LIFE SCIENCES INDUSTRY
At Silver Bullet Security, we take pride in developing GxP compliant security solutions for the Life Science Industry. This is why we have worked closely with industry experts within the International Society for Pharmaceutical Engineering (ISPE) to develop and improve our solutions by aligning cyber security with their data integrity and computerized systems validations processes.
- Alignment of roles and responsibilities within the quality management system for IT, QA with relation to cyber security.
- Design the information security management model to be overseen by QA during the CSV process.
- Establish a governance framework to manage the creation and testing of cyber security requirements within the requirements specifications (URS, FS, CS/DS) and the qualifications testing (IQ, OQ, PQ) to meet data integrity requirements.
- Implement cyber security operations in line with best business practice and regulatory requirements for GxP environments.
- Integrate means for tracking, mitigating or accepting cyber security vulnerabilities for CAPA.
- Assist in creating matrix for treat modeling, data classification and systems criticality to determine appropriate levels of security for data and systems.
INDUSTRY SUPPORT AND ACTIVITIES
Asia Pacific GAMP Data Integrity Conference, 13-14 November 2017: Singapore
Data Integrity and Cyber Security by Jason Young CEO Silver Bullet Security.
2018 ISPE India Affiliate Annual Conference
Cyber Security and its Relationship to Data Integrity and Quality Risk Management by Jason Young CEO Silver Bullet Security.
2018 ISPE Annual Conference
Cyber Security Threats and Solutions, To Batch Record and Packing Line Serialization Data Integrity Requirements by Jason Young CEO Silver Bullet Security.