DataNinja ERP Compliance Overview
How DataNinja Supports Regulated Industries
Use this page to compare DataNinja ERP functionality with common regulatory requirement areas across regulated manufacturing, warehousing, quality, and distribution workflows.
DataNinja ERP supports workflows across multiple regulated industries, including dietary supplements, food and beverage, pharmaceuticals, medical devices, cosmetics, and biotech.
The table below provides a high-level mapping of common regulatory requirement areas and how DataNinja functionality supports those expectations through system configuration, role-based access, material controls, electronic records, audit trails, labeling, batch execution, and traceability.
Use the first column to identify the DataNinja requirement area, then review the applicable industry columns for related regulatory references.
| DataNinja Requirement Compliance | Dietary Supplements Regulatory Mapping | Food & Beverage Regulatory Mapping | Drug Regulatory Mapping | Medical Device Regulatory Mapping | Cosmetics Regulatory Mapping | Biotech Regulatory Mapping |
|---|---|---|---|---|---|---|
| User Access, QA Role Separation, and GMP Action Authorization | 21 CFR 111.12; 111.13; 111.35; 111.117; 111.120 | 21 CFR 117.4; 117.305; 117.315 | 21 CFR 211.22; 211.25; 211.68; 211.180 | 21 CFR 820.10; 820.35 | FDA cosmetic GMP guidance; MoCRA records/accountability framework | 21 CFR 211.22; 211.25; 211.68; 211.180; 21 CFR 1271.170 if HCT/P applies |
| Facility/Location Controls and Material Movement Restrictions | 21 CFR 111.15; 111.20(d) | 21 CFR 117.20; 117.35; 117.80 | 21 CFR 211.42; 211.56; 211.80 | 21 CFR 820.10 | FDA cosmetic GMP guidance: premises, storage, contamination prevention; 21 CFR 700 as applicable | 21 CFR 211.42; 211.56; 211.80; 21 CFR 600.10; 21 CFR 1271.195 if HCT/P applies |
| Automated System Controls, Audit Trail, Backup, and Secure Records | 21 CFR 111.117; 111.120; 111.605–111.610 | 21 CFR 117.305; 117.315 | 21 CFR 211.68; 211.180; 211.188; 211.194 | 21 CFR 820.10; 820.35 | FDA cosmetic GMP guidance; MoCRA records framework | 21 CFR 211.68; 211.180; 211.188; 21 CFR 600.12; 21 CFR 1271.270 if HCT/P applies |
| Receiving, Incoming Inspection, Disposition, and Nonconforming Material Control | 21 CFR 111.75; 111.155–111.160; 111.165–111.170 | 21 CFR 117.80; 117.135; 117.150 | 21 CFR 211.80; 211.84; 211.89; 211.110; 211.192 | 21 CFR 820.10; 820.35 | FDA cosmetic GMP guidance: raw material receipt, testing, quarantine/rejection, storage controls | 21 CFR 211.80; 211.84; 211.89; 211.110; 21 CFR 1271.210; 1271.265 if HCT/P applies |
| Label Generation, Barcode Control, and Label Traceability | 21 CFR 111.410–111.430 | 21 CFR 117.80; 117.130; 117.305 | 21 CFR 211.122; 211.125; 211.130 | 21 CFR 820.45 | FDA cosmetic GMP guidance: labeling control; 21 CFR 701 as applicable | 21 CFR 211.122; 211.125; 211.130; biologics labeling controls as applicable under 21 CFR Subchapter F |
| MMR Configuration, Process Controls, and QA Approval | 21 CFR 111.205–111.210 | 21 CFR 117.80; 117.135 | 21 CFR 211.100; 211.110; 211.186 | 21 CFR 820.10 | FDA cosmetic GMP guidance: production/process controls and manufacturing instructions | 21 CFR 211.100; 211.110; 211.186; biologics process controls as applicable under 21 CFR 600/610 |
