Ofni Systems can validate all of your software, databases, spreadsheets, and computer systems, and develop the appropriate documentation for all phases of the software life cycle.
We have written (and executed) commercially available validation packages.
If your software validation process requires adherence to FDA regulation CFR Title 21 - Part 11, you can find more information about this regulation and Minitab Statistical Software at: Minitab and Compliance with CFR Title 21 – Part 11 - ID 2588 For additional questions about our internal software validation process, please contact us.
Computer Software Validation is a formalized, documented process for testing computer software and systems, required by 21 CFR 11.10(a) and Annex 11, Section 4.
If the script does not cover all the tools you use, it can be used as a template for your validation efforts or you can contact our consultants for assistance.
Download the Minitab 18 Software Validation Kit For clarifying examples regarding software validation, visit the Minitab blog.
Failure to validate systems is one of the leading reasons a business is issued a 483.
We use our proprietary tool Fast Val to write validation documentation and execute Testing Protocols, which allows us to complete validation projects in 70% less time than traditional validation methods.
Validation can be described as verifying that you are building what the customer wants.
" On the other hand, software validation is: "Was X what we should have built? " Building the right product implies creating a Requirements Specification that contains the needs and goals of the stakeholders of the software product.
If such artifact is incomplete or wrong, the developers will not be able to build the product the stakeholders want.