Free · No signup · Results in 60 seconds

Know exactly what you need to get ISO 9001 or GMP certified.

Enter your industry and location. Get a complete list of documents to create, processes to build, and a week-by-week implementation plan — tailored to your exact regulatory context.

  • Exact documents and processes — not a generic checklist
  • Jurisdiction-aware: federal + your state's specific rules
  • Top 5 audit risks highlighted with what inspectors check for

Jurisdiction-tagged requirements

Intl · ISOFederal · FDAFederal · EPAState · Cal/OSHAState · TCEQ

Covers regulations from

FDAISOOSHAEPAState Agencies
7Certification FrameworksISO 9001 · GMP · HACCP · ISO 45001 · more
198+Requirements MappedAcross all frameworks
14Industries CoveredPharma · food · biotech · devices
50US StatesFederal + state-level rules
How it works

From intake to roadmap in 30 seconds

No consultants. No jargon PDFs. Just precise, actionable compliance intelligence — instantly.

🏢
01

Describe your business

Enter your industry, location, company size, and target certifications. Takes under 30 seconds.

02

We map your requirements

Our engine matches your profile against 198+ requirements across ISO 9001, GMP, HACCP, and more — filtered to your exact jurisdiction.

📋
03

Get your readiness report

A complete list of documents to create, processes to build, your top 5 audit risks, and a phased implementation plan. See a sample below.

No account required. Takes under 30 seconds.

Sample report

Here's what your report looks like

This is actual output for a biomanufacturing company targeting GMP certification in Newark, NJ — 100 employees.

Your certification plan · Acme Biosciences · GMP + ISO 9001

Documents to prepare

52

Templates, records, plans

Processes to build

16

SOPs to formalize

Estimated timeline

24 wks

Across 4 phases

⚡ Start Here · Priority action 2 of 5

2
critical21 CFR §211.68 / §211.34

Establish Personnel Qualifications and GMP Training Program

All personnel must receive documented GMP training appropriate to their role before performing GMP activities.

🔍 What auditors check

FDA investigators request training records for all cGMP-critical roles. They verify training is role-specific, documented, and dated before the employee performed any GMP task.

⚠️ Risk if not addressed

Form 483 observation. Warning Letter for systemic training failures. Inability to demonstrate personnel competency can halt production operations.

Implementation roadmap · 4 phases · ~24 weeks

1

Prepare documentation

~8 weeks

2

Implement workflows

~10 weeks

3

Internal audit

~2 weeks

4

Certification audit

~4 weeks

+ 49 requirements · 11 applicable regulations · OSHA, FMLA & EEO-1 obligations based on headcount

No account required. Takes under 30 seconds.

Industry coverage

Built for regulated industries, not generic businesses

Each industry has a tailored requirement set. Your profile never gets someone else's compliance obligations.

🧬
Biomanufacturing / Biotech
ISO 9001ISO 14001GMP21 CFR 600
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Pharmaceutical Distribution
GMPGDPISO 9001
⚕️
Medical Device Manufacturing
ISO 900121 CFR 820ISO 14971
🧪
Chemical / API Manufacturing
ICH Q7ISO 9001ISO 14001
🏭
Advanced Manufacturing
ISO 9001GMPISO 14001
🍱
Food Production & Distribution
HACCPFSMAISO 9001
🔋
Battery Storage & Energy
ISO 9001ISO 14001DOT HMR
📦
Warehousing & Logistics
ISO 9001ISO 14001GDP
Free · No signup required

Ready to know your compliance requirements?

Stop guessing. Start with a precise compliance map built for your exact industry, location, and certification goals.

Takes under 30 seconds. No account required.