| Expiration Dating and Status-Based Usage Restrictions | 21 CFR 111.465 | 21 CFR 117.80 | 21 CFR 211.137; 211.166; 211.84 | 21 CFR 820.10; 820.35 | FDA cosmetic GMP guidance: stability/expiration or retest controls where used | 21 CFR 211.137; 211.166; 21 CFR 610.53 where applicable |
| Batch Production Record Execution and Traceability | 21 CFR 111.255–111.260 | 21 CFR 117.80; 117.305 | 21 CFR 211.188; 211.192 | 21 CFR 820.35; 820.45 | FDA cosmetic GMP guidance: batch/production records | 21 CFR 211.188; 211.192; biologics batch records as applicable |
| Returned Material Control | 21 CFR 111.165(c); 111.170 | 21 CFR 117.150 | 21 CFR 211.204; 211.208 | 21 CFR 820.35; 820.45 | FDA cosmetic GMP guidance: returned material and complaint-related record controls where applicable | 21 CFR 211.204; 211.208; 21 CFR 1271.265 if HCT/P applies |
| End-to-End Traceability / Mock Recall | 21 CFR 111.75; 111.95; 111.260; 111.605–111.610 | 21 CFR 117.80; 117.305; 117.315 | 21 CFR 211.84; 211.188; 211.196 | 21 CFR 820.35; 820.45 | Cosmetic GMP guidance; MoCRA records framework; 21 CFR 700/701 as applicable | 21 CFR 211.84; 211.188; 211.196; 21 CFR 600.12; 21 CFR 1271.270 if HCT/P applies |
| Critical Audit Trail Review | 21 CFR 111.117; 111.120; 111.605–111.610 | 21 CFR 117.305; 117.315 | 21 CFR 211.68; 211.180; 211.188; 211.194 | 21 CFR 820.35 | Cosmetic GMP guidance; MoCRA records framework | 21 CFR 211.68; 211.180; 21 CFR 600.12; 21 CFR 1271.270 |
| Interface Accuracy and Exception Handling | 21 CFR 111.117; 111.120; 111.155–111.160; 111.605–111.610 | 21 CFR 117.80; 117.305; 117.315 | 21 CFR 211.68; 211.80; 211.84; 211.180 | 21 CFR 820.35; 820.45 | Cosmetic GMP guidance; MoCRA records framework | 21 CFR 211.68; 211.80; 211.84; 21 CFR 600.12; 21 CFR 1271.270 |
| Equipment Status / Maintenance Lockout | 21 CFR 111.25; 111.27; 111.30; 111.35 | 21 CFR 117.35; 117.40 | 21 CFR 211.63; 211.67; 211.68 | 21 CFR 820.10; 820.35 | Cosmetic GMP guidance: equipment, maintenance, and calibration where applicable | 21 CFR 211.63; 211.67; 211.68; 21 CFR 600.11 |
| Data Migration Verification | 21 CFR 111.605–111.610 | 21 CFR 117.305; 117.315 | 21 CFR 211.68; 211.180 | 21 CFR 820.35 | Cosmetic GMP guidance; MoCRA records framework | 21 CFR 211.68; 211.180; 21 CFR 600.12; 21 CFR 1271.270 |
| Rejected / Expired Material Shipping Restriction | 21 CFR 111.165; 111.170; 111.465 | 21 CFR 117.80; 117.150 | 21 CFR 211.84; 211.89; 211.137; 211.150 | 21 CFR 820.45 | Cosmetic GMP guidance: storage, rejected/expired materials, distribution controls | 21 CFR 211.84; 211.89; 211.137; 211.150; 21 CFR 600.15 where shipment conditions apply |
These regulatory mappings provide general compliance context for DataNinja functionality. Actual compliance depends on each customer’s system configuration, procedures, assigned roles and permissions, and quality-system review practices.
For customer-specific questions, DataNinja Support can explain how a feature works, how a workflow can be configured, and what system records are available to support traceability, review, and compliance activities.
DataNinja also includes functionality that supports electronic records, electronic signatures, audit trails, access controls, and record integrity expectations commonly associated with 21 CFR Part 11 and EU Annex 11.
Updated 16 days ago