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GxP Compliance: The Importance of Employee Training Automation


In GxP compliance environments, the importance of having a well-trained and reliable workforce cannot be overestimated. In the life sciences sector, where life-saving knowledge and compliance procedures are continually being developed and must be consistently updated by workers, quality training is of special importance. Employees whose training is up to date can be trusted to help steer the company toward its goals. Furthermore, since a company’s goals are not static but must be continually updated with the changing landscape of the industry, employee training is vital to keeping the organization up to date. 

Using software for employee training represents good guidance, safety, and management practices. In fact, it enhances and complements any quality management system by having the potential to fulfil a variety of GxP and by carrying the following benefits: 

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Scilife's Employee Training Module


User-friendly software

Well-designed and engineered employee training software GxP compliant should allow a variety of indispensable training tasks to be programmed and ultimately automatized across your organization. It must support the easy creation and implementation of such processes as document assignments, the establishment of links to important external files, and the design of training methods. User-friendly software should allow managers to easily input training materials and tasks. This way, managers will acquire the freedom to customize training and retraining materials in precisely the way required by their specific groups of workers.


Streamline the training process

In fact, by creating and defining user functions across the organization, good employee training software will give managers a chance to intimately analyze the needs of their departments. Once created, the software should help to streamline the training process and to ensure that all employees are exposed to comparable levels of training. It should also allow managers to keep better records of the training material to which each employee has been exposed. 


Automate training and retraining

Furthermore, because the process works best if completely automated and while including completion statuses for each employee, managers should be able to know with certainty whether employees have completed their designated training within the allotted time. And because the system will also automatically follow up with employees for retraining if necessary to ensure that the important knowledge and skills are acquired and maintained, it provides quality assurance that safeguards the lives of those who consume health care and pharmaceutical products organizations offer. 


Audit readiness

Additionally, training automation ensures compliance with the various regulations and standards that secures the credibility of your organization in the pharmaceutical and life sciences industries. For stakeholders who have vested interest in the organization’s functioning or for the purpose of scheduled or impromptu audits, the ability to create reports that store, translate, and communicate the data about employees’ training outcomes also will provide a clear benefit.


Centralize training data

The system should therefore allow managers and instructors (or course designers) the flexibility to input user data, and that information must then be convertible and/or downloadable in formats compatible with a variety of other systems. This way, this centralized data becomes easily accessible to the departments and personnel that are authorized to view and handle them. It must be possible also to allocate and manage such authorization to ensure that data is handled with as high a level of security as is necessary when employees’ sensitive information are involved.  


Comply with relevant regulations

Of utmost importance to organizations in the pharmaceutical or life sciences industry is compliance with government board regulations. The training software should be developed to allow users strict adherence to 21 CFR part 11 Compliance and Annex 11 guidelines. This means it should facilitate methods that will support the trust, reliability, and fidelity of the digital records and signatures your training materials both use and may themselves constitute. Thus, training manuals created within the system should comply with required protocols that make them amenable to validations, audit trails, documentation and any other predicate rules set forth by the FDA. 


Software vendor support

Finally, good software companies always stand by their product and by the customers who place their trust in the software. It is therefore important to choose the right company to handle your training automation. Once you have adopted the software to support your workforce’s training, your provider should be on call at all times to ensure that the training and GxP compliance requirements are always met.

Your employees are your most valuable resource, and their ability to learn and stay trained will give organizations in the life sciences and pharmaceutical disciplines a competitive edge with respect to a variety of good practices (GxP). Well-designed and automated training software helps managers develop their human resources in the present as well as prepare for future training interventions. It should also support the scheduling of ad hoc or retraining modules when necessary in order to support employees’ thorough understanding of the material. Finally, any training software should exhibit properties of a quality management system, ensuring ease of documentation and digital signing as well as being audit-friendly, so that not only will the company establishes and remains in compliance but it will also secure the trust of its consumers. 


The requirements of Life Sciences companies (including in the pharma and medical device space) inevitably change over time. Sometimes, a change is due to regulatory requirements; sometimes, customer needs change. Keep reading if you want to...