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GMP & GDP Compliance Toolkit: FDA 21 CFR 820 Gap Assessment and Batch Records

GMP GDP Compliance Toolkit — 150+ point gap assessment, GDP qualification checklist, batch record template, deviation SOP, GMP training matrix, and inspection readiness assessment.

$1976+$247

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What's Inside

6 templates, SOPs, and checklists
ready to customize

Built from analysis
of real FDA 483 observations

Average implementation: 2–3 days
(vs. 4–6 weeks with a consultant)

GMP Gap Assessment Checklist (21 CFR 820 QMSR + ISO 13485)

GDP Qualification and Distribution Controls Checklist

Batch/Lot Record Template (FDA 21 CFR 820.184 DHR)

Deviation and Out-of-Specification Investigation SOP

GMP Training Matrix and Competency Framework

GMP Regulatory Inspection Readiness Assessment

FREE BONUSES

Plus You'll Get These Bonuses Free

$47 Value

FDA Inspection Readiness Checklist

27-point checklist based on real 483 observations

$97/year Value

Quarterly Regulatory Updates

Free updates when FDA guidance changes

$29 Value

Implementation Quick-Start Guide

Step-by-step instructions to deploy templates in your QMS

Total Bonus Value: $173+ — Yours FREE with purchase

Benefits

150+ assessment points covering every QMSR and ISO 13485 requirement with risk ratings

DHR-compliant batch record template satisfies FDA 21 CFR 820.184 out of the box

Deviation SOP includes severity classification and CAPA initiation triggers

Inspection readiness assessment covers the 10 most-cited GMP deficiencies

What QA/RA Professionals Say

Join 500+ medical device companies using RegWatchDaily templates

“These templates saved us months of work. We passed our FDA inspection on the first try.”

Sarah M.

QA Director, Class II Orthopedic Company

50-person manufacturer

“Finally, templates that actually reflect how FDA inspectors think. Worth every penny.”

Michael T.

RA Manager, Contract Manufacturer

ISO 13485 certified

“We've used consultant templates before. These are better — more practical, less fluff.”

Jennifer L.

VP Quality, Startup

Series A medical device company

Is This For You?

This toolkit is designed for teams facing these challenges:

GMP gaps identified during FDA inspection rather than before

Batch records missing required DHR elements under 21 CFR 820.184

Deviation investigation process inconsistent across manufacturing shifts

Inspection team not prepared for FDA investigator questions during facility walkthrough

Who This Is For

VP Operations responsible for GMP complianceQA managers building or upgrading manufacturing quality systemsRegulatory affairs leads preparing for FDA facility inspectionsContract manufacturers qualifying under a Quality Agreement

The Audit-Ready Guarantee

Try the toolkit for 7 full days. If you don't feel more confident about your next FDA inspection, email us and we'll refund every penny — no questions asked. You keep the templates.

Your investment is 100% protected.

Frequently Asked Questions

Does this cover the new FDA QMSR?

Yes. The gap assessment is aligned with both legacy 21 CFR Part 820 and the updated Quality Management System Regulation (QMSR) that harmonizes FDA requirements with ISO 13485:2016.

Is this applicable to contract manufacturers?

Yes. The gap assessment and batch record templates apply to both finished device manufacturers and CMOs operating under a Quality Agreement.

What file format are the templates in?

All templates are provided in editable Microsoft Word (.docx) format. You can customize them to match your company's branding and specific requirements.

How quickly will I receive the files?

Instantly. After purchase, you'll receive an email with download links within 2-3 minutes. Check your spam folder if you don't see it.

Can I use these for multiple projects or clients?

Yes. Your purchase includes a company-wide license. Use the templates across all your projects and devices within your organization.

Do these templates get updated when regulations change?

Yes. You'll receive free updates via email whenever we update templates for new guidance or regulatory changes.

What if I need help customizing the templates?

Email us at support@regwatchdaily.com. We typically respond within 24 hours with guidance on customization.

Is there a money-back guarantee?

Yes — the Audit-Ready Guarantee. If you're not satisfied within 7 days, email us for a full refund. No questions asked.

Ready to Get Audit-Ready?

GMP & GDP Compliance$247

+ FDA Inspection Readiness Checklist$47

+ Quarterly Regulatory Updates$97/year

+ Implementation Quick-Start Guide$29

Total Value$420+

Your Price Today$247

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