Pharma
Inside a validated system
For manufacturers held to 21 CFR Part 11 and GxP. The system sits inside the quality system, answers from batch records, SOPs, deviations and CAPAs, and protocols, and quality assurance reviewers check the answers.
What runs in this room.
- Exalt AtlasReads batch records, SOPs, deviations and CAPAs, and protocols where they already are, or takes them uploaded to the box inside the quality system.
- Exalt LedgerQuality assurance reviewers decide what the system may use; every correction is on the record.
- Exalt AgentsConfigured around the work, with quality assurance reviewers signing off.
- Exalt AutomationsReporting, approvals and reviews, and data entry and reconciliation, built from those agents and signed off by quality assurance reviewers.
Who it's for, and who checks.
- What the organization is held to21 CFR Part 11 · GxPThese are what the organization answers to. None of them is an Exalt certification.Certifications
- Where the system sitsThe quality systemDay to day it runs with no outside connection. Updates need a connection.
- What it answers fromBatch records, SOPs, deviations and CAPAs, protocols
- Who checks the answersQuality assurance reviewers
Put local AI to work where it matters most.
Bring two things: the material you would approve, and the person who would check the answers. That is where a consultation starts.