Quality

For Quality teams who carry the last signature, and who have to prove why a batch was released long after the decision is made.

Back

Quality

For Quality teams who carry the last signature, and who have to prove why a batch was released long after the decision is made.

Back

The Challenge

A deviation can hold a batch for weeks, and the evidence to close it is spread across systems that were never built to agree.

Part of the answer is in the batch record, part in LIMS, part in a historian, part in a stack of PDFs. The investigation stretches, the release date moves, and the burden of proof lands on your team.

The Katalyze Approach

Agents that investigate on a source-grounded record, so every finding traces back to where it came from.

The Katalyze Agent Catalog ships agents that reason over your Primary Production Record. They investigate deviations, classify and track CAPAs, and draft APQRs, and every step carries the source it used. The agent does the assembly. Your reviewer keeps the decision.

The Results

50%

Deviation investigations, cut by half

40%

Faster batch changeover

2 days

An analysis that took a year and $1.5-3M, in one early deployment

Deployed at sites with five of the top
twenty global pharma companies

Turn confusion into clarity, today.

Book a 30-minute demo. We'll walk through a live run, deviation to release record, and map Katalyze to the systems you already have. Most teams are live in weeks.

Deployed at sites with five of the top
twenty global pharma companies

Turn confusion into clarity, today.

Book a 30-minute demo. We'll walk through a live run, deviation to release record, and map Katalyze to the systems you already have. Most teams are live in weeks.

Deployed at sites with five of the top
twenty global pharma companies

Turn confusion into clarity, today.

Book a 30-minute demo. We'll walk through a live run, deviation to release record, and map Katalyze to the systems you already have. Most teams are live in weeks.