Traditionally, a paper based processes like spreadsheets, word documents and legacy systems has been used in life sciences, pharmaceutical, medical devices, biotechnology and other drug manufacturing organizations for documenting all training programs, progress of employee trainings and training completions and it is critical that organizations are able to keep the accurate documented records of individual employees 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, paper based and legacy systems fails to deliver in a larger organizations for many reasons. Firstly, the sheer bulk of the word documents, excel sheets and records to be maintained hence it leads to inefficiencies in a system. It also makes audits very difficult, time-consuming and cumbersome process, which in turn causes further failings of a system.
However, the US FDA (Food and Drug Administration) has mandated that all the companies operating in regulated environments need to implement and adopt computerized software systems which should comply with 21 CFR Part 11 requirements like electronic records, password authentication, audit trail and electronic signatures.
The systems that are implemented in the regulated industries must follow the three protocols called IQ, OQ, and PQ.
IQ indicates for a “Installation Qualification.” The IQ records the installation of the software and ensures that the installation follows the proper steps.
OQ indicates for a “Operational Qualification.” The OQ tests or qualifies that the solution is properly working using test data in a general.
PQ indicates for a “Performance Qualification,” which means that the application, under real life conditions, it consistently will produces products which meet all the predetermined requirements.
Evaluation of Vendor for LMS System
While there are many GMP Learning Management Software Systems available in market today, only a few can help healthcare, life sciences, pharma, biotech, manufacturing and medical devices companies to comply with US FDA 21 CFR Part 11, GMP, EU Annex 11, MHRA and other regulatory standards. If these software system does not maintain these compliance requirements, the US FDA can impose serious penalties or issue the warning letters for the organizations.
Organizations must ensure that LMS software providers or vendors should have significant experience in implementing a proper learning management software for various pharma and life sciences companies. There are few must have key functionality features that will be very important for any company to maintain a flexible and a scalable platform and that can easily be integrated with a multiple applications as well as with third party systems to meet the various needs of an organization. AmpleLogic had successfully implemented its GMP Training Software Systems in several life sciences, pharmaceutical industries across the globe.
Advantages of Learning Management Systems
Apart from maintaining the compliance requirements, a Pharmaceutical Learning Management System (LMS) web based solution can prove to be extremely efficient to deal with all training requirements of the organization.
- Auto Notifications, Alerts and Escalations can be automatically triggered through emails as soon as a learner or employee has been assigned with a training course.
- The highly configurable nature of AmpleLogic SOP and GMP Training Software enables your organization to manage all learning programs, training records, delivering trainings and along with other processes, using one centralized repository system.
- AmpleLogic Training Management Software Solution helps to create unlimited number of user groups based on job titles, functions, work profiles, roles, departments or locations and easily schedule and assign training requirements to specific sites or teams or user groups.
- Changes in training materials (for instance SOPs, procedures and work policies etc.) can automatically trigger an email alert or notification to learners who need to be trained on the revised training materials or courses.
- Generate custom reports of training planned and completed for each employee are available at all times, easing the audit process.
- It eliminates wasted time spent, resources, and money lost through inefficiencies in managing your organization’s employee training programs through spreadsheets, word documents or other databases.
- Online assessments for leaning courses can be conducted with the help of quizzes, puzzles, random questions, blank questions, match the following, yes or no, and image based questions. All the training records of these evaluations are available at all times for audit purposes.
The Training Management Software System not only helps companies to comply with mandatory compliance trainings but also helps in increasing the efficiency of the workforce as well as achieving excellence in product quality.
AmpleLogic GMP and SOP 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 to achieve all the learning goals within an organization.
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.