Customers

Quality teams running better with Katalyze AI

Pharmaceutical and biotech manufacturers across solid dose, injectable, and biological product categories. Here is what they are seeing.

4.2h

avg batch review cycle

72%

reduction in deviation-to-CAPA time

100%

audit trail coverage across all records

Based on outcomes reported by early-access pilot sites. Individual results vary by batch volume and workflow complexity.

Customer results

Real-world outcomes across manufacturer types

Solid dose manufacturer

Mid-size specialty pharma, Northeast US

Challenge

Processing 200+ batches per month across two product lines. Batch record review was consuming 40% of the QA team's capacity, and exception classification inconsistency was generating re-review cycles that added 1-2 days to the average review timeline.

Result after 90 days

Batch record review cycle time dropped from an average of 3.1 days to 4.2 hours. QA team reallocated 35% of previously review-occupied time to investigation and CAPA work. Zero exception inconsistency disputes in the period following deployment.

Injectable sterile manufacturer

Contract manufacturer, Southeast US

Challenge

As a CMO operating under multiple clients' SOPs, inconsistency in deviation intake classification was creating problems in both client audit responses and their own FDA preparation. CAPA timelines were running 20-30% over SLA targets.

Result after 90 days

Deviation classification consistency improved significantly, with AI-assisted intake bringing structured fields into every intake form regardless of who filed the report. CAPA SLA compliance reached 100% in the three months following full deployment.

Biologics manufacturer

Clinical-stage biotech, Cambridge MA

Challenge

Preparing for first commercial manufacturing validation while scaling the QA team from 3 to 12. The team needed a validated QMS platform that could grow with them without requiring an ERP replacement or extended validation engagement.

Result

Completed validation of Katalyze AI in under 6 weeks using the provided IQ/OQ/PQ documentation. The quality team went from paper-and-spreadsheet to fully electronic QMS before their first commercial validation batch, with zero re-validation required during their FDA pre-approval inspection preparation.

Testimonials

What quality professionals say

"The batch record review time reduction alone paid for the annual contract inside the first quarter. But what actually changed the team's day-to-day was getting exception classification off their desks. They do the judgment calls now, not the page turning."

VP Quality Assurance

Solid dose specialty pharma, 200-batch/month operation

"We are a CMO, so we operate under 8 different client SOPs. Before Katalyze AI, deviation intake was a free-text exercise that every client interpreted differently at audit. The structured AI intake standardized what we actually capture, even when the reporter is new or the product is complex."

Director of Quality Systems

Sterile injectables CMO

"We were preparing for first commercial manufacturing while building the quality team simultaneously. Having the validation documentation already prepared meant we focused on learning the system, not writing qualification protocols from scratch. That was a real advantage for a team our size."

Head of Quality

Clinical-stage biologics manufacturer

See for yourself

Find out what Katalyze AI looks like for your operation

Bring your batch record format and deviation history to a discovery call. We will show you a working demo configured to your product type and volume.

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