Learning Management System
21 CFR Part 11 and EU GMP

The Employability Manager is the Learning + Training Management System for high risk industries that are bound to legislation of the FDA (CFR 21 Part 11) and EU (EC: Eudralex Volume 4 Annex 11)

Does your organization work according to GMP (Good Manufacturing Practices )guidelines, which are set up for the pharmaceutical companies and other highly regulated industries? In which case you are required to accurately maintain the compliance of employees. Managing this process however can be a complex and time consuming process. What you are looking for is a software system that makes managing of training and education easier, yet at the same time complies with the regulations that apply within your industry.

The Employability Manager offers you the support and ease-of-use to help you maintain the compliance levels of employees. It is also a software system which contains all of the components required to be allowed to use within high risk industries:

Audit Trail:

To keep track at what is done in the system all critical actions are logged. The Audit trail records all changes and planned courses, registrations, log-ins etc. This includes the person who makes the actions and the date of the action. Even when these actions are made automatically by the system itself, for example planning a course again for the set interval time. This gives you the control to keep track of all the changes made in the system, who has made them and when.

Electronic signature:

To be able to execute critical actions within the system it is possible to make use of an electronic signature. This function will ask for a authorized person to fill in his or her user-name and password via a pop-up screen. For all e-signatures the audit trail records for which action it is, who has signed it and when. Once the proper person has filled in the proper details the action is executed by the system.

Electronic signature is used for allowing a person to fill in a course or for registering a training.

Validation:

The Employability Manager is elaborately tested and validated, both by ourselves and by our customers. To guarantee quality every new version is developed, tested, validated and rolled out according to strict procedures. We also give customers the opportunity to validate new developments themselves if they wish to. Already since 1998 various customers have validated the Employability Manager.

Other components

On the job training at which somebody is step by step learning to execute certain actions independently can easily be managed in the Employability Manager.
You can keep track of their process and see whether somebody is learning, can work under supervision, can work independent or can teach others. The employability of an employee is only increased once all steps are registered in the system. On the job skills can also be recorded, you can read more on skills here

Training records provide insight per employee and per training course. You are able to see who has followed a certain training course, when is was taken and the date of the rescheduling. It is also possible to see which courses an employee has done and which still need to be taken to get a 100% employability for a certain function, activity or work place.

Compliance / employability: With a few clicks it is possible to get an overview of the employability or compliance for every employee and department. You get a clear overview of the employability percentages and in the same overview you'll see a division of the courses passed, instructions (SOP) read and skills meeting their target. Click on an employee's name to get a detailed overview of the state of all courses, instructions and skills for this employee.

Personal plan board: Every employee has his own overview of training courses, on the job trainings, SOPs, class trainings etc. The overview clearly shows the what the plan date is of when the training should be finished/read. Is a course passed it expiration date an alarm will appear. Changes in an SOP are also clearly visible in the overview with the date when the SOP needs to be completed. An employee can also find his learning history in this screen and even plan himself for certain courses.

Audits: With the help of the Employability Manager you do not have to worry about audits any more. Using a software system all training records are up-to-date and available when you need them. No longer do you have to collect all data from everywhere in the company. You simply login and all the data an auditor might ask about is available within a few clicks. The Employability Manager makes your life even more simpler with by automatically re-planning courses and sending you a notification if an employee is late completing a course.

Developed by:

OverNite Software Europe BV
Transportlaan 93
6163 CX Geleen
The Netherlands

T: +31 (0) 46 4200 933
F: +31 (0) 46 4200 934
info@ose.nl
www.ose.nl

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