Pharmaceutical & Biotechnology
As the FDA enforces a risk-based approach to cGMPs and 21 CFR Part 11, pharmaceutical and biotechnology companies need technology solutions that balance the need to innovate with the need to control. With years of experience in life sciences, GxP Partners understands the regulatory pressures and risk management challenges that you face. We also know the information technology requirements for efficient product development and manufacturing.
GxP Partners represents a number of forward-thinking software development companies with time-tested approaches to quality and content management. We help you build quality and compliance into your processes for managing:
- corrective and preventive actions
- complaint handling
- internal and external audits
- document control
- SOP enforcement
- employee certification and training
- instrument calibration
- supplier quality management
GxP Partners solutions help to foster innovation within your organization while maintaining a primary focus on safety, efficacy, and security. We've made it our business to navigate the requirements for GxP electronic records and signatures based on predicate rules, the nature of the process, and the quality and safety risks. We know how to apply security measures for both high-impact and low-impact records. Plus we know when and how the integrity of your business information can be protected through configuration management, system validation, change control, and security features.