We provide compliance through software validation
- GxP Experts
- Software Experience
- Comprehensive Approach
- Inadequate Documentation
- Lack of User Involvement
- Insufficient Planning
- Over-Reliance on Vendor Assuranes
- Excessive Costs
- Neglecting Risk Management
Validation Approach
Our validation approach meets all the requirements for:
Functionality
Usability
Reliability
Performance
Supportability
- EIS has over 30 years of experience on 900+ projects in varying roles. This has provided our staff with the ability to navigate any software development & implementation project through the sometimes difficult validation terrain.
Why choose Enhanced Information Solutions
- Create and approve validation strategy
- Leverage vendor testing & documentation
- Focus on business and process relevant tests
- Involve key users in end-to-end testing
- Integrate early with ERP and automation
- Dry runs and informal pre-tests minimize test deviations
- Treat ERBs as data not software if possible
Industries We Support
- Biotechnology
- Pharmaceutical
- Cell & Gene Therapy
- Medical Device
- Food and Beverage