Quality Procedures P 5.1: Verification and Validation of Business and Process Software 1.0 Purpose: This document describes the types of software used within the organization and defines the level of verfication or validation required for its installation and use, 2.0 Scope: document pertains to software, exclusive of that developed for use in products, used for test, process control and business applications with in 3.0 Responsibilities: Itis the responsibility of Management to determine the Project Manager for any installation or upgrade to the busness application software. Itis the responsibility of the Project Manager to manage the verification and validation of any installation or upgrade to the business application software. Itis the responsibility of Manufacturing Engineering to verify and validate any manufacturing software used to test or control the process of manufacturing product. Itis the responsibility of the individual user to verify and validate any customization of standard off-the-shelf software. 4.0 Defini Business Applications Software refers to software used to manage and control the company business process of entering orders, processing orders, managing inventory, shipping orders, and handling financial transactions related to the business. Off-the Shelf Software refers to commercially available software. Firmware refers to software which is encoded onto programmable devices. ‘Approvals: Senfor Management Quality Assuranc Date: 1/13/00 Page 102, Revision: AVerification and Validation of Business and Process Software PSARevA Customized Off-the-Shelf Software refers to commercially available software which has been customized via a macto or by special request to the vendor and is used in the production or testing of product. ‘Templates refer to software that can be configured in a predetermined or pre~ programmed manner only. Examples include Label generation software and CNC machines. 5. Procedure: ‘A. Software requiring verification and validation includes any business applications package, process control and test software, and customized Off-the-Shelf software that is used in the design manufacture or test : product. B. Software exempted from verification and validation activities include any customized Off-the Shelf software that is not used in the design, manufacture or test of product, template software, and software that may affect quality but whose output is 100% inspected and verified against its specification, per a controlled work instruction. C. Revalidation is required when the software requires validation per section 5A, and a change has been made to the original validated version. D. Any software requiring verification or validation will fall under document control as defined in P 5.0. E. Business applications software will be validated per QA 14.1. F, Process Control software will be produced under design controls, per G. Customized Off-the-Shelf software is validated, and the results documented and controlled by the individual user who creates the customization. H. Firmware is validated in accordance with the Gating Process used for the new product under development. ‘Transonie Systems Inc. Page 2 0f 2