Arun Hp
About Arun Hp
Arun Hp is an Associate Engineer at ArisGlobal in Mysore, Karnataka, India, where he has worked since 2019. He specializes in compliance with ISPE GAMP5 guidelines and FDA regulations, and has experience in validation processes.
Work at ArisGlobal
Arun Hp has been employed at ArisGlobal since 2019, serving as an Associate Engineer in Mysore, Karnataka, India. In this role, he focuses on Computer System Validation (CSV), ensuring that systems meet regulatory compliance standards. His responsibilities include reviewing and closing Requests for Change (RFCs) using the MAGS tool, which is critical for maintaining system integrity post-implementation.
Education and Expertise
Arun Hp obtained a Bachelor of Engineering (BE) degree in Information Science/Studies from B. M. S. College of Engineering in 2008. His educational background provides a solid foundation for his current role in validation processes. He possesses expertise in reviewing compliance with ISPE GAMP5 guidelines, which is essential for ensuring that systems are validated according to industry standards.
Compliance and Regulatory Knowledge
Arun Hp is responsible for ensuring compliance with FDA 21 CFR Part 11 and EU Annex 11 regulations. His work is aimed at preventing non-conformities and observations during audits, which is crucial for maintaining the integrity of validation processes in regulated environments. His knowledge in this area supports the company's commitment to quality and regulatory adherence.
Validation Process Involvement
In his role, Arun Hp is actively involved in writing and revising templates for validation processes. This task is significant for standardizing documentation and ensuring that validation efforts meet both internal and external requirements. His contributions help streamline validation activities and enhance the overall efficiency of compliance efforts.