EXPERT SYSTEMS FOR
GOVERNANCE, RISK & COMPLIANCE
Providing means to a rational and effective management of risk and resilience through innovative computational methods
Pharma, Biotech, Cosmetics & Medical Devices
Companies active in the sectors of pharmaceuticals, biotechnology, cosmetics, and medical devices must implement a compliant and consistent risk-based quality system. The prevention and rational estimation of risk is always a strong requirement of the applicable regulatory standards. At Kernelis, we have extensive expertise and knowledge of regulatory systems.
Kernelis technology provides the tools to assess the organization’s control and compliance in the following critical business functions: Risk Management, Knowledge Management, Quality System, Data Integrity, Cross-Contamination Prevention, Risk Exposure, Cleaning Validation, Design and Qualification of Production Infrastructure, Premises and Equipment.
Our computerized systems are designed for full validation in compliance with GMP requirements and have proven their effectiveness in numerous projects. This technology will offer you the valuable distinction of being successfully accepted at inspections by Competent Bodies.
Numerical modeling systems to address multiple aspects of risk exposure
Our technology is composed of both modeling systems and a series of dedicated databases, that are continuously maintained for seamless integration. Each module can operate as a standalone application or can be combined with the other modules of the suite to assess a global risk and resilience configuration.
Among the software suite, Kernelis provides a disruptive concept in Risk, Resilience & Compliance Management with INISCIENT*.
*INISCIENT was formerly named Kernelis Resilience.
Evaluation of organizational compliance
Are you going to be audited for your compliance with regulatory standards? Do you have subsidiaries, partner organizations, or suppliers and want to audit them against certain regulatory standards?
Iniscient is the reference tool:
For quality assurance departments, it meets the day-to-day needs of healthcare companies while sparing resources.
For audit teams, it ensures regulatory conformity assessment of remote organizations, even during severe disruptions such as travel shutdowns.
Optimization of organizational compliance
For leaders who care about the performance of their organization. Iniscient provides the essential keys to strengthen the organization according to its own priorities.
INISCIENT Manager proposes an action plan for the continuous improvement of the Quality Management System that complies with set objectives and existing organizational resources.
Secure, online, up-to-date
INISCIENT runs on Microsoft Azure as a SaaS [Software as a Service] to provide robust data protection while offering worldwide access and continuously updated status.
As a manager of an organization, your company’s data, calculations, results, and reports are kept in a private storage area, securely isolated from other clients. The organizational documentation is hosted in a virtual data room (VDR) of your choice, where you have full control over when and how Iniscient can access it.
As an advisor to multiple organizations, INISCIENT gives you access to all the organizations you track on the same web page while ensuring data confidentiality (each organization’s data are isolated from the others in a dedicated, and protected storage).
Each organization has full control over the virtual data room (VDR) containing the organizational documentation and decides on the access levels of its consultant and Iniscient.
Contact us for more info or technical details: email@example.com
Kernelis Innovation SA
Kernelis Innovation SA provides all technological services, systems, and know-how necessary or useful for the development and maintenance of Kernelis technology.
Biolleyre 5, 1066 Epalinges, Switzerland
Kernelis Europe SAS
Kernelis Europe SAS acts as a Marketing and Sales Company of Kernelis technology.
17 rue du Lac Saint André, BP 30240, 73374 Le Bourget-du-Lac Cedex, France
To enhance the provision of services and improve the capabilities in the domain of IT, Kernelis has partnered with ELCA.