Pharmaceutical manufacturing processes are subject to stringent validation requirements to ensure product (drug) quality. This industry is critical to society’s health and well-being – thus, their processes must be highly regulated.
StatSoft understands the importance of the pharmaceutical industry and provides validation services to help customers install and use STATISTICA in validated environments. Many STATISTICA installations have been used for validated processes in the pharmaceutical industry and have been operating successfully in this environment for many years.
- Comprehensive Solution: A team of experienced and skilled professionals to perform planning, implementation, and documentation for installations of STATISTICA that are used in validated processes.
- Standardized Deliverables: A standard set of validation deliverables (User Requirements Specification, Functional Requirements Specification, Validation Plan, Test Plan, etc.) that can be used as part of 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 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.