Validating an HR-Related System: What Would FDA Say? 

Q: We’re having an internal debate about validating an HR-related system.

We understand FDA expects us to validate manufacturing or operational-related systems such as manufacturing execution systems (MES), laboratory information systems (LIMS), quality management systems (QMS), and learning management systems (LMS).

But does FDA expect validating an HR-related system that only stores an employee’s developmental skills and competencies (such as communication and leadership abilities and technical skills)?

We believe a fine but definite line exists between a regulated “qualification or training record” and an unregulated skills development rating transcript. Would an FDA inspector agree — or would FDA say a system that monitors skills development also needs to be validated?

A: I believe there is indeed a very fine line here that must be defined clearly when you’re considering validating an HR-related system.

Let’s start with the basics:

FDA says personnel must have the education, experience, and training to do their current job. In the Quality System Regulation, FDA added the word “background” and expects that qualification also.

Within your HR system, you must have information that shows each employee has the knowledge, skills, and/or abilities needed to do the job. Where the person lacks those qualifications, you must have a training or development plan to bring the person to the appropriate level.

When hired, most employees provide a CV or written/signed application showing their background and knowledge. In general, most new employees don’t have specific knowledge of company SOPs, policies and forms. So that kind of training and development is usually what you put on their training plan.

In addition, FDA regulatory awareness usually is part of their initial training plan, especially if the new hire has not worked previously for an FDA-regulated company.

Then after initial training, you should do refresher training on the regulations and requirements as well as training needed as processes and procedures change within the company.

FDA investigators definitely will look at employee CVs, job descriptions, and training records to assure individuals have the knowledge, skills, abilities and background to be in their jobs. If FDA finds the documentation lacking, the investigator likely will issue a 483 citation stating that the personnel are not qualified to do their jobs.

Now let’s look at your specific situation:

Some personnel will have the same job over their entire career. Any additional growth opportunities documented within an HR system for these employees would be of no interest to FDA because they don’t pertain to the job at hand.

However, there may be times that line employees will want to move into Quality Assurance positions or laboratory functions. Personnel who run the warehouse may want to become manufacturing or line operators. Line operators may want to learn how to program so they can do the set up on machines and not just run them. Employees may want to become team leaders or supervisors.

If companies provide developmental opportunities that, upon successful completion, qualify the employee for other job functions — and if companies want to use those developmental records to demonstrate the employee is now qualified for the additional job responsibilities — then I believe FDA would be interested in reviewing the validation of that type of system.

[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]The bottom line is: “What is the intended use of the system and the records the system will contain?”[/pullquote]

As always in determining whether a system must be validated, the bottom line is: “What is the intended use of the system and the records the system will contain?”

If the system stores an employee’s “developmental skills and competencies” (communication and leadership abilities and technical skills) and the intent is to use that information to demonstrate that the person is qualified to fulfill additional job functions or assigned tasks, then the system needs to be validated.

If the system is used to determine what type of training plan an individual needs based on mapped skills and competencies and provides employee “skill ratings” to determine job functions, FDA might be interested to ensure the employee was appropriately trained before he/she took over additional job functions.

On the other hand, an HR system that merely maps communication styles and leadership abilities not tied directly to specific job functions now or potentially in the future would not be of interest to FDA.

Rarely is any system totally black or white when it comes to validation. It all comes down to how you are going to use the system and what kind of records it contains, including when you’re considering validating an HR-related system.

Answered by Janis Olson, Vice President of Regulatory and Quality Services for EduQuest, who served 22 years at the U.S. FDA as an expert field investigator and was the director of information management resources for FDA’s Atlanta regional office. Jan also is the co-instructor of EduQuest’s three-day training class on FDA Auditing of Computerized Systems and Part 11/Annex 11 Compliance.


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