Validated Reporting

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Validated Reporting

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.

STATISTICA Solution

  • 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.
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About statsoftsa

StatSoft, Inc. was founded in 1984 and is now one of the largest global providers of analytic software worldwide. StatSoft is also the largest manufacturer of enterprise-wide quality control and improvement software systems in the world, and the only company capable of supporting its QC products worldwide, with wholly owned subsidiaries in all major markets (StatSoft has 23 full-service offices, on all continents), and its software is available in more than 10 languages.

Posted on October 2, 2013, in Uncategorized. Bookmark the permalink. Leave a comment.

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