GxP Solutions

GxP Solutions

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:

  • 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.

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:

  • What is cyber security and how does it benefit QA?
  • Roles and responsibilities of cyber security
  • Cyber security functions for data integrity
  • User Requirements Specification (URS), Functional Specifications (FS) and Configuration/Design Specification (CS/DS) requirements and cyber security
  • Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) testing and cyber security
  • Reviewing and approving cyber security
  • Risk acceptance and evaluation
  • Incident response and CAPA

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:

  • Unauthorized access or failed attempts to access GxP regulated systems or data
  • Reporting for user accounts and permissions tracking
  • Permissions changes or violations to GxP regulated data or file structures
  • Change management monitoring and alerting for systems and data
  • Automated methods for CAPA tracking of cyber security vulnerabilities
  • Data manipulations or exfiltration
  • Alerts for vulnerabilities that impact data integrity

Industry Support and Activities

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 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.

Contact training@silverbulletsecurity.com to get a copy of any of our presentations