Regulatory Compliance

Mar-Kov drives traceability, compliance, and audit readiness for batch manufacturers. We power your operations with built-in GMP controls, automated documentation, and end-to-end visibility. Mar-Kov equips you to meet FDA, GFSI, and Health Canada requirements, and eliminates manual workarounds so you pass every government, brand, retailer, and certification audit. 

Regulatory Compliance with Mar-Kov

Trusted by:

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What Our Clients Are Saying

“

Our formulas are the very foundation of our business and we like knowing they can’t get lost or corrupted, Mar-Kov’s ability to store and instantly access everything from finished goods batch numbers to raw material inventory, and chemical specifications really sold us because it gives us complete control and transparency

Stephanie KellyQuality Manager, Titan Coatings International
“

After 10+ years of using the same software, we were very reluctant to change. With Mar-Kov, things have worked out better than expected – we replaced all the functionality we had under our old software and have added new capabilities as well. Now we are in a really good place

John DalyPresident of Surfacelogix
“

With Mar-Kov, we’re more in the loop and more informed about our business and manufacturing processes. Mar-Kov has more data which is better because it provides insights and answers if anyone in management has a question.

Lucas BerryDirector of Operations, Acrylux Paint Mfg. Co

Protect Your Business with Mar-Kov’s
Built-In Compliance Support

Always Audit-Ready

  • Automatically capture every step of production—no detail missed. 
  • Generate required records instantly for any inspection. 
  • Eliminate last-minute scrambling and stay calm under audit pressure. 
  • Maintain complete electronic batch records without extra effort. 
  • Access historical compliance data at any time, from anywhere. 
  • Pass both scheduled and surprise audits with confidence. 
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Proactive Error Prevention

  • Enforce SOPs with barcode scanning and integrated scales. 
  • Real-time checks for approvals, tests, and Certificates of Analysis (CoAs). 
  • Catch and correct mistakes before they leave the production floor. 
  • Block non-compliant materials from entering production. 
  • Capture operator sign-offs on formulation defined steps.  
  • Ensure all compliance-critical steps are fully documented. 
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One-Click Regulatory Documentation
Earn Trust. Expand Access.

Earn Trust. Expand Access.

  • Demonstrate compliance to customers, partners, and regulators. 
  • Open doors to new certifications and market opportunities. 
  • Build a brand known for quality and reliability. 
  • Strengthen relationships with high-value retail partners. 
  • Increase eligibility for global distribution agreements. 
  • Use compliance as a competitive market advantage. 
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One-Click Regulatory Documentation

  • Instantly produce compliant EBRs, CoAs, and lot history reports. 
  • Eliminate manual data entry and reduce risk of errors. 
  • Save hours of prep before audits or customer requests. 
  • Auto-populate regulatory forms with live production data. 
  • Generate full SDS documentation in seconds. 
  • Keep a centralized, searchable archive of all compliance files.
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One-Click Regulatory Documentation

99.9%

Inventory accuracy year over year

2X

Production without hiring additional staff

30%

Improvements in margins

60

Seconds to run a mock recall

12

Months ROI

Ready to simplify your Regulatory Compliance?

Talk to a Mar-Kov Expert for free

Drive Growth With These Key Benefits

1

Always Audit-Ready

Automatically capture every production step. Generate all required documentation so you're never scrambling for a surprise inspection. Stay compliant, calm, and in control.
2

Proactive Error Prevention

Enforce SOPs with barcode scanning, integrated scales, and real-time checks for approvals, testing, and CoAs, so mistakes are caught before they happen.
3

One-Click Regulatory Documentation

Instantly generate compliant EBRs, CoAs, SDSs, and full lot history reports. No more manual errors. No more late nights before audits.
4

Global Compliance Built-In

Stay aligned with FDA, GFSI, FSMA, Health Canada, and 21 CFR Part 11. Whether you're selling locally or globally, Mar-Kov keeps you covered.
5

Supplier & Ingredient Certification Tracking

Track, verify, and manage all vendor and raw material certifications. Avoid costly oversights and keep your supply chain compliant.
6

Earn Trust. Expand Access.

Demonstrate your compliance posture to partners, retailers, and regulators; building trust and unlocking access to new certifications and markets.

Expertise Across Industries

Food 

Stay compliant with GFSI, FSMA, and retailer standards by automating sanitation checks, allergen controls, and end-to-end traceability with audit-ready digital batch records.

Ice Cream 

Manage dairy allergens, temperature-sensitive ingredient tracking, and clean-in-place (CIP) validation to meet FDA and SQF standards, while generating mock recall reports in minutes.

Chemicals 

Track hazardous materials and generate compliant SDSs. Maintain OSHA, WHMIS, and international chemical labeling standards with complete batch traceability.

Cosmetics 

Meet clean-label, INCI, and GMP requirements with electronic batch records, verified raw material certificates, and allergen management tailored for regulatory inspections and private-label compliance.

Pharmaceuticals 

Enforce 21 CFR Part 11 with secure access, digital signatures, and full audit logs. Ensure every process step, from formulation to QA release, meets GMP and FDA expectations.

Beverages 

Comply with FDA, CFIA, and HACCP standards by enforcing SOPs for cleaning validation, lot tracking, and raw material approvals in both carbonated and non-carbonated production lines.

Alcohol 

Maintain excise audit trails, fermentation logs, and cleaning records to satisfy federal and provincial alcohol manufacturing regulations, while proving ingredient traceability.

Commercial Bakery 

Meet GFSI and allergen separation standards with barcode-driven ingredient tracking, FIFO enforcement, and instant document generation for regulatory and brand audits.

Dietary Supplements 

Support both FDA and Health Canada regulations by automating CoA validation, traceability, and GMP-required documentation across formulas, suppliers, and production batches.

Paints & Coatings 

Stay compliant with VOC, SDS, and hazard labeling regulations. Generate compliance reports and audit logs across solvent-based and water-based product lines.

Unlock More Powerful Features

Work Smarter With Seamless Integrations

mar-kov and shopify integration
mar-kov and shipstation integration

Frequently Asked Questions

Is Mar-Kov compliant with 21 CFR Part 11 for electronic records?

Yes. Mar-Kov fully supports 21 CFR Part 11, including secure user authentication, electronic signatures, role-based access, and tamper-proof audit trails to meet FDA requirements. 

Can I generate regulatory documents like CoAs, EBRs, and SDSs directly in the system?

Absolutely. Mar-Kov automates the generation of Certificates of Analysis (CoAs), Electronic Batch Records (EBRs), Safety Data Sheets (SDSs), and other compliance reports with a single click. 

How does Mar-Kov help prevent compliance errors before they happen?

We use barcode-driven SOP enforcement, integrated scale checks, and real-time validations to catch issues like incorrect ingredient usage or out-of-spec weights before they impact your batch. 

What regulations and standards does Mar-Kov support?

Mar-Kov supports compliance with FDA, GFSI, FSMA, Health Canada, 21 CFR Part 11, and a variety of industry-specific standards across cosmetics, supplements, food, pharma, chemicals, and more. 

Can I track supplier documents and material certifications?

Yes. You can upload, manage, and auto-expire vendor documents including CoAs, allergen declarations, SDSs, and organic certifications—all linked directly to raw materials and lots.