & Manufacturing

CAPA

Investigations that hold up.

Coaches your investigators with comparable cases and root-cause checks. Only your people can approve or sign.

Explore CAPA
02Supported workflow
Quality & Manufacturing

OOS / OOT

Every result, in context.

Comparable results, lab-error evidence and trend context — in front of the person who concludes.

Explore OOS / OOT
03Supported workflow
Quality & Manufacturing

Change Control

Know what a change triggers.

See comparable past changes and the validation work this one may trigger. A named person decides.

Explore Change Control
More workflows for Generic Manufacturers3 more
THE OUTCOME TO DESIGN FOR
  • Comparable history in every quality investigation
  • Recommendations linked to their source records
  • Human approval enforced and recorded
A PRACTICAL FIRST CONVERSATION

Start with a recurring investigation your team already knows well.

You do not need a finished specification. Start with the work you want to improve.

01 / YOUR CONTEXT

What helps us understand the problem

  • A recurring quality problem
  • A small set of completed investigations
  • Your current review and sign-off procedure
02 / OUR DISCUSSION

What we’ll work through together

  • What history would help the investigator
  • How to fit the existing quality process
  • What validation and adoption would involve
Bring the people closest to the work
Head of IT or Digital TransformationHead of QualityQuality leadership

Put your quality history to work.

Show us where an investigation gets stuck. We’ll identify the records, workflow and controls needed to make that step more useful.

Bring your challenge.
Let’s find the right next step.

Talk Through Your Challenge
Looking at a different type of organisation?
Pharmaceutical ManufacturersCDMOsBiotech & DiscoveryResearch Teams

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