Yuktav
PharmaGPT that stays inside the quality system.
Drafts with citations. People approve. Three suites: validation, QMS, documents.
PharmaGPT · grounded
Validation Suite
Proposed IQ structure
1. Scope & intended use (URS-HPLC-03)
2. Installation environment — OS, DB, networked printer
3. Configuration baseline vs. vendor spec
4. Security: unique IDs, audit trail enabled
5. Trace to SOP-VAL-014 §6.2
Sources: SOP-VAL-014, URS-HPLC-03, GAMP 5 App. D1
Three suites
Validation. QMS. Document control.
Each suite is useful on its own. Together they keep protocols, events, and SOPs from drifting apart.
Suite 01
Validation Suite
Plan, execute, and maintain computer system validation with requirement traceability, protocol authoring, executed evidence, and periodic review. Built around GAMP 5 and FDA computer software assurance.
Suite 02
QMS Suite
Assist quality events with structured root-cause analysis, similar-event search, risk scoring, and CAPA language that stays consistent with your procedures — reviewed and signed by people, never auto-closed by a model.
Suite 03
Document Control
Author, review, and retire controlled documents with impact analysis across linked SOPs, specs, batch records, and training matrices. Yuktav flags contradictions, missing references, and stale language before approval.
Validation Suite
CSV and CSA without starting from a blank protocol.
Computerized system validation is still your team’s decision. Yuktav holds the matrix, drafts from your SOP, and keeps IQ, OQ, and PQ evidence attached to the intended use.
- URS to protocol to executed evidence, traced.
- GAMP 5 software categories and risk-based CSA testing.
- Periodic review that starts from what actually changed.
- Change control that knows which validated systems are touched.
Guardrails
Intelligence that an inspector can follow.
Grounded, not guessed
Answers cite your controlled documents and named standards. If the library does not support a claim, Yuktav says so.
People approve
Drafts enter the same review and signature workflow as any other GxP record. Models do not close CAPAs or release documents.
Every prompt is a record
Prompts, retrieved sources, and outputs can be retained with the quality event or validation package they served.
45 minutes
Bring a protocol or an SOP. Leave with a working session.
Forty-five minutes. Bring an SOP, a deviation, or a validation gap.
Book a demo