Statistica 10 Manual

Business White Paper

21 CFR Part 11 Compliance Using STATISTICA

Last Updated: April 2003 This document was updated to reflect the FDA’s latest guidance (released February, 2003) and the withdrawal of previous guidance.

U.S. Headquarters: StatSoft, Inc.
Australia: StatSoft Pacific Pty Ltd. Brazil: StatSoft Brazil Ltda. Czech Republic: StatSoft Czech Rep. s.r.o. France: StatSoft France2300 E. 14th St.

Tulsa, OK 74104

USA

(918) 749-1119

Fax: (918) 749-2217

info@statsoft.com

www.statsoft.com

Germany: StatSoft GmbH Hungary: StatSoft Hungary Ltd. Israel: StatSoft Israel Ltd. Italy: StatSoft Italia srl

Japan: StatSoft Japan Inc. Korea: StatSoft Korea Netherlands: StatSoft Benelux BV Poland: StatSoft Polska Sp. z o. o.

Portugal: StatSoft Iberica Ltda.Russia: StatSoft Russia Singapore: StatSoft Singapore S. Africa: StatSoft S. Africa (Pty) Ltd.

Spain: StatSoft Espana Sweden: StatSoft Scandinavia AB Taiwan: StatSoft Taiwan UK: StatSoft Ltd.

STATSOFT BUSINESS WHITE PAPER | 21 CFR PART 11 COMPLIANCE

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Table of Contents
Executive Summary........................................................................................................ 3 Overview of the Regulation ............................................................................................. 3 Relevance to STATISTICA Applications.......................................................................... 4 STATISTICA’s Approaches for Compliance.................................................................... 4 The STATISTICA Document Management System......................................................... 5 Conclusions .................................................................................................................... 8 References ...................................................................................................................... 9

U.S. Headquarters: StatSoft, Inc.
Australia: StatSoft Pacific Pty Ltd. Brazil:StatSoft Brazil Ltda. Czech Republic: StatSoft Czech Rep. s.r.o. France: StatSoft France

2300 E. 14th St.

Tulsa, OK 74104

USA

(918) 749-1119

Fax: (918) 749-2217

info@statsoft.com

www.statsoft.com

Germany: StatSoft GmbH Hungary: StatSoft Hungary Ltd. Israel: StatSoft Israel Ltd. Italy: StatSoft Italia srl

Japan: StatSoft Japan Inc. Korea: StatSoft Korea Netherlands:StatSoft Benelux BV Poland: StatSoft Polska Sp. z o. o.

Portugal: StatSoft Iberica Ltda. Russia: StatSoft Russia Singapore: StatSoft Singapore S. Africa: StatSoft S. Africa (Pty) Ltd.

Spain: StatSoft Espana Sweden: StatSoft Scandinavia AB Taiwan: StatSoft Taiwan UK: StatSoft Ltd.

STATSOFT BUSINESS WHITE PAPER | 21 CFR PART 11 COMPLIANCE

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Executive Summary
StatSoft, provider of theSTATISTICA 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 andQuality Control processes. STATISTICA is used within organizations in applications where the FDA’s 21 CFR Part 11 regulation is applicable. The STATISTICA software suite aids organizations in their compliance efforts by meeting all of the requirements of 21 CFR Part 11. StatSoft, through its Technical Services group, provides software validation services as part of the deployment of STATISTICAapplications.

Overview of the Regulation
In 1997, the FDA released the final version of the 21 CFR Part 11 regulations. The regulation provides the framework in which organizations are able to produce, store and provide secure access to electronic records. The scope of the regulation includes any area where paper-based records had been required. 21 CFR Part 11 is relevant when those paper-based...