Regulatory Dossier and SOP Q&A Assistant

• Head of Quality Assurance
• Regulatory Affairs Manager
• QA Documentation Lead
• Plant Head

A plant can hold thousands of controlled documents: SOPs, work instructions, specifications, validation protocols and the CTD modules filed for each market. When an operator, auditor or regulatory associate needs an answer, they search the DMS by document number and read until they find it, and sometimes they find a superseded version.

We build a retrieval-based assistant that indexes only effective, approved documents from your DMS and regulatory archive, tagged with version, effective date, site and market. Users ask in plain English or Hindi and get a short answer that cites the exact section and page, with a link to the controlled copy. If the documents do not contain the answer, the assistant says so instead of improvising. Access follows your existing roles, so a user at one site cannot retrieve another site's dossiers. The assistant is read-only: it never edits documents and does not replace reading the SOP before executing a task.

• Indexes SOPs, specifications, validation protocols and CTD Modules 2 and 3 by version, site and market
• Answers with section and page citations and opens the controlled copy in the DMS
• Excludes draft, obsolete and withdrawn documents from every answer
• Compares one topic across markets, such as a specification filed in two dossiers
• Filters retrieval by role and site before the model sees any text
• Logs every question, answer and source for QA sampling

1. 01Sync effective documentsA connector pulls approved, effective documents and their metadata from the DMS and regulatory archive on a schedule.
2. 02Parse and indexDocuments are split by section with tables and headings preserved, and indexed with version, site and market tags.
3. 03Ask a questionA user asks in the web app or Microsoft Teams, and retrieval is restricted to what their role allows.
4. 04Retrieve and answerRelevant sections are retrieved and the model drafts a short answer that cites each source passage.
5. 05Check groundingIf retrieved text does not support the answer, or sources conflict, the assistant declines and names the document owner.
6. 06Sample and improveQA samples logged answers each week, marks errors, and retrieval settings are tuned under change control.

1. Document sources
   • DMS connector for effective SOPs and specifications
   • Regulatory archive for CTD modules
   • Metadata sync for version, site and market
2. Indexing
   • Layout-aware parser for tables and headings
   • Section-level vector index
   • Keyword index for document numbers and test names
3. Answering
   • Role-aware retriever
   • LLM answer generator with citation format
   • Grounding and conflict check
4. Access and audit
   • SSO with role and site mapping
   • Question, answer and source log
   • QA sampling dashboard

Document owners decide what gets indexed through the normal DMS approval flow. QA samples logged answers on a fixed schedule and flags errors, and the assistant is positioned as a search aid, not a substitute for reading the controlled SOP.

• Document management system such as Veeva Vault, OpenText or MasterControl (via API or export)
• Regulatory information management or eCTD archive
• Microsoft Teams or an internal web portal
• SSO such as Microsoft Entra ID
• Learning management system for links to training records

• Only effective, approved versions are indexed; drafts and obsolete versions are excluded
• Answers without a supporting citation are blocked
• Retrieval filtered by role, site and market before generation
• Read-only access; the assistant cannot edit or approve documents
• Weekly answer sampling, with errors fed back under change control

• If people rely on its answers in GxP work, the assistant is validated for that intended use and kept under change control, in line with EU GMP Annex 11 and 21 CFR Part 11 expectations.
• Designed to support data integrity by keeping a complete log of questions, retrieved sources and answers.

• Pharma & Life Sciences

  Batch Manufacturing Record Review

  Pre-review of executed batch manufacturing and packaging records that flags blank fields, out-of-limit values, signature gaps and unlinked deviations, with page references, before QA starts.

• Pharma & Life Sciences

  Validation and Security Testing of AI Tools in GxP Settings

  Risk-based testing of LLM and ML tools used in quality, manufacturing or pharmacovigilance: accuracy, prompt injection, data leakage and audit-trail checks, packaged as validation evidence.

• Pharma & Life Sciences

  Certificate of Analysis Extraction and Spec Matching

  Read supplier and in-house certificates of analysis, extract every test result and compare it with your approved specification, so QC sees out-of-limit, missing and mismatched lines at a glance.

• Manufacturing

  Maintenance Log and SOP Assistant

  A shop-floor assistant that answers technicians' questions from breakdown history, OEM manuals and SOPs, in Hindi or English, with the source page or work order behind every answer.