Regulatory Standards We Support
Whether you're preparing for a BRC audit, responding to an FDA inspection, or maintaining ISO certification, Trace Swift provides the batch records and traceability that regulators expect.
Every feature—from batch capture to forward traceability—is built with compliance in mind. When auditors ask questions, you'll have answers ready.
🇺🇸 FDA FSMA
United States
The Food Safety Modernization Act Rule 204 requires enhanced traceability for foods on the Food Traceability List. Trace Swift helps you capture Critical Tracking Events and Key Data Elements.
- Sub-4-hour trace capability
- Critical Tracking Events capture
- Key Data Elements recording
- Digital recordkeeping
- Lot-level traceability
🇬🇧 BRC Global Standards
United Kingdom / International
BRC Food Safety Issue 9 Section 3.9 requires full traceability of all raw materials through to finished products, plus mass balance verification.
- Complete batch traceability
- Mass balance verification
- Traceability test documentation
- Supplier approval records
- Non-conformance tracking
🌍 FSSC 22000
International
FSSC 22000 builds on ISO 22000 with additional requirements for food safety management. Trace Swift supports the traceability elements of Clause 8.9.
- End-to-end traceability
- Non-conformity tracking
- Temperature monitoring
- Production batch records
- Supplier verification
🇪🇺 IFS Food
European Union
IFS Food Section 4.18 requires traceability systems that can identify all lots within 2 hours for short shelf-life products. Trace Swift makes this achievable in minutes.
- 2-hour trace capability
- EU Regulation 178/2002 alignment
- Mass balance reconciliation
- Allergen traceability
- Affected product identification
📋 ISO 22000
International
The international standard for food safety management systems. Trace Swift supports the traceability and documentation requirements throughout Clause 8.
- Traceability procedures
- Product identification
- Withdrawal procedures
- Record management
- Verification activities
🇪🇺 EU Food Law 178/2002
European Union
The foundational EU regulation requiring traceability at all stages of production, processing, and distribution. Trace Swift provides one-step-back, one-step-forward capability.
- One-step-back traceability
- Forward traceability to finished products
- Supplier identification
- Batch/lot identification
- Recall capability
🏭 GMP (Good Manufacturing Practice)
International
GMP requirements span food, pharmaceutical, and cosmetics manufacturing. Trace Swift supports the batch record and traceability elements common across GMP frameworks.
- Production batch records
- Production audit trails
- Quality control records
- Temperature recording
- Personnel attribution
🔬 HACCP
International
Hazard Analysis Critical Control Points is the foundation of food safety systems worldwide. Trace Swift supports HACCP documentation through production capture and quality records.
- Critical control point records
- Temperature monitoring
- Corrective action documentation
- Verification records
- Batch-level quality checks
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Start Free 14-Day TrialFDA FSMA Rule 204
The Food Safety Modernization Act (FSMA) Rule 204 establishes enhanced traceability requirements for foods on the Food Traceability List (FTL). Manufacturers handling these products must capture specific data elements at Critical Tracking Events throughout the supply chain.
How Trace Swift Supports FSMA Compliance
✓ Critical Tracking Events
Trace Swift captures the CTEs that matter: receiving, transformation (production), and shipping. Each event is timestamped with the required data elements automatically recorded.
✓ Key Data Elements
Lot codes, quantities, locations, and dates are captured at each CTE. Our goods receipt and production capture screens are designed to collect exactly what FDA requires.
✓ Traceability Lot Codes
Internal lot numbers and supplier batch codes are linked throughout the system. Both forward and backward tracing use these codes to establish complete genealogy.
✓ Sub-4-Hour Tracing
FDA requires the ability to trace products within specific timeframes during inspections. Trace Swift's instant search typically completes traces in under 5 minutes.
✓ Digital Records
Electronic records are sortable, searchable, and exportable. No more digging through paper files during inspections—find any batch instantly.
✓ Supplier Traceability
Link every input lot to its source supplier, purchase order, and received date. Maintain the one-step-back traceability that FDA expects.
BRC Global Standards
BRC Food Safety Issue 9 sets rigorous requirements for traceability systems. Section 3.9 requires manufacturers to demonstrate full traceability of raw materials through to finished products, including mass balance verification and regular traceability testing.
How Trace Swift Supports BRC Compliance
✓ Full Traceability
Trace any batch backward to all source inputs or forward to all finished products where it was used. Complete genealogy in seconds, not hours.
