Med Device Advisors Sells Medical Device SOP's

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Categories SOPs_Available SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP 04-10 Software Unit Test

Categories SOPs_Available SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP 04-11 Software Integrated Unit Tests

Categories SOPs_Available SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP 04-12 Software System Test

Categories SOPs_Available SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP 04-13 21 CFR Part 11 Conformance

Categories SOPs_Available SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP 04-14 Validation of Off The Shelf (OTS) Software

11 - 15 of 15 results

04-10 Software Unit Test

$125.00


This SOP describes the procedure for conducting Unit tests. The SOP contains 5 pages and 2 report forms.

$125

Browse this category: SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP

04-11 Software Integrated Unit Tests

$125.00


This SOP describes the procedure for conducting software integrated unit tests (5 pages+ 2 forms)

$125

Browse this category: SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP

04-12 Software System Test

$125.00


This procedure describes the procedure for conducting a software system test (5 pages + 1 form)

$125

Browse this category: SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP

04-13 21 CFR Part 11 Conformance

$200.00


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.

$200

Browse this category: SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP

04-14 Validation of Off The Shelf (OTS) Software

$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

Browse this category: SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP
11 - 15 of 15 results
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SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP