Validating employee training programs

For sake of audit, a qualification report can be created to indicate that the employee has met his or her training needs.If divided like this, the change control and system validation must operate in a clear, defined way so that developmental records do not affect the validated system.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.When a worker takes part in development and performance management activities, these should not affect the qualification of the said employee, and should fall beyond the validated condition.Life science companies are increasingly investing in holistic talent management systems (TMS), where learning management presents an important feature.However, the question that arises at this juncture is what exactly does FDA anticipate the company to validate?During a typical GMP on-site inspection, an FDA investigator may request to assess the qualifications of an employee and the auditing team would have to present the history and documentation of qualification.

Part 11 applies to any record where a company produces, maintains, modifies, archives, transmits, or retrieves in electronic form.

Figure 1 shows the advantages of a combined system.

Life Science companies investing in talent management platforms should ensure that qualification requirements of employees comply with the stringent validation requirements stipulated by both EMA and FDA.

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).

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