✓ Mass Balance Verification
Compare input quantities against output quantities to verify yields and identify losses. Automatic variance alerts when discrepancies exceed acceptable thresholds.
✓ Traceability Testing
Run mock traces anytime to verify your system works. Document the results with timestamps for your traceability test records—auditors love seeing regular testing.
✓ Supplier Approval
Maintain approved supplier lists with status tracking. Record approval dates, review dates, and approval criteria for each supplier relationship.
✓ Non-Conformance Records
Quality hold, rejection, and release workflows create the documentation trail for non-conforming products. Batch status tracking shows the complete history.
✓ 4-Hour Trace Requirement
BRC expects traceability within 4 hours. With Trace Swift, most traces complete in under 5 minutes—giving you time to spare for investigation and response.
FSSC 22000
FSSC 22000 combines ISO 22000 with additional requirements for food safety management. The scheme requires robust traceability systems that enable rapid identification and recall of affected products.
How Trace Swift Supports FSSC 22000 Compliance
✓ End-to-End Traceability
From raw material receipt through production to finished goods, every step is documented. Complete chain of custody for all materials.
✓ Identification & Traceability (8.3)
Unique batch identification throughout processing. Internal lot numbers linked to supplier codes ensure products can be traced at every stage.
✓ Control of Nonconformities (8.9)
Quality hold and rejection workflows with full documentation. Corrective action records linked to specific batches for complete traceability.
✓ Withdrawal Procedures
Forward traceability identifies exactly which finished products contain a specific input lot. Targeted withdrawals instead of broad recalls.
✓ Verification Records
Quality inspection records, production checks, and verification activities are documented with timestamps and personnel attribution.
✓ Continual Improvement
Production data, quality records, and traceability tests provide the information needed to identify improvement opportunities.
IFS Food
IFS Food Standard Section 4.18 requires traceability systems that comply with EU Regulation 178/2002. For short shelf-life products, the standard requires trace capability within 2 hours—Trace Swift makes this achievable in minutes.
How Trace Swift Supports IFS Food Compliance
✓ 2-Hour Trace Capability
IFS requires rapid tracing for time-sensitive products. Trace Swift's instant search means you can identify affected batches in under 5 minutes.
✓ EU 178/2002 Alignment
One-step-back and one-step-forward traceability as required by EU Food Law. Link inputs to suppliers and outputs to customers.
✓ Mass Balance Testing
Verify input quantities against output quantities with documented variance analysis. Essential for IFS traceability assessments.
✓ Allergen Traceability
Track allergen-containing inputs through to finished products. Identify all batches potentially affected by allergen cross-contact.
✓ Product Withdrawal Support
Quickly identify affected products for targeted withdrawals. Forward traceability enables efficient, focused recalls rather than broad withdrawals.
✓ Annual Traceability Tests
IFS requires annual traceability testing. Run mock traces regularly and document the results with full audit trails.
ISO 22000
ISO 22000 is the international standard for food safety management systems. Clause 8 establishes requirements for traceability, product identification, and control of nonconforming products that Trace Swift is designed to support.
How Trace Swift Supports ISO 22000 Compliance
✓ Traceability System (8.3)
Documented traceability procedures with unique identification of materials and products at all stages of production.
✓ Product Identification
Internal lot numbers, supplier batch codes, and product batch codes provide unique identification throughout the supply chain.
✓ Documented Information (7.5)
Digital records maintained for batch production, quality inspections, and traceability activities. Searchable, secure, and audit-ready.
✓ Withdrawal & Recall (8.9.5)
Forward and backward traceability enables rapid identification of affected products. Support for withdrawal procedures and notification.
✓ Monitoring & Measurement
Temperature recording, quality checks, and verification activities documented at the batch level with timestamps.
✓ Corrective Actions
Non-conformance records linked to specific batches. Quality hold and release workflows document corrective action effectiveness.
EU Regulation 178/2002
EU Food Law Regulation 178/2002 establishes the foundational traceability requirements for food businesses operating in the European Union. Article 18 requires traceability at all stages of production, processing, and distribution.
How Trace Swift Supports EU 178/2002 Compliance
✓ One-Step-Back
Identify all suppliers of inputs used in any product. Trace Swift links every production batch to its source materials and suppliers.
