Validating training

Should a person possess an undergraduate degree plus two years of experience before applying for a management position? When time-in-grade or other training, experience, and education (referred to hereafter as TEE) requirements are used and generate adverse impact, they instantly become subject to validation scrutiny if challenged in arbitration or legal settings.Because TEE requirements are frequently established using nothing other than 'best judgment' by executive and management staff, employers often find themselves in litigation situations explaining to the judge why they thought a five-year minimum time-in-grade requirement was better than a four-year requirement, or three and onehalf years – down an endless slippery slope of subjectivity. There are several defensible methods for validating TEE requirements....

In order to simplify the validation process, IT and QA experts at UL Edu Neering have proposed a new model, where a Talent Management Suite of applications are segmented between the “Performance Management Record” and the “Learning and Qualification Record” for individual employees.

However, the question that arises at this juncture is what exactly does FDA anticipate the company to validate?

The focus behind this question is the fact that both EMA and FDA expect software that could interact with the yet-to-be validated quality system, and this would comprise of the learning management system (LMS) that stores records related to qualification and training.

The following are the main validation requirements: In order to deal with these regulatory obligations, Life Science companies carry out several activities for systems that affect the “quality system”, producing the design document, conducting performance testing, developing test scripts, developing functional and user needs, etc.

The validation effort is quantified in sunk costs, such as the time required by salaried validation and IT teams as well as adding many months to deploy the software.

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