FDAnews Quality Training Advisor

Selecting an Electronic Training Documentation System

Dec. 3, 2014

Electronic training documentation systems, known as Learning Management Systems (LMS), are increasingly popular in the pharmaceuticals industry.

An LMS is essentially a database made up of multiple tables to store discrete units of information. These might include employee information, course information, evaluation data, and training programs or materials. These tables can be merged and queried to produce specific reports. Report capabilities allow users to compare, analyze, question and project needs.

Selecting an LMS and integrating it with your training program can seem a daunting prospect. Break the task into three stages to make it more manageable.

Stage One: Planning

The first step is to establish a review and selection team. As with any team, the fewer the number of players, the easier it will be to reach consensus on key issues. But certain functional areas should be represented. People or departments that should be considered for the review team include a training manager, trainers and representatives from various departments, such as Human Resources, Information Systems and Quality Assurance.

The team then must address several important issues, including who will enter data, who will have access to data, how data will be stored and how the system will interface with existing HR and other company databases.

Data Entry

Data entry is a key component of any electronic documentation system. In fact, the system will only be as good as the data entered. It is also important to note that data entry offers an opportunity for system corruption if not handled expertly.

Methods of data entry vary from company to company and sometimes even from facility to facility within companies. Some organizations use paper copies  of sign-in sheets  and provide test results  to a dedicated data entry  person   whose  sole  job  is  to  enter information into  the LMS. In other companies, the trainer is responsible for entering the data. Then there are companies where data entry tasks are handled by management-level staff. Deciding the best approach for your company is the first issue the team must tackled.

Often, data entry is assigned to someone other than a full-time company employee. This frees up training professionals from data entry tasks but presents another set of problems. For instance, entry-level clerks, contractors or temporary employees may not have the experience to evaluate the accuracy or plausibility of the data they enter. And a part-time person may not be able to keep up with the amount of data to be entered.

A good argument exists for using experienced employees for data entry. For instance, an experienced employee may  question a record that shows an employee was trained on 30 SOPs in one 2-hour time period. This kind of checking helps ensure the accuracy of the data, a critical element in electronic recordkeeping.

Data Access

Another important question is: Who will have access to the data? Access – and therefore security – typically falls into three levels: system administration, data entry and system users. System administration usually involves the training manager and a person from the IT department dedicated to the LMS.  System administrators have complete access to the LMS and can view data design or generate queries, replace or add data, and revise system capabilities, if necessary.

Data entry includes people who can enter information into the system. Security for data entry personnel allows them to view the system and add data to it. Beyond that point, they are locked out and cannot change or modify the system.

System users may include all facility employees. This level allows employees to be responsible for their own training. They can generate reports to determine which programs they have completed and which programs they must take to remain competent in their jobs or satisfy state or federal training requirements. Likewise, supervisors and managers have the ability to query the system to determine which employees are qualified to perform job functions and who is up-to-date on required training. Typically, security for system users allows them only to read data and print reports.

Data Storage

Who will store the various forms of training documentation and for how long? Many training departments continue to store sign-in sheets, paper tests or other forms of raw data even though they have an electronic system because of confusion about what the FDA expects. According to Phil Pontikos, Consumer Safety Officer with the FDA’s Columbus, Ohio, office, the agency is more interested in evidence of employee competence than it is in raw training data.

If the course content, method of evaluation and trainees' scores have been recorded, there is a complete picture of employee training and workforce capabilities to perform a certain task. Of course, employment law or internal HR policy may require documentation of actual test failure to demonstrate poor performance.

System Interface

How will this information interface with existing HR systems and databases? Many companies require that only one database on employee information be maintained. In this situation, a separate database for training administration would be redundant. The team must consider whether the LMS will interface (read from and feed into) an existing HR system? This is one reason to have a representative from the HR department on the planning team.

In next week’s issue, we’ll cover Stage Two: Identifying System Needs.

Contact Information:
Dave Gallup
GMPTraining.com, Inc.
18585 Coastal Highway
Unit 10, #149
Rehoboth, DE 19971