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StatSoft, provider of the STATISTICA product suite, is committed to partnering with our customers in meeting our mutual goal of the design and production of products of the highest quality and reliability. Many of our customers in FDA-regulated industries, such as the design and manufacturing of pharmaceutical and medical device products, rely on STATISTICA as an integral software tool within their Research and Development and Quality Control processes.
StatSoft, through its Technical Services group, provides software validation services as part of the deployment of STATISTICA applications. The following sections provide an introductory overview to our standard Validation Package for STATISTICA applications deployed within your environment. These services include requirements gathering and documentation, validation planning, installation qualification, operational qualification and performance qualification.
STATISTICA is used for many applications where computer systems validation is relevant.
For example, STATISTICA is used by organizations:
For each of these applications, STATISTICA may be used for any combination of the following activities:
Depending upon the application, the data and results used for these purposes may be subject to the rules of the 21 CFR Part 11 regulation.
StatSoft's Technical Services Group provides a standard Validation Package that can be customized to suit the relevant STATISTICA application. Our Validation Package is a combination of a StatSoft team, a suite of services, and a set of documentation. Each of these components is covered in more detail below.
StatSoft provides its Validation Package as an integrated set of services to augment our standard system design and deployment methodology. We standardized the Validation Package to provide an enhanced suite of services to our clients in regulated industries.
Your organization is able to leverage our combination of STATISTICA expertise and validation expertise. What this means to you is a streamlined approach to validation with significant cost and time savings.
Please contact StatSoft Technical Services at 918-749-1119 (email email@example.com) for more information about our Validation Package to suite your STATISTICA application needs.