Quality & Regulatory Compliance
At WellPact, quality and security aren’t just policies—they’re commitments we uphold every day. Partner with us for secure, compliant, and industry-leading healthcare fulfillment.
A Partner You Can Trust
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Quality & Compliance
At WellPact, quality, compliance, and security are the foundation of everything we do. Our commitment to regulatory excellence ensures that every product we handle meets the highest standards for safety, accuracy, and confidentiality. With rigorous quality management, strict security protocols, and an ISO 13485-certified system, we provide trusted healthcare fulfillment solutions that protect both our clients and their patients.
ISO 13485
Certified
Meeting the highest standards for healthcare fulfillment excellence.
FDA-Registered Facility
Operating with strict regulatory compliance for safety and quality.
Security & Data Protection
Protecting sensitive data with advanced security and strict protocols.
Quality Management System
Guaranteeing accuracy, compliance, and reliability in every fulfillment process.
ISO 13485 Certified
Meeting the Highest Standards in Healthcare Fulfillment
WellPact operates under an ISO 13485-certified Quality Management System, the globally recognized standard for medical device fulfillment. This certification reflects our commitment to:
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Stringent quality control measures
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Risk management and regulatory compliance
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Continuous improvement in processes to meet evolving healthcare needs
Our adherence to ISO 13485 ensures that every product we handle meets the highest quality and safety requirements, reducing risk and enhancing reliability for our partners.
What is ISO 13485?
ISO 13485 is the global benchmark for medical device quality management systems (QMS). It sets requirements for:
✔ Risk-based approach to fulfillment and distribution
✔ Process consistency to maintain quality across all operations
✔ Regulatory compliance to meet FDA and global standards
✔ Continuous improvement through regular audits and process refinement
How WellPact Implements ISO 13485
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End-to-end traceability: Every step of the fulfillment process is documented, ensuring compliance and accuracy.
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Standardized operating procedures (SOPs): Clearly defined workflows reduce errors and ensure consistency.
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Rigorous quality checks: From incoming product inspections to final shipment verification, we maintain the highest standards of accuracy and reliability.
By adhering to ISO 13485, we help our partners mitigate risk, improve efficiency, and ensure patient safety.
Why ISO 13485 Matters for Your Business
✔ Minimized Risk: Reduces errors, recalls, and compliance issues.
✔ Enhanced Product Quality: Ensures reliable and accurate products.
✔ Increased Client Trust: Signals a commitment to excellence.
✔ Regulatory Confidence: Keeps you audit-ready with thorough documentation.
✔ Operational Excellence: Improves efficiency, accuracy, and fulfillment speed.
✔ Market Trust & Credibility: Builds credibility with stakeholders.
FDA-Registered Facility
Compliant & Reliable Healthcare Fulfillment
WellPact operates an FDA-registered facility, ensuring compliance with regulatory requirements for handling medical and healthcare-related products. Our adherence to Good Manufacturing Practices (GMP) and regulatory guidelines safeguards product integrity from storage to delivery.
As an FDA-registered facility, WellPact operates within strict regulatory guidelines to ensure compliance with medical and healthcare product handling requirements.
Our FDA registration provides assurance that your healthcare fulfillment operations are handled with the highest level of safety, accuracy, and compliance.
✔ Compliance with Good Manufacturing Practices (GMP)
✔ Proper storage, handling, and distribution of healthcare products
✔ Stringent environmental controls to protect product integrity
✔ Regulatory oversight to maintain compliance with healthcare standards
24/7 Surveillance:
High-resolution security cameras monitor all warehouse and operational areas.
Controlled Badge Access:
Only authorized personnel can enter secure areas, preventing unauthorized handling.
Visitor Management System:
All visitors must check in, receive authorization, and be escorted at all times.
Security Logs & Audit Trails:
Every access point is monitored and logged for traceability and compliance.
Facility Security & Controlled Access
Protection at Every Level
We understand that security extends beyond data—it’s about protecting every aspect of the fulfillment process, from inventory to shipment. These measures guarantee that every product, order, and piece of data is handled with the highest level of protection.
