Software Tool Validation Combo


Tools to get your Production and QMS Software validated – At warp speed!

Software used for automating Medical Device QMS or Production processes requires validation per the following standards:

  • FDA – 21 CFR Part 820.70(i)
  • FDA – 21 CFR Part 11
  • ISO13485:2016 – Sections 4.1.6, 7.5.6, and 7.6

This includes – Document Control software, Manufacturing software, LIMS, Calibration software, Complaint Handling software, ERP software, CRM software.

Examples of such software are – Mastercontrol, JIRA, SpiraTest, TestRail, Jama, TrackWise, Trello, Salesforce, Git, and ClubHouse.

Note: This combo does not include any tools for validation of medical device software (e.g. medical device firmware, SaMD, software that is an accessory to a medical device, mobile medical apps). A separate product is available for this purpose.

The Software Tool Validation Combo includes two critical tools:

  1. Very simple, yet fully compliant, SOP that includes requirements for validating purchased software used to automate your QMS or production processes, and
  2. Templates to help you quickly, yet comprehensively, document software requirements, testing protocol, and testing report for a software tool.

This combo is perfect for situations where:

  1. You have an upcoming audit, and need to validate asap to avoid findings.
  2. You have a device launch at risk of delay, because Quality department is asking for “tool validation” (e.g. JIRA, TestRail, Jama).

We believe that we have developed world’s simplest method for software tool validation. If there is a simpler way, please let us know and we will give you 25% discount on our other products.

SKU: STVC1 Category: