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LMS for successful compliance management

Due to the ever-increasing number of complex legal provisions and changing standards, more and more companies are faced with the challenge of ensuring quick and efficient implementation of compliance requirements. To fulfil both general and internal standards, numerous companies are still resorting to antiquated and time-consuming processes. Various data is being prepared manually and often does not fulfil the requirements of legislative bodies.

One simple option for supporting integrated and efficient compliance management in a company, covering all its locations, is the implementation of a learning management system (LMS).

Using an LMS, it is possible to not only deliver e-learning trainings but also to organise and document traditional on-site training events. It is also possible to use a system of this kind to examine and check at any given time the compliance status of an organisation or part of an organisation.

So in the case of an internal or external audit for example, there is no need to collect the relevant data from different sources. This data is anytime available to the management to assess the risks associated with breach of the regulations. The associated administrative tasks are kept to a minimum.
But not every learning management system is suitable for effective and legally compliant compliance and training management. What are the requirements that have to be fulfilled?

Role-specific compliance support in the daily work routine

A good LMS should primarily support users as required with different tasks with their daily compliance requirements.

The employees
The employees in a company require an overview of all courses they have to attend content information and their previous learning progress. Convenient and individual access to the courses should be guaranteed for every learner at all times. It should also provide an overview of course deadlines and requested “passed” by dates   as this is vital to the learner to not lose track of things in their daily routine.

As the world of work is becoming increasingly mobile, an LMS must offer users the option of accessing the media from any location, at any time and from any mobile device.

Reliable digital signatures ensure that users always have the opportunity to confirm their course participation or register for a course.

The compliance officers
 For compliance officers, a simple user management system represents one of the most important priorities. They must be able to assign tailored courses to different user groups, register individual users or user groups on courses and also see at a glance employees’ course deadlines.

The auditors
The primary expectation of both internal and external auditors when it comes to effective compliance support provided by an LMS is that it is able to generate meaningful compliance reports for parts of an organisation or individual training measures and to check by way of random sampling the compliance status of individual employees.

Flexibility and support services
 The corporate world never stands still. New compliance standards appear regularly, guidelines are updated and expanded, companies expand and open branch offices at new locations.   A compliance and training management system must be configured in such a way that it can be adapted easily to reflect those changes.

A cloud-based learning management system can react flexibly to all these changes and immediately adapt the learning environment to the new circumstances. Due to the high level of flexibility and independence of existing IT resources, it is possible to compliance trainings immediately. The maintenance and regular system updates are performed by the provider. So the compliance officer can concentrate exclusively on his tasks.


Elaborated identity management with e-signatures
Specific framework conditions apply to the use of an IT system, such as an LMS within compliance processes. The most important guideline for this is 21 CFR Part 11 from the US Code of Federal Regulations, published by the Food & Drug Administration (FDA). This guideline governs the handling of electronic data (electronic records) and the storage of electronic signatures for the validation of processes for companies in the fields of pharmaceutical products, medical devices, foodstuffs and biotechnology.

For medicines and medical products provided in the USA, an FDA licence is mandatory. 21 CFR Part 11 is now regarded as a reference guideline in other industries where similarly stringent guidelines have been adopted. An appropriately prepared LMS can support you in compliance with FDA 21 CFR Part 11 and corresponding GxP guidelines.

For more information please go to http://www.im-c.de/en/compliance-learning/

By the way, IMC has been awarded with the prestigious Brandon Hall Silver Award for excellence in the category “Best in Compliance Training”.

www.im-c.com

 

 

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