AI-powered FDA inspection readiness

Find the gaps before an FDA investigator does.

Upload an SOP or validation plan. In minutes, InspectGxP returns severity-rated compliance findings benchmarked against 21 CFR Part 11 and FDA Computer Software Assurance (CSA) guidance.

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Gap Assessment: SOP-QA-014Sample output
Critical21 CFR 11.10(e)

No requirement for secure, computer-generated, time-stamped audit trails.

Major21 CFR 11.300

Password aging and periodic credential review are not defined.

MinorFDA CSA Guidance

Testing approach not scaled to intended use or risk.

Illustrative example

How it works

One document in. Clear, prioritized findings out. No setup, no integration project.

1

Upload

Upload one SOP or validation plan in PDF, Word or text format.

2

Assess

Our engine reviews it against 21 CFR Part 11 and FDA CSA expectations, using logic built from decades of hands-on GxP work.

3

Act

Get gap cards rated Critical, Major or Minor, each with the regulatory reference and the evidence behind it.

Built for lean quality teams

Small and clinical-stage biotech and pharma companies face the same FDA expectations as large sponsors, often with a quality team of one or two.

  • Prepare for pre-approval and routine FDA inspections
  • Pressure-test SOPs before a vendor or partner audit
  • Prioritize remediation by risk, not guesswork
  • Get a consultant-grade first pass in minutes, not weeks
Minutes
for a first-pass gap assessment, versus weeks of manual review
2
core frameworks today: 21 CFR Part 11 and FDA CSA
25+
years of GxP expertise behind the regulatory logic

Available now, and what's next

We're focused on doing one thing exceptionally well before we expand.

Gap assessment Available now

Single-document analysis of SOPs and validation plans with severity-rated findings against Part 11 and CSA. Tested against real-world SOPs.

Broader coverage Planned

Additional regulatory frameworks, exportable reports, and readiness scoring. Design partners help shape the roadmap.

Built by practitioners, not just technologists

InspectGxP is built and owned by Sharp Logiq, a boutique GxP advisory and quality systems consulting firm specializing in CSV/CSA, QMS design and platform migration, and inspection readiness.

The regulatory logic behind InspectGxP reflects more than 25 years of hands-on delivery for global pharmaceutical and biotech organizations.

Visit Sharp Logiq

Become an early design partner

We're working with a small group of biotech and pharma quality leaders to shape InspectGxP. Send one SOP and see what it finds.

Contact taruns@sharplogiq.com