SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP

SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP

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This SOP group describes procedures to control the software development and validation process including off the shelf software and 21 CFR part 11 compliance.

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$1,600.00
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)
$125.00
This SOP provides guidance to determine Level of Concern as defined by the US FDA for software. (5 pages + 1 report form)
$125.00
This SOP defines requirements for configuratiom management including methods to control and number documents and revisions. (5 pages)
$125.00
This SOP describes methods to develop a risk based Requirements Specification including Use Case Analysis. (10 pages + 1 report forms)
$125.00

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.

$150.00
This SOP controls the process of tracking and resolving development problems and anomalies. One form is included. (5 pages + 1 report form)
$125.00
This SOP describes and controls the software validation process. (11 pages + 3 report forms)
$150.00
This SOP describes procedures for reviewing source code as part of software validation, (4 pages)
$125.00

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

$125.00
This SOP describes the procedure for conducting Unit tests. The SOP contains 5 pages and 2 report forms.
$125.00
This SOP describes the procedure for conducting software integrated unit tests (5 pages+ 2 forms)
$125.00
This procedure describes the procedure for conducting a software system test (5 pages + 1 form)
$125.00

This SOP describes the procedure to create electronic records and electronic signatures that are in conformance to Part 11. (5 pages + 3 forms ).

Webinar slides that explain the SOP and the context of the SOP are included. These could be used for training.

$150.00
This SOP describes the risk based procedures for validation of purchased off the shelf (OTS) software whether used in a device, used in the production of a device or or in laboratory/ Quality systems supporting the device development (8 pages).
$150.00