JETT-Blende URS.docVIP

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JETT-Blende URS

User Requirements Template for a BLENDER for Pharmaceutical products NOTES for use of the User Requirements Template: Upon completion of the template, delete this page prior to updating the Table of Contents and printing. Many areas of this template have selections or tables that have been prepared for guidance and ease of template completion. Text in italics is intended to be used as notes to the User and should be deleted prior to printing. Any options and/or examples that are not applicable to the specific document being created should be deleted as well. To update the final Table of Contents, place the cursor inside the shaded area, press the Right mouse key, and select Update Field. Where possible, the User should identify the source (e.g. studies, standards, etc.) for the acceptable ranges of variables or other critical requirements that have been derived. REVISION HISTORY Rev. Date Approval Revision Summary 0 July 27, 2003 Vince Miller (JETT) Approved for initial, formal release. Table of Contents 1.0 Introduction 5 2.0 Overview 5 2.1 Use: 5 2.2 Capacity: 5 3.0 Operational Requirements 6 3.1 Capacity 6 3.2 Process Requirements 6 3.3 Process Control 7 3.4 Functions 7 3.5 Data and Security 13 3.6 Environment 17 4.0 Constraints 20 4.1 Milestones and Timelines 20 4.2 Equipment Constraints 21 4.3 Compatibility and Support 21 4.4 Availability 23 4.5 Procedural Constraints 23 4.6 Maintenance 25 5.0 Life-Cycle 25 5.1 Development 25 5.2 Testing 25 5.3 Delivery 26 5.4 Support 27 6.0 Glossary 28 7.0 References 29 8.0 Approval 30 Project No.: Insert the unique project number associated with this particular URS. Document No.: Insert the Document Identification Number and Revision. Document Description: Insert description of document, e.g. BLENDER User Requirements Template, JETT Example User Requirements Specification. Introduction This document was generated under the authority of the ___________________ Company for the purpose of specify

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