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.
Enhance your global compliance and security with our proven "Audit-as-a-Service" offering. With operations across 27+ countries and over 1500 audits conducted, we provide speed, precision, and cost-efficiency. From GMP, GCP, GLP, GVP, medical device audits to Security (CSCA / CyberGRX / NIST) & ISO, our rigorous audit processes and checklists ensure the highest regulatory, compliance & security standards for you and your suppliers
Computer System Validation Services
Uncover seamless compliance solutions with RxCloud's bespoke CSV and CSA services, designed specifically for the life sciences sector. Our pre-built validation assets for popular SaaS/GxP platforms accelerate go-to-market and release cycle times, ensuring efficiency and compliance excellence.
Unlock the Full Potential of Your Systems with Expert Computer System Validation
At RxCloud, we offer comprehensive CSV / CSA services that include:
Computer System Validation
Detailed validation of computer systems to comply with standards such as 21 CFR Part 11, Annex 11, ASTM E2500, and ISO 9001:2015.
Pharmaceutical Validation
Tailored solutions for the pharmaceutical industry to ensure data integrity and system reliability.
GxP Systems Validation
Expertise in validating systems under Good Practice (GxP) guidelines to ensure adherence to industry regulations.
At RxCloud, we offer Validation services that best suites the requirement of our global customers:
Validation-as-a-Service (VaaS)
RxCloud's Validation-as-a-Service (VaaS) provides a scalable, end-to-end validation operating model for GxP-regulated organizations. Acting as an extension of Quality, Compliance, and IT teams, we manage validation activities throughout the system lifecycle, helping customers maintain compliance while reducing operational overhead.
New System Validation
- Validation of newly implemented applications, platforms, infrastructure, and automated processes.
- Preparation and execution of validation plans, risk assessments, test protocols, traceability matrices, and validation reports.
Periodic Review and Revalidation
- Scheduled assessments and periodic validation reviews to ensure systems remain compliant, controlled, and fit for purpose.
- Evaluation of system performance, risks, deviations, and compliance status.
Change Validation
- Impact assessments and validation support for system upgrades, patches, configuration changes, migrations, and enhancement projects.
- Validation activities integrated into change management processes.
Regulatory and Compliance Validation
- Support for GxP, CSV, CSA, data integrity, and applicable regulatory requirements.
- Validation documentation aligned with industry best practices and organizational standards.
Managed Validation Operations
- Ongoing management of validation artifacts, validation inventories, SOP adherence, audit readiness, and compliance reporting.
- Scalable validation resources available on demand.
Validation services for a specific project / Program
Qualified and Experienced Validation resources to join your team to achieve the specific outcome within time and budgets.
GxP SaaS Application Services
RxCloud offers comprehensive GxP-compliant SaaS application services for compliance and operational excellence. With RxCloud's E2E managed services constituting advanced processes, test/validation assets, and automation solution, ensure seamless GxP compliance of your SaaS platforms for regulatory and operational success.
RxCloud is proud to be acknowledged as an expert service provider of the eQMS solutions including OneQMS from Astakenis, SAP, Serialization, and other end-to-end solutions for life sciences. We have 100+ qualified and certified techno-functional experts, providing upgrade, maintenance, and support services to help customers deliver value and speed to their business. We assure seamless development, enhancement, and validation support with our quality experts in the USA, Canada, UK, Europe, and India.
Quality Engineering Services
Discover our comprehensive Quality Engineering services that maximize efficiency and accelerate time to market with cost-effective "As-a-Service" offerings. We cover test automation, performance, security, usability/accessibility, and offer compliance-focused solutions with zero CAPEX and low OPEX. Count on us for the full spectrum of QA services, including content and SOP authoring.
RxCloud’s QA Consulting services are designed to elevate your operations, ensuring that your processes, systems, and documentation meet the highest industry standards. Our QA consulting services cover:
SOP Development and Management
We help create, review, and optimize Standard Operating Procedures (SOPs) to ensure compliance and improve operational efficiency.
