In the Life Sciences industry, mistakes can be costly. Even deadly. To ensure your organization is meeting all compliance requirements, simply count on Syntax.
Syntax is an industry expert in computer validation regulations governing life science and managed SAP hosting infrastructure for installation qualification (IQ).
Our audited quality management (QM) system is designed to provide you with assurance and peace of mind for enhanced control and record keeping of your outsourced application services.
A Risk-Based Approach to FDA Compliance
When it comes to FDA compliance, avoiding risks is a reward in and of itself. That‘s why Syntax uses a risk-based approach to support FDA compliance for Life Science companies.
We Can Help You:
- Evaluate overall system risk to product quality, patient safety and data integrity (GAMP5)
- Develop a comprehensive set of functional requirements for your systems
- Perform methodical risk analysis on defined requirements
- Categorize risk based on potential consequences if the function does not work properly
- Prepare test verifications (qualifications) that are scaled to the risk level assigned to the function tested
- Collaborate with you and your vendors on compliance efforts according to established roles and responsibilities (use and administration)