Audits

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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 ​​

Auditing Experts in 22 Countries

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.

Our Team of GxP Audit Specialists

Zeinab El-Zein

GMP Lead Auditor | Lebanon

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Olga Korolkova

GMP Lead Auditor | Moscow | Russia

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Vanmeeganathan Balakrishnan

GxP SaaS, GMP Lead Auditor | Canada

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Creating Values

Customer Testimonials

Hear from our esteemed customers how our differentiated solutions & services delivered value

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“Our experience with RxCloud for Performance Engineering as a Service has been excellent. With custom executions targeting varied user bases and simulations of real user conditions across different geographies, their team ensured a seamless user experience. They greatly helped reduce our testing cycle times and capital expenditure costs. They have truly delivered outstanding results, driving efficiency in our operations.”

Director of Quality and Operations at a Leading CRO based out of North Carolina, USA

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“Utilizing RxCloud services to streamline our test cycles for Veeva Safety Docs has been transformative. They effectively removed dependency on resources and technical knowledge for test executions and ensured a remarkable 90% reduction in cycle times.”

Chief Information Officer at a Leading Pharmaceutical Company based out of California, USA

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“Our partnership with RxCloud for End-to-End Audit Services has been exceptional. Their team ensured timely audits, global coverage, and a 35% cost reduction with their Fixed Price Managed Services Model.”

Director of Quality and Compliance at a Leading CRO based out of North Carolina, USA

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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