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Built for Compliance. Scaled for Growth

Lot traceability, quality control, and FDA-ready compliance—built in. 
GoldFinch ERP empowers mid-sized medical device and pharmaceutical manufacturers to manage complex supply chains, meet regulatory standards, and bring life-saving products to market faster. 

Powered by Salesforce. Purpose-built for health and life sciences.

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Trusted by Health & Life Science Innovators 

 
 

Eliminate Compliance Gaps and Manual Workarounds 

Paper-based logs and disconnected systems expose your business to audit risk, product recalls, and lost revenue. GoldFinch ERP delivers complete visibility, precision, and control—from R&D through production and fulfillment. 

Full lot/serial traceability from receipt to shipment 
FDA 21 CFR Part 11 and ISO compliance support 
Quality control and test result tracking 
Configurable BOMs and validated manufacturing processes  
Inventory, document, and recall management in one system   

What Health & Life Science Manufacturers
Achieve with GoldFinch ERP 

Lot Traceability & FDA Compliance for Medical Devices

Track every device from raw materials to end-customer. Record lot and serial numbers, component usage, QC results, and shipment data. Instantly identify affected products in the event of a recall. 

Outcome:

FDA and ISO 13485 compliance 
Complete audit trail
Easy recall execution 

Quality Control & Test Result Tracking

Ensure every batch or device meets exacting standards. Automate inspections, store QC results, and prevent release of untested or failed items. 

Outcome:

Reduced non-conformance  
Automated quality holds and release 
Improved audit readiness  

BOM & Batch Record Management

Build and manage multi-level, version-controlled bills of materials. Link electronic batch records (EBR) to work orders, ingredients, and test protocols for total product documentation. 

Outcome:

Accurate builds and documentation  
Faster change control processes 
Reduced rework and deviation risk  

Electronic Signatures & Audit Trails

Enable secure user access, eSignatures, and timestamped logs to meet 21 CFR Part 11 requirements. Maintain chain of custody across production, QA, and shipping. 

Outcome:

Simplified compliance  
Clear accountability 
Lower audit prep time  

Controlled Substance & Cold Chain Tracking

Track controlled drugs, hazardous materials, or temperature-sensitive products by lot, license, and storage condition. Comply with DEA and FDA guidelines.

Outcome:

Accurate handling and documentation  
Reduced spoilage or regulatory violations
Improved public and patient safety 

Recall Management & Regulatory Reporting 

Generate recall lists instantly based on lot data and shipment history. Maintain compliance documents, product history, and automated reporting for FDA or ISO audits.

Outcome:

Faster response to product recalls 
Simplified regulatory inspections 
Reduced legal and reputational risk  

Inventory Visibility by Lot, Expiry, and Status 

Track ingredients, WIP, and finished goods by lot number, expiration date, and QC status. Enforce FEFO logic and prevent release of expired or untested products. 

Outcome:

Improved material control  
Lower write-offs and spoilage
Optimized compliance and shelf life 

Configurable Routing & Work Instructions 

Manage complex device builds or multi-step formulations with detailed routings, inspection points, and digital work instructions. Ensure consistent execution on the shop floor. 

Outcome:

Repeatable processes  
Better training and production quality
Faster new product introduction 

Designed for Mid-Sized Medical Device & Pharmaceutical Companies 

GoldFinch ERP is ideal for life science manufacturers producing:

Surgical tools and implantable devices  
Diagnostic and lab equipment  
FDA-regulated pharmaceuticals and generics  
Nutraceuticals and over-the-counter drugs    
Biotech and medical packaging components    

Download the Life Sciences ERP Brochure   

Learn how GoldFinch helps you stay compliant, scalable, and ready for anything—from FDA inspections to high-volume production.  

Download the Brochure

Ready to Future-Proof Your Life Science Operations? 

Get a demo of GoldFinch ERP for medical device and pharmaceutical manufacturers.

Request a Demo
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