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Categories SOPs_Available SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP 04-Software Development & Validation Group (All SOP's listed below)

Categories SOPs_Available SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP 04-01 Software Development Process

Categories SOPs_Available SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP 04-02 Software Level of Concern

Categories SOPs_Available SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP 04-03 Software Configuration Management

Categories SOPs_Available SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP 04-04 Software Requirements Specification

Categories SOPs_Available SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP 04-05 Software Hazard Analysis

Categories SOPs_Available SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP 04-06 Software Anomalies

Categories SOPs_Available SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP 04-07 Software Validation

Categories SOPs_Available SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP 04-08 Source Code Review Procedure

Categories SOPs_Available SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP 04-09 Algorithm Test Procedure

1 - 10 of 15 results

04-Software Development & Validation Group (All SOP's listed below)

$1,800.00


This group contains SOP's which will guide you through the software development and validation process
Browse this category: SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP

04-01 Software Development Process

$150.00


This SOP describes the risk based software development process and the software life cycle. It covers Level of Concern, Development Plan, Risk analysis, Requirements Specification and Validation. (18 pages)

$150

Browse this category: SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP

04-02 Software Level of Concern

$125.00


This SOP provides guidance to determine Level of Concern as defined by the US FDA for software. (5 pages + 1 report form)

$125

Browse this category: SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP

04-03 Software Configuration Management

$150.00


This SOP defines requirements for configuratiom management including methods to control and number documents and revisions. (5 pages)

$150

Browse this category: SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP

04-04 Software Requirements Specification

$150.00


This SOP describes methods to develop a risk based Requirements Specification including Use Case Analysis. (10 pages + 1 report forms)

$150

 

 

Browse this category: SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP

04-05 Software Hazard Analysis

$175.00


This SOP describes procedures for conducting Hazard Analysis for software. Software HA is conducted differently than hardware HA. For instance probability is not considered.(13 pages + 3 forms)

Webinar slides are included. They explain the SOP in detail and explain the context of the SOP. They could be used for training.

$175

Browse this category: SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP

04-06 Software Anomalies

$150.00


This SOP controls the process of tracking and resolving development problems and anomalies. One form is included. (5 pages + 1 report form)

$150

Browse this category: SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP

04-07 Software Validation

$200.00


This SOP describes and controls the software validation process. (11 pages + 3 report forms)

$200

Browse this category: SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP

04-08 Source Code Review Procedure

$150.00


This SOP describes procedures for reviewing source code as part of software validation, (4 pages)

$150

Browse this category: SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP

04-09 Algorithm Test Procedure

$125.00


This SOP describes the procedure for conducting  calculations of algorithms as part of validation. (5 pages + 1 report form)

$125

Browse this category: SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP
1 - 10 of 15 results
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SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP