“How am I going to find a system to deploy to 12-20 countries around the world?” Each one has it’s own regulations and requirements for training…”
“I work for a pharmaceutical company? Is there a Learning Management System (LMS) that meets the very requirements of the FDA?"
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The SuccessFactors LMS answers these common questions by providing features that support US, French, and German requirements. At this point you may also be asking: Does it completely meet the requirements? Does it do everything I ever hoped and dreamed it could do?
Perhaps - I’ll leave that up to you and your legal department.
Let’s go in to a little more detail about how the system supports regulations in the following industries and countries:
- FDA 21 CFR Part 11 (medical and pharmaceutical companies)
- E-Signatures
- Audit Tables
- French Government and French Work Councils
- 2483 Reporting
- DIF Tracking
- Training Planner
- German Privacy
- US Federal Government Agencies
- EHRI
- SF-182 External Requests
- Manufacturing and other industries requiring worker qualifications
US FDA 21 CFR Part 11
Intended to protect the public against manufacturing defects and anomalies in production of medical goods and pharmaceutical products, 21 CFR Part 11 includes regulations that govern the use of electronic signatures in food and drug related industries.
The SuccessFactors LMS implemented two major features to support the regulated medical industry:
1. Electronic Signatures
21 CFR Part 11 requires an additional password when recording learning events. When E-Signatures are activated in the SuccessFactors LMS, users must enter an additional password. This password is used only when recording learning. This comes into play in two situations:
- Learning is recorded manually - Admins and Supervisors record learning for others and are prompted for the secondary password before learning is recorded.
- Users complete online training. Typically online learning is recorded automatically. When E-Signatures are active Users must enter the secondary password before learning is recorded.
2. Audit Trails
Companies are audited regularly to ensure compliance, and must produce reports demonstrating that e-signatures are properly recorded. The LMS maintains audit tables on important data including changes to learning history, user, items (courses) and curricula. If an Admin has modified a learning history record, a report will show this change. The following reports are available on audit tables:
- Curriculum Summary Data Audit Report
- Item Summary Data Audit Report
- User Custom Field Data Audit Report
- User Summary Data Audit Report
- User Learning Plan Audit Report
French Work Council
The French government as well as work councils in France impose certain training requirements on employers operating in France. Employees must be given the opportunity to complete a certain amount of training each year and the time spent in training must be accounted for. When training takes place outside of normal work hours employers may be required to compensate employees for that time. The French government requires 2483 Reporting, which details the dollars spent on training and the amount of training delivered to employees. A percentage of revenues is collected and applied towards training some of which helps train people who are out of work.
The LMS supports the following regulations applied to companies in France by the French national government and by work councils:
- DIF Tracking
- 2483 Reporting
- Training Planner to forecast training budgets
German Privacy Regulations
The German government requires employee data be deleted from all systems 5 years after the employee has left the company. A process called the “Purge Deleted User Audit History” automatic process deletes user data after X days. The number of days can be set to any numeric value. It is not required to be set to1826 days (5 years), so companies can be stricter than the German government requires. Companies outside of Germany can be less stringent as they are not required to comply with German regulations.
US Federal Government
Support for US government agencies is extensive, as the SuccessFactors LMS is the system of choice for most US federal agencies. Two features in particular were implemented to support the US Federal Government regulations. The requirements were specified originally by the Office of Personnel Management (OPM) and generalized for companies to use if they wish.
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External Requests - Originally called SF-182 forms, External Requests provide an alternate way to request and record training by filling out a form that specifies the costs and duration of training - and requires approval from supervisors and other parties before training begins. A verification process is included, which applies an approval process to the verification of training after it has been completed. Typically users in the federal government use this feature to obtain approval for the estimated cost of training and to document the actual costs of training.
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EHRI - There is an entire set of functionality most people never see called EHRI. EHRI is a specific set of regulations requiring federal agencies report all training data to OPM. The original idea was to provide a single training record for all government employees so that when employees change agencies (very common), the training record remains intact. Two issues were discovered in the implementation:
- Agencies utilize many different types of systems including major LMS vendors, Access databases, and Excel spreadsheets - integrating this data into one feed with common fields is quite the task and has taken several years (with continuation)
- Training is not standardized across agencies; while similar training may be offered in multiple agencies and could be considered the same course for qualification purposes, they often have different names and IDs. In addition, it is not clear from basic data how similar these courses may be. The task of determining what training an employee needs based on his/her past records can be difficult until these courses are standardized.
Given all that, EHRI is supported. The LMS supports loading private data including Social Security Number and Date of Birth through a feed from the HRIS directly into the LMS. PII fields are never displayed to admins and users. It is imported through a system interface, stored in encrypted tables, and exported to a standard reported transmitted through SFTP to OPM.
Employee Qualification
One other area to consider is employee qualifications. These may be strict regulations imposed by a third party or they may be internal training requirements that determine employee eligibility to work. Employees not up to date on training may be prevented from doing their job until required training is complete.
The primary feature that supports employee qualifications is Curricula. Curricula were at one time (very early versions) called Qualifications, and some database fields and code still refer to qualifications. Don’t be surprised to find the phrase QUAL when you dig deep into the underlying properties files of the system.
Employee qualifications follow a general pattern:
- Read a document and verify that the user "read and understood” - at one time this was accomplished with a handwritten signature. Today it is accomplished by pushing a button in the LMS next to the statement “read and understood”
- Complete training - this training may be Instructor-Led, Online, or both
- Demonstrate performance on the job - On the Job is a combination of training and demonstration. In some cases it is a hands-on mentoring process, in others it is similar to an evaluation. The application even supports checking off completion of tasks on the job through the “Tasks” feature. Fun side note - this feature works on iPads, so you can walk around the shop floor checking off tasks as they are completed.
- Manually Record Authorization (optional) - some companies have an admin or supervisor manually record authorization and may enable these people to rescind that authorization at a later date if the employee demonstrates poor performance.
Final Thoughts…
As you can see the SuccessFactors LMS has extensive support for a wide range of both government and industry regulations across the globe. Companies operating in multiple countries should consider regulations when choosing an LMS, and ensure that whatever the choice the system does in fact support the applicable regulations. You wouldn’t want to find yourself in the middle of legal issues and fees now would you?!
Disclosure: My company has a business relationship with this vendor other than being a customer: We're a SAP and SuccessFactors partner.
Bhupesh, until you see the needed improvements in the solution's built-in analytics, how have you been compensating for the need to market for multiple clients' requests?