C-realize IT Governance for secure and compliant cloud computing

The C-realize IT Governance and Compliance service stream enables pharma and life sciences clients to embed the robust quality and information security management systems that have become key requirements for ISO Standard and other quality certification in a virtualized environment.

The service includes ongoing management and support, recognizing that information security compliance is not achieved through one-time computer systems validation but is a continuous process of control that requires robust and agile IT management systems.

Data Governance

With recent virtualization and digitalization trends, and emerging information threats, IT governance and compliance has become a pressing priority on multiple levels for the life sciences industry.

Organisations face a mounting range of regulatory requirements in IT including data integrity and protection, operational and financial risk management. Therefore, IT governance and compliance has become an executive level issue.

The overall aim in IT governance is to meet the requirements of ISO 27001, ITIL®, COBIT , NIST, CIS, SOC, and other standards, which all define best-practice approaches to IT governance regulatory compliance.  A fully functional information security management system (ISMS), links all the IT-related regulations and includes structured guidance for a risk-based approach to securing the integrity, confidentiality, and availability of corporate data. It also defines an overall management framework that creates an environment with specific internal controls.

Cloud Compliance

Ensuring full IT compliance entails establishing a coordinated, integrated framework that draws on all principal standards.

The C-realize IT Governance and Compliance solution can easily be combined with its proprietary digital Quality Management System and software development lifecycle based on GAMP protocols but can also be tailored to any organizational setting. The OpenQMS.net application is available as a lightweight, cloud-native and scalable end-to-end Quality Management System software solution that can easily be deployed as stand-alone on-site installation or delivered as a hosted app.

This open source and free-to-download application is designed and built to meet biopharmaceutical quality standards such as GXP, FDA Part 11, and EMA Annex 11. Based on Microsoft’s .NET framework, OpenQMS.net can easily be integrated with Office365, Azure cloud and other Microsoft technologies.

This provides a shared framework for compliance monitoring and management of a range of IT regulations and standards, with a system that can be scaled up across a functionally and geographically diverse business. Use of a central cloud-based data platform and web-based interfaces supports easier consolidation and multi-cloud systems integration along with automation and streamlined compliance management workflows.

In-depth expertise

C-realize combines hands-on experience in modern agile software development and the latest cloud technologies with quality and regulatory compliance expertise dealing with QA managers at various world-leading life science companies as well as institutional auditors.

Founder and CEO Hao Wang, who leads every project, has more than 15 years’ experience in quality and regulatory compliance serving various Big Pharma companies as well as a range of SMEs in the life sciences industry.

The C-realize IT Governance and Compliance service is characterized by its pragmatic approach, delivery to the promise, competitive pricing and cost efficiency combined with a quality driven focus on added value and active support.

The service enables life science companies to increase brand and stakeholder values by reinforcing trust among customers and regulatory authorities, meeting quality and compliance requirements allowing for increased data integrity and accessibility and faster exchange of information, increasing competitiveness through streamlined, automated, paperless processes.

Resources

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C-realize provide help and support for all your Pharma, Biotech and Medical Devices needs in software development, cloud computing services and regulatory compliance advice and solutions, to learn more please book in a Introductory Consultation Session.