Process Optimization
We offer consulting services tailored to your needs, identifying areas for improvement and providing solutions to enhance your overall processes.
Audit Preparedness
We ensure that your processes and SOPs are properly structured, giving you the confidence that you’re well-prepared for any future assessments or evaluations.
Our services are tailored to meet the unique demands of regulated industries like life sciences, ensuring that your QMS is optimized for both performance and compliance with industry standards. Our Quality Management System (QMS) Services cover:
Implementation
Expert end-to-end setup and implementation of QMS platforms like OneQMS, tailored to your specific needs for optimal performance and compliance.
Migration
Seamless transfer your QMS data from legacy systems to advanced platforms. We ensure data integrity, minimal downtime, and a smooth transition, reducing any operational disruptions.
Upgrades
Upgrading your QMS to keep pace with evolving regulations and industry standards, enhancing functionality and compliance.
Validation
Thorough QMS validation services, adhering to GxP, FDA, and ISO guidelines. Our validation processes ensure that your system functions as intended, is fully compliant, and meets quality and regulatory standards throughout its lifecycle.
RxCloud Accelerators, AI Enabled Integrated Solutions
RxAuditor
RxAuditor stands out as the premier choice for navigating audits, favored by global organizations in regulated industries such as pharmaceuticals, CROs, and medical devices. Forget about cumbersome audit scheduling—RxAuditor simplifies operations and offers customizable solutions, providing unmatched insights and visibility into your audit processes. It covers GxP (GMP, GCP, GLP, GVP, SaaS) audits (both internal & external), spanning manufacturing, clinical, laboratory, and safety vendor services.
RxSmarTest
RxSmarTest revolutionizes the testing lifecycle by reducing testing times and accelerating product launches through several
Pre-built automation test sources cover various COTS products, reducing test design efforts by up to 50%.
Key features:
- Scalable framework automates large regression suites, saving execution efforts by up to 70%.
- Pre-existing framework for test automation and one-click execution of test suites
- Comprehensive HTML and PDF reporting streamline validation efforts, saving re-execution time.
- Cloud-based platform offers a pay-as-you-go model
- Automation-driven approach leading to reduced human dependency
- Intuitive interface and centralized data management system
RxSmarTest delivers faster go-to-market solutions and regulatory standards-driven testing, making it a comprehensive solution for efficient and compliant test management.
RxQCAgent
RxQCAgent is RxCloud's AI document review accelerator — a quality gate purpose-built for controlled documents in the life sciences industry. It intercepts each document as it enters the review workflow, automatically checks it for review-readiness, and routes the outcome: only review-ready documents move forward, while the rest return instantly with clear, reason-coded findings. This intelligent document review process reduces rework, shortens review cycles, and keeps your quality team fully in control — with every decision backed by an audit-ready trail. RxQCAgent works across SOPs, work instructions, validation records, and regulatory and quality documents, complementing your existing Quality Engineering services and QMS.
rKive
rKive - Retire legacy systems with confidence. RxCloud’s proprietary framework, rKive, empowers Life Sciences organizations to securely decommission outdated applications and archive regulated data—while maintaining full compliance, audit readiness, and long-term instant data accessibility.
Application Decommissioning Strategy & Roadmap
Whether you’re sunsetting redundant applications post-SAP or Veeva deployments or rationalizing your Clinical & Manufacturing IT landscape for cloud transformation, our specialized rKive framework ensure 100 % compliance and zero deviations. We bring automation, validation, and governance together to preserve data integrity across clinical, regulatory, and quality domains.
RxCloud’s Decommissioning & Archival Service Spectrum Includes:
- Legacy System Rationalization & Impact Analysis
- Secure Data Extraction & Archival
- Archival System Design & Implementation
- Validation Documentation & Compliance Frameworks
- Data Retention & Governance Policy Alignment
- Audit-Ready Metadata Cataloguing & Reporting