Many manufacturing processes are subject to stringent validation requirements to ensure product quality. Accordingly, industries critical to a healthy and orderly society--especially those involving pharmaceuticals, medical devices, etc.--are highly regulated.
StatSoft understands the importance of these industries and provides specific services to help customers install and use STATISTICA in validated environments. Many such STATISTICA installations have been operating successfully in these environments for many years.
- Comprehensive Solution: A team of experienced, skilled professionals will plan, implement, and document the entire installation of STATISTICA in validated processes.
- Standardized Deliverables: We offer a standard set of validation deliverables (User Requirements Specification, Functional Requirements Specification, Validation Plan, Test Plan, etc.) that can be included in validation documentation for processes that use STATISTICA.
- Flexible Customization: Customized validation services to meet individual customer needs.
- Audit Trail: STATISTICA has built-in audit trail options to maintain a thorough record of all changes.
- Compliant with Major Regulations and Standards: STATISTICA is compliant with FDA 21 CFR Part 11, Sarbanes-Oxley, and ISO 9000, 9001, and 14001.