Intelligence and automation

The regulatory library

FDA guidance and regulations, ICH quality guidelines, EU GMP, EMA and PIC/S, indexed from the official documents so Q Intelligence and Q Agent answer with page-level citations. Add your licensed ISPE and PDA copies.

In the portal: /app/library

Search and cite

  • Search the guidance in the library and filter by issuer, or ask Q Intelligence: answers cite the document, code, page and official link.
  • The catalogue is checked weekly against each issuer; documents that are not final show their status.
  • ISPE (GAMP 5 and guides) and PDA technical reports are listed as licensed publications: choose Add your copy to make your organization's licensed PDF searchable for your users only.
  • Add other documents you are licensed to use with a title, issuer, code and PDF (up to 20 MB).