Pharma: open models you control, in your own cloud account.
Exalt Reserve
For manufacturers whose GxP and quality data already sits in AWS, Azure or Google Cloud. Exalt Reserve deploys open models, retrieval, agents and monitoring into that account rather than running as an Exalt-hosted service.
Where a manufacturer starts.
GxP data already in the cloud
If your GxP data already sits in your own cloud account, Reserve deploys into that account and the models run there too.
A cloud AI tool is a supplier to qualify
ISPE's guidance on SaaS for GxP use describes a supplier assessment scaled to intended use and risk, and a quality agreement that leaves GxP accountability with the regulated company.ISPE guidance on SaaS for GxP use
Electronic records have their own rule
21 CFR Part 11 sets FDA's requirements for electronic records and electronic signatures.21 CFR Part 11
Your review
Your organization runs its own review and stays responsible for its conclusions.
Same question. Different access.
Two people ask Exalt Reserve the same question. Each answer comes only from the documents that person can read.
Signed in as a quality assurance specialist
- A quality assurance specialist asks: "Who approves a change to our ingredient supplier's process?"
- The answer comes from the supplier quality agreement and cites it. The question, who asked and the source shown are recorded in the audit log.
- The citation opens the supplier quality agreement at "Changes", with the passage highlighted.
Signed in as a procurement buyer
- A procurement buyer asks the same question.
- They cannot read the supplier quality agreement, so the answer never mentions it. It comes from the supplier handbook, which says who to ask.
- The citation opens the supplier handbook at "Quality agreements", and the audit log records the question, who asked and the one source shown.
Illustrative. A demonstration workspace, not a customer session.
What sits in your account.
- Models, retrieval, agents and monitoring run inside your own AWS, Azure or Google Cloud account. This is not an Exalt-hosted shared service.
- Open models self-hosted in your account are the default: Llama, Mistral, Qwen, Gemma and DeepSeek. Which models run, and whether a use case also uses an outside AI service, is decided with you.
- Reachable only from your private network, with no public endpoint. People sign in through your own identity provider.
- Data is encrypted at rest and in transit.
- Exalt runs a management plane outside your account. It holds no customer content.
- Two bills: Exalt's software, and your own cloud bill. You keep the data, models, vector stores, credentials and subscription.
- An audit log of questions, answers and admin actions is kept in your own cloud account, and your admin sets how long history is kept.
Start with the account you already run.
Bring the cloud account, the material you would put to work and the person who reviews your vendors. The consultation starts with those three.