✓ Forward Traceability
Identify which finished products contain specific input lots. Customer despatch tracking integrates with your invoicing system.
✓ Supplier Identification
Maintain records of suppliers for all inputs. Purchase orders, goods receipts, and supplier details documented in one system.
✓ Batch Identification
Lot and batch identification throughout production. Internal lot numbers linked to supplier batch codes for complete traceability.
✓ Rapid Traceability
Competent authorities expect rapid response. Trace Swift's instant search provides the information you need in minutes.
✓ Record Retention
Digital records maintained and accessible. Cloud-based storage ensures records are available when authorities require them.
Good Manufacturing Practice (GMP)
GMP requirements vary by industry—FDA 21 CFR Part 211 for pharmaceuticals, Part 117 for food, and Part 111 for dietary supplements. Despite differences, all share common requirements for batch documentation and traceability that Trace Swift supports.
How Trace Swift Supports GMP Compliance
✓ Batch Records
Complete production records for every batch: inputs used, quantities, personnel, timestamps, and quality checks. Digital batch records replace paper logs.
✓ Audit Trails
Track who did what and when. Production capture, quality inspections, and batch releases are attributed to specific users with timestamps.
✓ Component Traceability
Every input lot is traced to its source and forward to all products where used. Complete genealogy for raw materials and components.
✓ Quality Records
Goods receipt inspection, in-process checks, and release decisions documented with reasons and attributions.
✓ Process Recording
Temperature recording and production notes capture processing conditions. Batch records document the production environment.
✓ Training Support
Simple, intuitive interface means less training time. New staff can be productive quickly, reducing documentation errors.
HACCP
Hazard Analysis Critical Control Points (HACCP) is the foundation of food safety systems worldwide. Trace Swift supports HACCP documentation through production capture, temperature recording, and quality verification records.
How Trace Swift Supports HACCP Documentation
✓ CCP Monitoring Records
Document critical control point measurements at the batch level. Temperature recording with automatic alerts when limits are exceeded.
✓ Temperature Recording
Capture cooked and chilled temperatures with timestamps. Visual alerts highlight temperatures outside safe ranges for immediate corrective action.
✓ Corrective Actions
Document corrective actions linked to specific batches. Quality hold and release workflows provide the audit trail HACCP requires.
✓ Verification Activities
Quality inspection records, production checks, and traceability tests support HACCP verification requirements.
✓ Batch-Level Documentation
Every production batch has complete documentation: inputs, processes, checks, and outcomes. Ready for HACCP review.
✓ Supplier Verification
Approved supplier lists, goods receipt inspection, and quality records support supplier verification as part of your HACCP system.
Compliance Features at a Glance
Every standard requires specific capabilities. Here's how Trace Swift maps to common compliance requirements:
Traceability
Required by all standards
- Forward traceability (input → products)
- Backward traceability (product → inputs)
- Dual code system (supplier + internal)
- Universal batch search
- Sub-5-minute trace times
Documentation
Required by all standards
- Batch production records
- Goods receipt records
- Quality inspection records
- Personnel attribution
- Timestamped audit trails
Recall Readiness
Required by all standards
- Rapid affected product identification
- Targeted vs. broad recall support
- Mock recall testing
- Batch status tracking
- Supplier traceability records
Quality Control
Required by most standards
- Goods receipt inspection
- Production quality checks
- Temperature recording
- Non-conformance handling
- Release/rejection workflows
Common Questions
Is Trace Swift certified for specific standards?
Trace Swift is a tool that helps you meet compliance requirements—the certification applies to your facility, not the software. We design our features around the documentation and traceability requirements of major standards, so you have the records auditors expect to see.
Can Trace Swift replace our current documentation?
For batch traceability, production records, and quality inspection records, yes.
What about FDA 21 CFR Part 11 electronic records?
Trace Swift provides user authentication, audit trails, and timestamped records. For full Part 11 compliance, organisations typically need additional controls around electronic signatures and system validation. Contact us to discuss your specific requirements.
How do auditors respond to Trace Swift?
Auditors appreciate digital systems that provide instant access to batch records and traceability information. The ability to run a trace in minutes rather than hours makes a positive impression—and reduces stress during inspections.
What if my standard isn't listed here?
Most food safety and quality standards share common traceability requirements. If your standard requires batch identification, lot traceability, production documentation, and quality records, Trace Swift likely supports it. Contact us to discuss your specific certification.
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