Agentic QMS

Document management: every QMS document in one place

One searchable index of every document the quality system produces, from controlled documents and validation protocols to risk assessments, change controls, CAPAs, specifications and certificates, with every attached file, and the place an author starts a new document.

In the portal: /app/documents

Start a document as its author

  1. Step 1: Choose New document and the kind: SOP, work instruction, policy, form, specification, protocol, report, master batch record or other controlled document; or a validation plan, protocol or report, a risk assessment, a change control, a CAPA, an investigation or a QC specification.
  2. Step 2: A controlled document opens in Document control with the type preselected and its number assigned from the type's series. You are its author: attach the file under review, add the purpose and keywords, get the AI document review and route the version for approval.
  3. Step 3: The other kinds open on their own pages, where the same rule applies: the person who creates the record is its author and routes it for review and approval.

Tip: The hub stores nothing of its own. Every document is a GxP record of its product, so what you find here is the same record, the same signatures and the same audit trail.

Import legacy documents

Import legacy documents brings your existing approved documents into document control, as their final approved PDF only. One record is created per file.

  1. Step 1: Name the legacy system or archive and the justification for the import, then choose the PDF files.
  2. Step 2: For each file give the legacy document number (it stays the document number), the title, the type, the version, the effective date, who approved it and when, the department, the owner role and the review period.
  3. Step 3: Sign the batch with your email and password: the signature attests that each PDF is the final approved version from the legacy system. The approval itself is not re-created; the PDF is its evidence.

Each imported document is an effective controlled document: found by the search, opened and exported as a controlled copy, due for periodic review from its effective date, and revised like any other by reopening it with a reason, attaching the new draft as the next version and routing it for review and approval.

Rule: A file that is not a PDF, or a document number already in use, is refused. Every import is audited as "Legacy document imported" with the legacy approval details.