Training Management Solution for Pharmaceutical Industry

Training Management Solution for Pharmaceutical Industry

Traditionally, a paper-based and legacy systems has been used in life sciences, pharmaceutical, biotechnology and other drug manufacturing organizations for documenting all training completions and it is critical that organizations are able to keep the accurate records of individuals and their training plans. But as these companies grow in size and geographical locations, they have to move towards computerized systems to maintain efficiency. The hybrid and paper-based system fails to deliver in larger organizations for many reasons. Firstly, the sheer bulk of the documents and records to be maintained hence leads to inefficiencies in the system. It also makes audits difficult, time consuming and tedious process, which in turn causes further failings of the system.

However, the FDA (Food and Drug Administration) has mandated that regulated environments need to implement and adopt computerized systems which comply with 21 CFR Part 11 compliance requirements like electronic records, electronic signatures.

The systems that are implemented in the life sciences industry must also follow three protocols called IQ, OQ, and PQ.

IQ stands for “Installation Qualification.” The IQ records the installation of the software and ensures that the installation follows the proper steps.

OQ stands for “Operational Qualification.” The OQ tests or qualifies that the solution is working using test data in general.

PQ stands for “Performance Qualification,” which means that the application, under real life conditions, consistently produces products which meet all predetermined requirements.

Evaluation of Vendor for LMS System

While there are several GMP Learning Management Software Systems available in the market today, only a few can help life sciences, pharma, healthcare, biotech and medical devices companies to comply with FDA 21 CFR Part 11, EU Annex 11, MHRA and other regulatory standards. If these system does not maintain these compliance requirements, the FDA can impose serious penalties on the organizations.

Organizations must ensure that LMS vendors should have significant experience in implementing learning management software for various life sciences companies. There are few must have key features that will be important for any organization to maintain a flexible and scalable platform and can easily be integrated with a variety of third party applications to meet the various needs of an organization. AmpleLogic has successfully implemented its GMP Training Software Systems for several pharmaceutical companies across the globe.

Advantages of Learning Management Systems

Apart from maintaining compliance requirements, a Learning Management System (LMS) based solution can prove to be extremely efficient to deal with the training requirements of the organization.

  • Email Alerts, Notifications, Reminders and Escalation can be automatically triggered through emails as soon as a learner has been assigned a training course.
  • The highly configurable nature of AmpleLogic SOP Training Software enables your organization to manage all training records, along with other processes, using one centralized repository system.
  • AmpleLogic Training Management Solution can create unlimited number of user groups based on job titles, work profiles, roles, departments or locations and easily schedule and assign training requirements to specific sites or teams or user groups.
  • Changes in training material (for instance SOPs, work policies etc) can automatically trigger an alert to learners who need to be trained on the revised training courses.
  • Generate custom reports of training planned and completed for each employee are available at all times, easing the audit process.
  • Eliminate wasted time, resources, and money lost through inefficiencies in managing your organization’s employee training program through spreadsheets or other databases.
  • Online assessments for courses can be conducted with the help of quizzes, puzzles, blank questions and tests with randomized questions. Records of these evaluations are available at all times for audit purposes.

The Training Management System not only helps organizations comply with mandatory trainings but also helps in increasing the efficiency of the workforce and achieving excellence in product quality.

AmpleLogic Training Management Software could not only be compliant with the 21 CFR Part 11 regulations, it also complies with SCORM making our product a robust system that will help you achieve all the learning goals.

To learn more about how AmpleLogic Training Management System for Life Sciences, Biotech and Pharmaceutical companies which can meet your training and certification needs, please contact us for a free schedule of demo.

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