Katalyze for 503B Outsourcing Facilities
Keep the evidence behind each compounded batch in reach.
Every 503B facility answers to the FDA, so the evidence has to be ready before anyone asks. Katalyze connects production records, material certificates, and test results, and shows what is missing. Your quality team can see where each batch stands on any day.
- Compounding record CR-0917the production record, read into your schemaCompounding record · page 2In reviewRead · 14 fields · source kept on every value
- Certificate of analysis · the API lotCertificate of analysis · the supplierIn reviewOn file · linked to the batch
- Test report · potencyTest report · the contract laboratoryLinkedLinked · to the batch and the lot
- Review question · the API lot on this batchthe record, the certificate and the test report, in one viewInvestigation documentation · draft 1OpenOpen · evidence assembled · for the pharmacist in charge
- Batch dispositionyour quality proceduresNot decided hereWith the facility's quality procedures
5 items · 1 open question · disposition stays with the facility
Where your team's time goes.
Finding records, reconciling details, and writing up findings leave less time for the next technical question.
Explore Document Intelligence- Finding the evidence for a batch
- The hospital's order, the batch record, the quality checks, and environmental monitoring each live in a different system.
- Connecting records by hand
- Tying a batch to its materials, tests, and cleanroom conditions falls to whoever takes the initiative.
- Producing evidence on request
- When quality or the FDA asks about a batch, people stop their work to gather documents and data.
- Deciding what follows
- Your authorized experts review the reasoning and decide how to act through the facility's quality procedures.
Put the knowledge in your systems to work.
Connect the information the job needs. Your existing systems remain the source of truth.
Explore connectors- SharePointDocumentsAvailable
- Outlook / Microsoft GraphDocumentsAvailable
- SFTPFile storesAvailable
- Veeva VaultDocumentsAvailable
- SAPEnterprise systemsAvailable
Where Katalyze can support your team.
Connect the knowledge each solution needs, then use it to investigate questions and prepare work for review.
Explore all solutions- 01
Deviation Investigation
Work through a discrepancy using the relevant evidence, with missing information and uncertainty visible to the investigator.
- CR-0917 · 1 review question · open
- record · certificate · test report · linked
- Investigation documentation · draft 1
- 02
Raw Material Characterization
Examine material and supplier information in the context of the facility's process and the question under review.
- the API lot · certificate on file
- linked to the batch and the test report
- for the pharmacist in charge
Give your team time to work through the hard questions.
Katalyze investigates evidence and drafts documents. Your experts refine the work and decide what follows.
How Agentic Solutions work- Your 503B outsourcing facilities team
Your reviewers frame the question
Identify the batch, the records involved, and the people responsible for assessing the result.
CR-0917 · 1 open question - Katalyze
Katalyze reads the records
Extract and contextualize the production record, the certificate, and the test report, with the source kept on every value.
14 fields · source kept - Katalyze
Katalyze connects the evidence
Relate the batch, the material lot, and the test result so the reviewer can follow the question across them.
batch · lot · test report · linked - Katalyze
Katalyze drafts the investigation documentation
Assemble the evidence, test possible explanations, and draft investigation documentation with proposed follow-up for review.
Investigation documentation · draft 1 - Your 503B outsourcing facilities team
Your experts decide through your quality procedures
Review the reasoning and decide how to act; batch disposition stays with the facility.
pharmacist in charge · decision recorded - Katalyze
Katalyze records the work
Keep the run recorded and the context available for the next review.
run recorded · lineage kept
Katalyze in pharmaceutical operations.
The system accurately digitizes even lower-quality PDFs - impressive and reliable.
Head of AITop 5 Pharma- Faster batch release
- 40%
- Plant throughput
- Up 25%
- Increased productivity
- 30%
How Katalyze fits your team's work.
Explore the records, responsibilities, and review process behind the work.
More time for the work that moves medicine.
Bring the job you want to move forward and the records you'd like connected. Thirty minutes on how Katalyze would do the work, and where your experts come in.
Or, just a quick chat to run through the product, your call.
