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This article describes a model through which FDA-regulated organizations can confirm the LMS part, instead of the whole TMS, which could contain tools focusing on competency management, performance management, and goal setting.

The QA and IT validation teams as well as the TMS sponsors, which often include the HR team, can realize several benefits by directing the validation effort on the “qualification record.” According to FDA, “validation” is defined as the establishment of “ FDA states that validation of computer systems is a documented, formalized procedure used for testing computer systems and software needed by Federal Regulations (21 CFR 11.10.a).

It is felt that specifiers, contractors, manufacturers and other end-users will feel more comfortable in using installers that have completed installation training as outlined in SWR Institute’s Validated Training Program.

The following SWR Institute volunteers are available to mentor you through the Training Validation Program process: Submission The Validated Training Course must include certain minimum standards to be considered.

Monitoring If the training program is validated, the company must provide a monitor or proctor to be present during the training to insure that the training complies with the guidelines of the Validated Training Program Agreement.

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