OpenNovations is an independent consultancy company, renowned for its ability to bridge the gap between ICT solutions and business processes within the highly regulated pharmaceutical, healthcare, and medical sectors. Our goal is to leverage cutting-edge ICT to improve operational effectiveness, data integrity, and regulatory compliance across all operational dimensions.

Whether it's enhancing safety protocols, navigating regulatory compliance, or implementing Quality Management Systems and Standard Operating Procedures, OpenNovations' goal is to empower organizations to not just meet, but exceed standards.
OpenNovations differentiates itself through a unique blend of ICT and business process expertise, supported by our active collaboration with standardization bodies and regulatory agencies.

Our areas of expertise are broad, yet deeply specialized, covering compliance and validation within GxP, GAMP5, GDPR, FDA CFR 21 Part 11, and NEN7510. We are proficient in conducting comprehensive security audits, risk management, and consulting, following best practices aligned with ISO 27001, NEN7510, NCSC, ENISA, ENISA, OWASP, and OSSTMM standards.

The core of our technology offering is Aranei, a web-based business process information management system that has revolutionized the way businesses handle data management and processing. Aranei provides a pathway for companies to transition from outdated systems to a modern, web-standard-based environment. This platform demonstrates our commitment to full data control and accessibility, as well as to elevating data privacy and security standards.

 

Availability for Work

Europe, North America, Australasia, Remote, Asia

Areas of Expertise

Auditing,Information Technology (IT), Medical Devices, Quality Management Systems (QMS), Quality Risk Management (QRM), Standard Operating Procedures (SOPs), Inspection Preparation

Contact Details

Hans de Raad

Telephone: +31 6 83578847

Email: info@opennovations.nl

Website: https://www.opennovations.eu

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