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Software Validation

If you are regulated by the Food and Drug Administration (FDA) and need to validate our software for 21 CFR Part 11 compliance, then our software validation product is right for you. Each of our products has been validated to assist you in being compliant with all Part 11 rules. By purchasing our validation package, you are helping to ensure you are prepared to pass an audit from the FDA.

Our software validation packages come with the following:

  • The Installation Qualification (IQ) to help you install/configure the software correctly.
  • The Operational Qualification (OQ) with test scenarios and a signed cover page as proof of validation.
  • A permanent link to the documents and particular version/revision of the validated software (including all addendums).
  • A letter from Prolink's president stating the software has been validated.

Validation packages are valid at the site level. They are purchased once regardless as to the number of copies of the software you own at the same physical site. Each validation package comes with unlimited updates to the revisions within the current version of the software product you have purchased. Therefore, if you have purchased QC-CALC RT 3.3.10 and Prolink re-validates at revision 3.3.20, you automatically qualify for the latest revision of the validation package without extra cost.

Upgrades to the validation package follow upgrades to the software which is being validated (specifically major or minor version number changes – i.e. 3.3 to 3.4 or 3.3 to 4.0). The upgrade and maintenance price of the validation packages are the same percentages as the software. Therefore, when you upgrade your software, you will pay an upgrade price on the software itself and a separate upgrade price on the new version of the validation package. Similarly, the annual cost of maintenance will be calculated as a percentage of both the software and validation costs.

Also available but not included in the validation price are implementation and training packages. These are 2-3 days in length and are charged at the regular daily rate. Please see our onsite training option on the training page for pricing. The daily rate is the same whether we are doing training or validation.

Available Product Validation Packages
 PriceAdd to Cart
QC-CALC Real-Time 3.4 Validation Package$5,000.00
QC-CALC SPC 3.4 Validation Package$5,000.00
QC-Gage 3.4 Validation Package$2,000.00
SPC Office Buddy 3.4 Validation Package$2,000.00
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