PHARMACEUTICAL, BIOTECH, COSMETICS & MEDICAL DEVICES

AD_Kernelis_Resilience.png
AD_Kernelis_Propagate.png
AD_Kernelis_Meshing.png
AD_Kernelis_Chemical.png
AD_Kernelis_Exchange.png
AD_Kernelis_Resilience.png
AD_Kernelis_Resilience.png
AD_Kernelis_Resilience.png
AD_Kernelis_Resilience.png
AD_Kernelis_Chemical.png
AD_Kernelis_Exchange.png
AD_Kernelis_Resilience.png
AD_Kernelis_Chemical.png
AD_Kernelis_Exchange.png
AD_Kernelis_Resilience.png
AD_Kernelis_Propagate.png
AD_Kernelis_Exchange.png
AD_Kernelis_Propagate.png
AD_Kernelis_Exchange.png
AD_Kernelis_Meshing.png
AD_Kernelis_Encrypt.png
AD_Kernelis_Resilience.png
AD_Kernelis_Encrypt.png
AD_Kernelis_Resilience.png

Organizations, which are active in the domain of Pharma, Biotech, Cosmetics & Medical Devices, 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 of being accepted by Competent Bodies.

To achieve this transversal activity, the pieces of the technology and among them Kernelis Resilience fully comply with the requirements of general normative standards such as:

AD_Kernelis_Resilience.png

Examples of GENERAL references integrated

  • ISO 9001 (Quality Management)

  • ISO 22313 (Business Continuity)

  • ISO 26000 (Social Responsability)

  • ISO 31000 (Risk Management)

  • ISO 45001 (Occupational Health and Safety Management)

  • ISO 50001 (Energy Management)

  • ISO 55000 (Asset Management)

  • ANSI / ASIS PAP.A (Physical Asset Protection)

  • ASIS SPC.1 (Security, Preparedness, and Continuity Management)

  • ASIS/SHRM WVPI.1 (Workplace Violence Prevention and Intervention)

  • etc.

Examples of DOMAIN-SPECIFIC references integrated

  • EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use

  • 21 CFR p210 – 211

  • PIC/S and ICH Guidelines

  • ISO 14644: Cleanrooms and associated controlled environments

  • ISO 14698: Cleanrooms and associated controlled environments – Biocontamination control

  • ISO 16890: Air filters for general ventilation

  • NSF/ANSI 49: Biosafety Cabinetry: Design, Construction, Performance, and Field Certification

  • ISO 22716: Cosmetics Good Manufacturing Practices

  • Regulation (EC) 1223/2009

  • ISO 11930: Cosmetics — Microbiology — Evaluation of the antimicrobial protection of a cosmetic product

  • ISO 17516: Cosmetics — Microbiology — Microbiological limits

  • ISO 29621: Cosmetics — Microbiology — Guidelines for the risk assessment and identification of microbiologically low- risk products

  • 21 CFR p820

  • ISO 13485: Medical devices — Quality management systems

  • ISO 14971: Medical devices — Application of risk management to medical devices

  • ISO 11607: Packaging for terminally sterilized medical devices

  • EC Directives on Medical Devices

  • etc.

CRUCIAL

MODULES

AD_Kernelis_Resilience.png

Resilience

Risk, Resilience & Reinforcement

Kernelis 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 which can be watched upon request.

AD_Kernelis_Exchange.png
AD_Kernelis_Meshing.png
AD_Kernelis_Propagate.png

Exchange

Exposure Risk Assessment,

Thermal Balance Evaluation

Meshing

Automated Scan-to-CAD

Processing

Propagation

Explosion & Propagation

Modeling

Kernelis Exchange, Meshing & 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.

OF DOCUMENTATION SYSTEM

Kernelis Resilience

ICADS

AD_Kernelis_Resilience.png

Integrated Computational Analysis of Documentation System

Practical Implementation for an Audit Leading

Copyright © 2020 Kernelis. All rights reserved