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In the dynamic landscape of pharmaceuticals and healthcare, the role of AI and Cloud technologies has increasingly become an intrinsic part of daily operations, and along with that, the challenge of maintaining compliance.
Ensuring the latest AI and Cloud technologies comply with Good Practice (GxP) guidelines, specifically FDA 21 CFR Part 11 and EU GMP Annex 11, is crucial for companies to leverage the power and value of modern solutions including SaaS, PaaS, and IaaS, and Artificial Intelligence.
AI's integration in these sectors brings challenges in how to approach and maintain validation and compliance. iVigee’s validation services ensure that AI systems are reliable and safe, with a focus on meeting the regulatory standards, in both static and dynamic system scenarios.
We have the experience and expertise to navigate regulations and methodologies, fast-tracking your use of AI and systems to deliver their efficiencies with your pharmacovigilance processes.
That requires an advanced approach to how these technologies and their supporting systems are validated, adapting to and anticipating their specific differences and nuances as they themselves develop and advance, and regulatory requirements respond in parallel.
Validation Process.
Our AI and cloud-based systems validation process includes detailed validation planning, rigorous testing, and comprehensive documentation to guarantee precision and adherence to regulatory norms.
We ensure that validation extends to all supporting systems, like test management and data storage systems, providing an end-to-end validated ecosystem.
Data Management as an essential part of AI systems validation.
We proactively ensure the integrity and quality of data, including all necessary data management processes, which is vital requirement for robust AI model design.
We conduct a comprehensive review of data management practices to ensure unbiased and controlled data storage, adhering to the strictest privacy and confidentiality standards.
We continually monitor AI systems to assess and manage the level of uncertainty and ensure reliable results.
Compliance and Quality Assurance.
Quality assurance and regulatory compliance are our top priorities, and we continuously update our services and practices with the latest regulatory changes to ensure your AI and cloud-based solutions meet or exceed current industry standards.
Tailored Solutions.
We offer customised solutions that are aligned with each client's specific objectives, IT ecosystem, and regulatory requirements.
We are recognised as industry experts in understanding and working with regulations like FDA 21 CFR Part 11 and EU GMP Annex 11, and continuously enhance our knowledge alongside technological changes to ensure you meet compliance with confidence.
iVigee is a DIA and ISoP AI training partner, and our team is recognized by both leading industry organisations and regulatory authorities as a global expert in the validation requirements for these new technologies as they start to play a greater part in pharmacovigilance.
This enables us to ensure their implementation remains compliant while addressing your unique needs and challenges.
The pace of change with AI and new technolgy is unprecedented, with a constant stream of new developments and methods evolving that promise ever increasing abilities and efficiencies.
iVigee is at the forefront of this new technological era for pharmacovigilance, and so we too continuously evolve and improve our methods and processes alongside these advancements, allowing us to support your implementation of them faster, and in safety, giving you a competitive market advantage.
