PHARMA, BIOTECH &
Organizations, which are active in the domain of Pharma – Biotech – Healthcare, are all required to implement a compliant and consistent risk-based Quality System. The prevention and the rational estimation of the risk of contamination is always a strong requirement of the applicable GMP regulation. In Kernelis, we do have an extensive expertise and experience with these regulatory systems.
The technology gives the means to rationally demonstrate the control and the compliance of the Organization for the following topics: Risk Management, Knowledge Management, Quality System, Data Integrity, Prevention of Cross-Contamination, Risk Exposure, Cleaning Validation, Design and Qualification of production Infrastructure, premises and equipment.
Since the computerized systems of Kernelis were designed to be fully validated in compliance with GMP requirements, this technology will provide the Client with the highly valued merit ofbeing accepted by Competent Bodies.
Risk, Resilience & Reinforcement
Automated Text Analysis, Linguistic Integration
Encryption, Document Authentication, Integrity Controller
Computational Evaluation of the Toxicity & Properties of Chemical Substance
Exposure Risk Assessment, Thermal Balance Evaluation
Automated Scan-to-CAD Processing
Explosion & Propagation Modeling
SOFTWARE SECTORAL APPLICABILITY (in %)
K-Resilience is by design perfectly adapted to control Risk and Resilience issues in the sector of GMP regulated activities. The Software has already been presented and even reviewed during formal inspections by Competent Bodies of Kernelis Client. To demo the performance of the Software in this domain, Kernelis has developed a specific case study.
With K-Descriptor used as a complementary standalone software, Kernelis has experience of effective review of Quality Systems and of Documents Package in various languages; this can be highly helpful in situation of compliance audit or technical due diligence.
K-Chemical gives the rational means to assess the toxicity and the level of exposure to chemical substances. This determination is inter alia useful to set the limits for cleaning validation.
K-Exchange, K-Meshing & K-Propagation should be used to combine their specificities to assess the performance of the infrastructure. Potential situation of cross-contamination, with the rational determination of the Permitted Daily Exposure and the OEL/STEL values for operators, can thus be assessed.