Pharmaceutical and GxP Regulated Industry Solutions
At Silver Bullet Security, we take pride in developing solutions for the Life Science Industry to meet the complex range of regulatory requirements for compliance. This is why we have worked closely with industry experts like the International Society for Pharmaceutical Engineering to develop and improve our solutions aligning cyber security with their data integrity and validations processes.
Computerized Systems Validation Support for GxP Environments
Knowing how cyber security is used to apply data integrity to your CSV process for GxP computerized systems and data is key proper risk management. We specialize in integrating Information Security Management best business practices within the governance structure of your Quality Management System for FDA, EU, PIC/S or ICH regulated environments according to COBIT 5 or ISO 27001 standards. Examples of the areas we provide support in:
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.
Industry Support and Activities
24x7 Data Integrity Monitoring
Along with our standard gold, silver and bronze monitoring solutions, we also have data integrity monitoring and logging for GxP regulated processes. This allows you to meet all regulated requirements withing your environment with regards to data integrity monitoring for items like:
Cyber Security and GxP Training
Our GAMP 5 and Cyber Security for Quality Assurance Professionals training course is specifically designed to teach non-technical quality assurance professionals how to use cyber security within their QMS. Some of the areas of training include:
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.
Asia Pacific GAMP Data Integrity Conference 13-14 Nov 2017 Singapore: Data Integrity and Cyber Security 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.
Contact email@example.com to get a copy of any of our presentations