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Pharma and Life Sciences

A qualification cycle takes quarters. The finding takes a day.

When a GMP finding lands at a Tier 2 API site, the options narrow to whatever is already qualified. Infis watches the regulatory and financial signal across your base continuously, and keeps the alternates work moving before you need it.

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What gets in the way

The four that come up every time

Problem 01

Qualification is measured in quarters

Starting the alternate search after the alert arrives means absorbing the gap rather than avoiding it. By the time a second source is qualified, the shortage has already been managed with expedite fees and allocation.

How Infis handles it

Scoring runs continuously, so the alternates conversation starts on a trend rather than an incident. Sourcing Agent keeps a ranked, pre vetted alternate set current against your approved supplier list.

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Problem 02

Quality data and spend data never meet

The QMS holds the deviations and the CAPAs. The ERP holds the spend and the open POs. Nothing reconciles them at material level, so nobody can say what a finding is actually worth in exposure.

How Infis handles it

Infis joins both, plus external regulatory action, at the material and site level. Exposure is expressed in dollars against real open POs, which is what makes the qualification budget argument.

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Problem 03

Sole source API exposure is invisible until it is not

Sites often sit in the ERP as separate vendor numbers. Concentration hides in that split, and the true single source count is higher than the system reports.

How Infis handles it

Entity resolution collapses those records to one supplier and one site, then scores concentration against it. This is usually where the surprises are.

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Problem 04

Everything has to survive an inspection

A recommendation you cannot trace back to a source record is a liability in a regulated environment, not an asset.

How Infis handles it

Every score, alert, classification, and agent action retains its source records, its reasoning, its timestamp, and the person who approved it. The log is exportable.

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Same day
from Form 483 published to category owner alerted

A Form 483 issued against a Tier 2 API site is scored and routed the day it appears in the inspection database, with the filing attached and the sole source materials behind it already joined to the alert.

Start with the supply base you already have

Send a supplier list or an open RFQ. We will run it through Infis and show you the scored result, including the exposure your current process is not surfacing.

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