Elevate Compliance with RxCloud’s GxP Audit Services
The world of pharmaceuticals and life sciences is rapidly evolving. That means staying ahead isn’t just about meeting regulatory requirements. It’s about exceeding them.
At RxCloud, we help organizations elevate their business, products, and operations with our extensive GxP Audits. Our skilled Auditors not only ensure compliance but also help lay a foundation for future growth and innovation. Our GxP audit services are designed to inspire growth, streamline processes, and drive excellence across every facet of your operations.
Global Impact, Local Expertise
- Our GxP audit services transcend borders with a global presence of over 200 auditors operating across 27+ countries. Backed by an international team, we ensure seamless compliance with global standards such as ISO 9001:2015 and Italian DM 15-11-2011.
- Having established strong footholds in LATAM, the US, Africa, the EU, Canada, and Asia, we tailor our audit services to meet the unique needs of industries across these regions.
- To date, we have successfully completed more than 500 audits worldwide, continuously driving quality and compliance across diverse markets.
- We offer the perfect blend of global reach and local expertise. Whether it's GMP, GCP, GLP, GVP, or Security and Risk Management audits, our expert team ensures your organization is not only compliant but also future-ready.
Good Manufacturing Practice (GMP) Audits
At RxCloud, our GMP auditors dive deep into every aspect of your manufacturing operations to ensure your company & products adhere to all the regulatory requirements. With pre-written questionnaires and a comprehensive deviation database, we provide thorough audits that guarantee your processes, facilities, and products meet the highest standards of quality and safety.
Our GMP Audit covers:
• Quality Management Systems (QMS)
• Facility and Equipment Audits
• Personnel Qualification
• Raw Materials and Components
• Production Processes
• Packaging and Labeling
• Laboratory Controls
• Documentation and Record Keeping
• Complaint Handling and Product Recalls
• Validation and Qualification
• Regulatory Compliance
Good Laboratory Practice (GLP) Audits
Pharmaceutical and Life Science businesses cannot compromise on data integrity in their laboratory practices. RxCloud’s GLP audits lay the foundation of trust, ensuring your non-clinical studies adhere to the highest standards and eliminating data integrity issues for smoother regulatory approvals.
Key areas assessed during our GLP audits
• Laboratory Operations
• Standard Operating Procedures (SOPs)
• Facilities and Equipment
• Quality Assurance Protocols
• Test and Reference Substances
• Data Recording and Reporting
Good Clinical Practice (GCP) Audits
At RxCloud, we understand that Clinical Trials are the backbone of innovation in life sciences. That is why our GCP audits ensure that your trials not only meet but exceed global standards. We enhance the quality, efficacy, integrity, reliability, and compliance of your trials to help you pioneer innovations that ensure patient safety while also withstanding the test of time & scrutiny.
Our GCP Audit coverage includes:
• Protocol Adherence
• Informed Consent Processes
• Investigational Product Handling
• Adverse Event Reporting
• Data Management
• Monitoring Procedures
Good Pharmacovigilance Practice (GVP) Audits
Patient safety isn’t just a regulatory requirement. It’s a moral imperative. RxCloud’s GVP audits are designed to ensure your pharmacovigilance systems lead the industry in safeguarding patients.
Key areas covered in GVP Audits:
• Adverse Event Reporting
• Signal Detection
• Risk Management Plans (RMPs)
• QMS for Pharmacovigilance
• Case Processing and Safety Reports
• PV System Master File
• PV Agreements
Medical Device Audits
When it comes to Medical Devices, every detail can impact lives. Hence, maintaining impeccable quality, safety and compliance in medical devices is essential. RxCloud’s Medical Device Audit Services ensure that every medical innovation meets the highest standards, from design controls to post-market surveillance.
Our Medical Device Audit covers:
• Quality Management System (QMS)
• Design Controls
• Document Control
• Supplier Management
• Production and Process Controls
Security & Risk Audits
Innovation thrives in a secure environment. Our Security and Risk Audits are designed to safeguard your business against evolving kinds of cyber threats. Our comprehensive audits go beyond regulatory compliance, encompassing information security, risk management, and operational resilience. This ensures robust protection for your business, no matter the industry or region.
Our Security & Risk Audit Includes:
- Cyber Risk & Compliance Services: Ensuring compliance with global standards such as ISO 27001, ISO 22301, and PCI DSS, while providing advisory services for PCI P2PE.
- Vulnerability Assessments & Third-Party Security Risk Management: Utilizing tools like OneTrust, Archer, and ServiceNow GRC to enhance your security posture.
- Compliance with Data Protection Regulations: Assisting with frameworks like EU-GDPR, CCPA, and HIPAA, ensuring your business aligns with global privacy standards.
- Federal Government & Regulatory Compliance Services: Covering critical regulations like GLBA, HIPAA, SOX, FedRAMP, and FISMA.
- Data Privacy & IIOT Cybersecurity Blueprints: Offering insights into device and network security, preventive controls, and continuous monitoring to ensure your operation functions as intended.
Contact us today to get started.
Secure your compliance and quality excellence with RxCloud’s GxP audit expertise.