Validation Services
Validation Services
According to the FDA, validation consists of “Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.”
Online Business Applications can help minimize the effort and frustration surrounding validation by assisting with customization of the validation documents to meet your specific business and QA needs, as well as the requirements of the FDA.
Online Business Applications offers three different validation packages. You always have the ability to customize the documents included in any package.
Basic Validation Package
The basic validation package consists of several standardized regression test scripts that are intended to apply to any system configuration. Your company’s validation department is responsible for customizing these documents to meet internal needs.
Full Validation Package
With the full validation package, OBA is responsible for complete validation and document customization, from initial planning to the final summary report. The end result is a fully validated IRMS application, without the need to burden your internal QA department. The following documents are included:Custom Validation Package
The custom validation package allows you to meet your internal validation requirements without the need to customize every one of the necessary documents. You can pass along a portion of the work to OBA, choosing a subset of documents from the Full Validation Package for OBA to customize.