Assured Adeptness, Accuracy, and Adherence in Every Audit
Simplify complex auditing procedures and ensure strict compliance every step of the way
Explore RxCloud's Global Audit Capabilities
200+ auditors, 5+ engagements, 300+ audits, 22 countries. At RxCloud, we offer premier Audit Services, ensuring ISO 9001:2015 and Italian DM 15-11-2011 compliance. Our multilingual support extends across LATAM, the US, Africa, the EU, Canada, and Asia for thorough GVP, GMP, GLP, GCP, and security audits. Our pre-defined audit questionnaires address your pain points, our efficient Audit Management System ensures precise, timely audits while our deviation database aids future audits.
Good Manufacturing Practice (GMP) Audits
We bring in the power of our deep-rooted expertise in auditing manufacturing process, equipment, operations and facilities with our pre-written questionnaire and deviations database which makes our GMP audits compliant and efficient.
Our GMP audit covers:
• QMS
• Facility and Equipment
• Personnel
• Raw Materials and Components
• Production Processes
• Packaging and Labelling
• Laboratory Controls
• Documentation and Record Keeping
• Complaint Handling and Product Recall
• Validation and Qualification
• Regulatory Compliance
Good Laboratory Practice (GLP) Audits
With our GLP audits, we aim to eliminate data integrity issues, provide suggestions to improve the reliability of study results and facilitate the acceptance of data for regulatory purposes.
Our auditors evaluate:
• Laboratory Operations
• Standard Operating Procedures
• Facilities
• Quality assurance protocols
Enhance Clinical Trial Credibility with RxCloud's GCP Audit Services
Our GCP Audit Services will help you improve the credibility of clinical trial data submitted for NDA approval and get through it the very first time.
• Protocol adherence
• Informed consent processes
• Investigational product handling
• Adverse event reporting
• Data management
• Monitoring procedures
Evaluating Pharmacovigilance Systems and Ensuring Compliance with GVP Audits
GVP audits are conducted to examine compliance with Good Pharmacovigilance Practice (GVP) guidelines. Our audit specialists will analyze the pharmacovigilance systems and processes implemented by your pharmaceutical company to monitor and manage the safety of their products.
Our auditors evaluate:
• Adverse event reporting
• Signal detection
• Risk Management Plans
• QMS
• Case Processing
• Aggregate Safety Reports
• PV System Master File
• PV agreements
Medical Device Audits
Ensure the highest standards of quality and compliance with our comprehensive medical device Audit Services. Our expert team conducts thorough assessments across all critical areas of your medical device operations, from design controls to post-market surveillance. Trust us to safeguard your reputation and enhance patient safety through rigorous and reliable medical device audits.
Our auditors evaluate:
• QMS
• Design Controls
• Risk Management
• Document Control
• Supplier Management
• Production and Process Controls
Security & Risk Audits
With our Security and Risk audits, we evaluate the robustness of safety measures and risk management protocols implemented within pharmaceutical, biotechnology, and medical device companies. Our Security and Risk audits are tailored to address the unique challenges and complexities, including vulnerability checks, hurdles with implementing security protocols, and managing third-party security risks.
Considering the sensitive nature of patient data, maintaining confidentiality in research and development is paramount. With the rise in cyberattacks and data breaches, robust security measures are needed. We conduct a detailed analysis of your organization’s protective measures and detect threats early. Our assessment of third-party risks will help you become compliant with data protection and privacy regulations.
Creating Values
Customer Testimonials
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Knowledge Repository
Explore our collection of in-depth case studies and white papers to discover how RxCloud is reshaping the industry.
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Accelerating Innovation in Life Sciences: How the Veeva AI Partner Program is Unlocking the Power of GenAI
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