To maintain a secure fulfillment environment, WellPact enforces strict facility access controls, including:
Packaging & Shipping Services
Precision Shipping & Scalable Distribution
Our state-of-the-art fulfillment center is equipped with the latest automation and quality control technologies to optimize efficiency while maintaining the highest standards of accuracy and compliance. We handle custom packaging, labeling, and lot tracking, ensuring product integrity and security at every stage. With our integrated sample tracking solutions, we make it easy for healthcare companies to maintain compliance, reduce errors, and ensure patient safety.
Bulk Distribution
Custom Packaging
Direct-to-Patient and Provider Shipping
Eco-Friendly Materials
Real-Time Tracking & Visibility
Tamper-Evident &
Compliance Packaging
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Regulatory & Quality Compliance
WellPact's advanced fulfillment capabilities provide complete traceability of every component within a kit—ensuring the highest standards of safety and reliability for healthcare, diagnostics, and life sciences organizations.
HIPAA-Compliant Data Handling
Our systems and processes are designed to meet HIPAA privacy and security standards, protecting patient information at all levels.
Encrypted Systems
All data transmissions, records, and transactions are encrypted to prevent unauthorized access.
Access Controls
Only authorized personnel have access to sensitive patient and healthcare data.
Secure Data Handling Protocols
Our team follows strict guidelines to maintain compliance with healthcare privacy standards.
Secure Storage & Transmission
We implement strict security measures for handling and transmitting sensitive healthcare information.
Routine Security Audits
Regular testing and assessments ensure our systems remain secure against emerging threats.
Compliance with Healthcare Privacy Standards
We ensure that our partners’ data remains protected, confidential, and compliant.
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WellPact's advanced fulfillment capabilities provide complete traceability of every component within a kit—ensuring the highest standards of safety and reliability for healthcare, diagnostics, and life sciences organizations.
Quality Management
Precision, Consistency, and Compliance
At WellPact, we take a proactive approach to quality. Our Quality Management System (QMS) is designed to ensure accuracy, consistency, and compliance at every step of the
fulfillment process.
Quality is at the core of everything we do. Our robust Quality Management System (QMS) includes:
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Standardized operating procedures (SOPs) to maintain consistency
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Regular audits and performance monitoring to drive continuous improvement
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Documented training programs to uphold compliance at every level
At WellPact, quality is not an afterthought—it’s built into every process. Our comprehensive Quality Management System (QMS) ensures that every product, order, and shipment meets the highest standards.
Quality Management
Precision, Consistency, and Compliance
Standardized Processes
Every fulfillment step follows documented SOPs to maintain consistency.
Ongoing
Training
Our teams receive continuous education on compliance, quality control, and best practices.
Audits & Performance Monitoring
We regularly assess our processes, identifying areas for improvement to enhance efficiency and accuracy.
Corrective & Preventive Actions (CAPA)
If an issue arises, we take proactive measures to correct it and prevent recurrence.
Our Quality-First Approach
HIPAA Compliance & Data Security
Protecting Sensitive Healthcare Information
In healthcare fulfillment, data security is just as critical as product quality. WellPact is committed to HIPAA compliance, ensuring that all protected health information (PHI) is handled securely and in accordance with federal privacy regulations.
Our Approach to Data Security & Compliance
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✔ ISO13485-Certified Processes – Ensuring full regulatory compliance for healthcare logistics.
✔ Inventory Tracking & Automation – Providing full visibility and control over stock levels.
✔ Scalable Solutions for Growth – Supporting small-scale and high-volume fulfillment needs.
Why Choose WellPact for Medical Kit Assembly?
A: Yes! We tailor every kit to your specifications, sourcing components or integrating customer-supplied materials.
Q: Can you assemble fully customized medical kits?
A: Every kit undergoes multi-point quality checks, serialization tracking, and process validation to ensure accuracy.
Q: How do you ensure kit accuracy and completeness?
A: Yes! We offer scalable assembly solutions to meet both small-batch and high-volume production needs.
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Let’s Build the Perfect Medical Kits Together
From sourcing to final packaging, WellPact ensures your medical kits meet the highest standards of quality and compliance.