AI for compliance work
AI document review holds up in an audit when the model only reads, checks and drafts, a named person reviews and approves every record, and calculations and signatures run in ordinary validated code. Evata Consulting Group, led by Jared Clark, builds systems on those rules for compliance and quality teams, including document control and batch record drafting at an FDA-regulated dietary supplement manufacturer. Your reviewers stop reading everything by hand and spend their time on the exceptions the system flags.
What an auditor will ask
An auditor looks at your process and your records. These are the questions we build the system to answer.
Your own reviewers and approvers sign. The model never does.
The system is tested and documented for its intended use, with the depth of testing scaled to the risk of each function.
An audit trail shows what the system drafted, what a person changed, and who approved it.
Document control tracks versions and approvals, and it checks cross-references across the set.
Yes, so the process assumes it. Review steps and exception flags are part of the design, and you keep the evidence that they ran.
Systems holding regulated records run in your own environment, and customer data is not used to train any model.
Three kinds of work
The same rules carry across contracts, records and quality documents.
Check documents against your criteria and flag what is missing or does not match, so review takes less of your team's time. We have not yet shipped a contract-review system, and we will say so in the assessment.
Extract specifications from source files and draft master manufacturing records for a person to review. For FDA-regulated companies, we scope this against the rules that apply to you, such as 21 CFR Part 11 and Part 111.
Draft SOPs from your source documents and templates. Drafts go to a person for review and approval before they become controlled documents.
What we have built
We describe them without naming the customers. More detail is on our AI for document review page.
Customer purchase orders arrived by email and were retyped into an order tracker. Now each email is read by OCR, an AI model turns it into a structured order, and the workflow writes it to the tracker.
An on-premise system for document control with electronic signatures, inventory, training and batch records. AI extracts specifications from source files and drafts master manufacturing records for a person to review. Approvals, signatures and batch calculations are ordinary validated code, with no AI in them.
Who builds it
Evata is led by Jared Clark, JD, MBA, PMP. He has spent twelve years leading quality and FDA regulatory programs, and he holds computer system validation and computer software assurance certifications, which cover how software is tested and documented for FDA-regulated use. Evata Consulting Group is based in Salt Lake City, Utah. We build on Claude and on OpenAI's models.
Common questions
Look for a builder who has worked under audit. Evata Consulting Group builds these systems with a person's approval on every record, an audit trail of who did what, and validated code for anything that must be exactly right. Our founder, Jared Clark, spent twelve years in quality and FDA regulatory work.
The risk comes from letting a model make decisions or change records without control. We built an on-premise platform for a dietary supplement manufacturer in which AI drafts and a person approves, while approvals, signatures and batch calculations are deterministic code. You stay responsible for your quality system, so your quality unit decides how the system is used.
Yes. The platform we built drafts records for review and also checks the document set itself. On one pass it found 60 broken document references and 105 citations to documents that did not exist, which the quality team then corrected.
You need evidence that the system is fit for its intended use, scaled to its risk. Keeping exact work in validated code and keeping a person's review on AI drafts makes that evidence much easier to produce. FDA's computer software assurance guidance is a useful starting point for the risk-based approach.
No. They keep the decisions. The system does the first read and the first draft.
The assessment is free. You leave with your processes ranked by value and a clear picture of what a first build looks like.