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Our comprehensive team of highly experience compliance experts helps ensure the integrity, security, and reliability of your information systems. With a focus on Computer Systems Validation (CSV), we ensure your software meets regulatory standards and delivers precise results. Leveraging extensive experience, we conduct thorough testing, documentation, and validation to confirm that computerized systems consistently meet requirements and comply with regulations, safeguarding data integrity and patient well-being.
Provide testing and validation services for computer systems used in regulated environments including pharmaceutical, biotechnology, medical devices, and healthcare industries. Our core offerings include Validation Planning, Risk Assessment and Mitigation, Requirements Gather and Documentation, System Configuration, and Installation (IQ), Operational Qualification (OQ), Data Integrity Assessment and Validation Documentation & Reporting.
In partnership with our clients, we will oversee the planning, execution and completion of projects aimed at validating computer systems used in regulatory environments. We have proven experience in Project Initiation, Resource Planning, Project Scheduling, Validation Planning, Risk Management, Execution and Monitoring, Communication and Stakeholder Engagement and Change Management.
Pharmacovigilance services to ensure the safety and efficacy of pharmaceutical products throughout their lifecycle. We specialize in drug safety and pharmacovigilance (DSPV) systems process implementation and re-engineering. Our core offerings include, Adverse Event Reporting, Case Processing & Management, Signal Detection & Risk Management, Aggregate Safety Reporting, Regulatory Compliance, Risk Management Plans (RMP’s), Literature Screening and Review, Safety Data Analysis & Evaluation, Pharmacovigilance Training & Education, and Quality Assurance & Auditing.
We provide Data Integrity Program services essential for ensuring the accuracy, reliability, and completeness of data generated and maintained within regulatory environments. Our core offerings include Policy Development, Risk Assessment & Gap Analysis, Training & Education, Data Governance Framework, Data Lifecycle Management, System Validation & Controls, Data Quality Monitoring & Metrics and Auding & Compliance.
Moving to the cloud offers numerous benefits: lowered capital and operating expenses due to decreased hardware and staff requirements, reduced opportunity costs with monthly fees replacing large expenditures, increased agility, and improved availability and reliability. We aid organizations in the seamless transition of their IT infrastructure, applications, and data from onpremises environments to cloud-based platforms. These services encompass assessment, planning, implementation, and optimization phases to ensure a smooth migration process while minimizing disruption to business operations.
Expertise in selecting the appropriate cloud architecture, addressing security considerations, optimizing performance, and maximizing cost efficiency, tailored to the specific needs and goals of each client. Accelerate cloud adoption by implementing cloud best practices that streamline operations and reduce costs.
Streamline the management of your cloud applications and services while also focusing on continuous governance and compliance enforcement.
Automate repetitive tasks and workflows to increase operational efficiency, reduce human errors, and allow employees to focus on more value-adding activities
Harnessing artificial intelligence and machine learning is pivotal for businesses to thrive. Our AI and ML services empower you to make data-driven decisions, automate processes, and foster innovation. With our consulting and solutions, you gain invaluable insights, strengthen customer relationships, and seize new revenue opportunities. We integrate data visualizations, business analytics, AI, ML, deep learning, and unified data platforms to transform your data into actionable insights. This holistic approach ensures your business stays ahead in dynamic markets, adapts to changing customer demands, and maximizes the potential of your data, driving sustainable growth and competitive advantage. Unlock the power of your data assets via Analytics, AI and ML with us today.
We provide end-to-end data management and governance through innovative tools to deliver responsive, accurate data services that strengthen your insights and operations. We establish policies, processes, and controls to ensure data quality, security, and compliance.
Utilize a robust data architecture that integrates data from diverse sources and enables analytics to uncover insights through descriptive, diagnostic, predictive, and prescriptive techniques.
Implement solutions that utilizes machine learning and artificial intelligence techniques to streamline processes, identify patterns, and generate predictive insights
Streamlines the deployment, management, and scaling of machine learning models in production environments by automating workflows, monitoring model performance, and ensuring model reliability and scalability to drive successful machine learning deployments.
Engage our experts and unlock the next level of technological growth for your company
Leverage our experts as a strategic partner to provide leading compliance, digital transformation and Big Data services and solutions