A Partner You Can Trust
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.
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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.
Quality Management
Precision, Consistency, and Compliance
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.
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.
Compliant & Reliable Healthcare Fulfillment
FDA-Registered Facility
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.
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Compliance with Good Manufacturing Practices (GMP)
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Proper storage, handling, and distribution of healthcare products
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Stringent environmental controls to protect product integrity
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Regulatory oversight to maintain compliance with healthcare standards
Meeting the Highest Standards in Healthcare Fulfillment
ISO 13485 Certified
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
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.
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.
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:
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.
Protecting Sensitive Healthcare Information
HIPAA Compliance & Data Security
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.
HIPAA- Compliant Data Handling
Secure Data Handling Protocols
Encrypted Systems
Secure Storage & Transmission
Access Controls
Compliance with Healthcare Privacy Standards
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Rigorous Standards for Healthcare Compliance
We maintain the highest standards of quality management throughout the procurement process. Every material sourced is thoroughly vetted and inspected to ensure it meets regulatory requirements and quality benchmarks.
Compliance Assurance
All materials are compliant with FDA, ISO, and HIPAA regulations, guaranteeing safety and quality.
Quality Control Checks
Every component undergoes rigorous testing before it is approved for use in your kits, ensuring consistency and reliability.
Full Tracking & Traceability
Our tracking systems ensure that each material sourced is fully traceable, providing transparency and accountability.
ISO13485-Certified Processes – Ensuring full regulatory compliance for healthcare logistics.
Integrated Sample Tracking & Return Logistics – Full traceability for compliance and security.
Seamless Direct-to-Patient Fulfillment – Reliable and secure shipping to patients and providers.
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Why Choose WellPact for Fulfillment & Logistics?