LMS – Learning Management System and GMP Training
AmpleLogic GMP software like Learning Management System (LMS), GMP Training software has been developed in such a way that it manages and oversees an array of on-the-job and research trainings in pharma, healthcare-specific employee training, development and research cycle starting from induction for employees to the final training completion. These trainings are carried out so that team members and employees are better equipped for the roles that have been designated to them. All of these trainings are done in accordance with standard operating procedures (SOP), and policies and also ensure that they meet the compliance requirements as per 21 CFR Part 11, EU Annex 11, MHRA, GMP or cGMP and other regulatory standards
Learning Management System is a web-based platform that we designed, developed and tested overtime to be efficient in carrying out very effective employee training and learning activities, tracking and completion enables you to carry out effective employee learning activities, tracking, and completion. This software solution also helps in scheduling and reporting staff activities to enable organizations better equip and improve overall control on a day to day basis. AmpleLogic Employee Training Tracking Software has been designed with an ability to connect with a bio-metric device to ensure that employees learn effectively under highly secure access.
We also have a follow up system called the Pharmaceutical Training Management Software. This solution gives you unlimited access to the entire training process within a well-laid out systematic plan that includes proper scheduling of activities and trainings. This is accompanied with continuous tracking and follow-up, thus allowing companies to meet easily with global regulatory and company-specific requirements across the organizations. In essence, this Training, Reporting, and tracking are performed within the LMS platform and are made to seamlessly integrate with other risk and compliance functions such as corrective action, change management, and document management system.
Challenges with Paper based training system
Presently, the Pharmaceutical industry is guided by a variety of laws and regulations to ensure the safety and efficiency of products and production processes. It is also important to note that Compliance Training is very relevant in the healthcare and pharmaceuticals for its functions cannot be overemphasized. In addition to SOP, cGMP and Safety learning is also made mandatory to make sure that employees are properly equipped to work within the industry guidelines to enhance their qualifications.
There is need for proper documentation of learning sessions during training processes. This will help facilitate audits carried out by the US FDA and MHRA Non-compliance to set standards and rules have serious legal repercussions and also greatly affects product quality. This depreciation on in quality causes organizations to incur losses due to inefficiencies.
To fast track training processes and record keeping, the pharmaceutical companies are opting for online learning and web-based platforms such as the Learning Management System. Due to strict policies set by authorities for compliance tracking, has become essential for companies to coordinate their activities effectively in order to stay in business and avoid government scrutiny. Training Management System is relevant when personnel require a thorough training in complex and professional tasks that require unique and distinct skill-sets and regular sessions like in information storage.
Features and Benefits of Employee Training Tracking Software
AmpleLogic FDA 21 CFR Part 11 GMP Training and Tracking module is developed to provide smooth learning, on-the-job training across the organization. Therefore, our Pharmaceutical Compliance Training Modules is known for its effectiveness in enhancing production. It also aids production by giving an insight into what the operator wants to know and features a calendar and column for individual records. Our systematic approach has been thoroughly assessed and approved by admins all over the world and trusted by leading companies. Below is the list of some key offerings for our unique LMS
- AmpleLogic Learning Management System supports multi-languages. It also allows for seamless integration with QMS, DMS and HR modules. Works with a special Bio-metric fingerprint technology.
- It is designed in compliance with 21 CFR Part 11 requirements such as electronic signatures, audit trails, secure password authentication etc.
- Organization of online and offline training sessions can be done easily with the Training Calendar and Schedule option.
- Trainees are assigned specific course levels to enhance trainings.
- The system has different certification types e.g. questionnaire, practical and verbal discussions.
- The Learning Management System is user-friendly and frequently updates the competency needs and progress of employees in training.
- It has the ability of retraining and also act as a trainer to each person.
- The system is accompanied with logs that contain dynamic reports and matrices.
- Allows for timely distribution of alerts and notifications to all defaulters regarding calendar schedule, pending tasks, upcoming progress and incomplete or completion of their training processes.
- It ensures good manufacturing practice and on the job training via yearly training schedules and external training programs
- AmpleLogic LMS solution automatically tracks all learning sessions, record, and histories
- It enables managers easily identify defaulters at risk of falling out of compliance with their learning requirements. It makes use of online dashboards and easy-to-use search tools to do this.
- The employee training software system automatically creates new records which are assigned if the user is matched to the required user group based on their job responsibilities, functions, competencies, and updates when the change control has been approved.
- It can immediately prepare reports for management, client, regulatory and auditor requests.
- It automatically cancels scheduled sessions when users are changed to other departments or divisions.
- Aids in the revision of the training materials and auto update of the scheduled sessions with the latest version of the training material.
Benefits of AmpleLogic Training Management System
- It can be accessed anywhere in the world as it is web-based. The Training Management Software allows for request managements and also provides a centralized location for all the activities.
- This Learning Management System (LMS) accommodates all training information into a single system and this makes it easy to ensure that each staff member receives appropriate learning and training.
- The system automatically records and documents all trainings conducted for the purpose of detailed audits.
- Training Management Software eliminates non-compliance to regulatory bodies and ensures process automation at zero cost of process change.
- AmpleLogic LMS System is defined as a 4 staged approach that fits into Learning Automation Objectives. Also, business/ Functional Requirements can be defined based on the first stage of implementation without causing any change.
- AmpleLogic provides the best solution (functional and Technical) that will address automation need as per 21 CFR Part 11 and EU ANNEX 11 Compliance with a strong knowledge of QMS and GMP.
- Completion is guaranteed with seamless integration with QMS modules like Change Control, CAPA and this integration is carried out at a very minimal cost.
- It produces metric reports or trends that are exclusively analytical, visually eye-catching and very easy to comprehend.
- This SOP Training Software ensures efficiency across the organization in carrying out its activities as it is goal oriented, web-based and user-friendly.
- LMS Module eliminates and replaces the manual processes to reduce the risk of unnecessary human errors.
- The system ensures that industry cGMP practices, government regulations, and ISO standards are complied with
- Our online learning will also increase training transparency by giving an analysis that suits the organization needs.
- This Learning Management has been patterned to reduce risks of poor quality products by triggering ad-hoc training and continuous process for all industry personnel.
AmpleLogic LMS has been painstakingly designed with several modules that allows organizations to manage their training’s effectively and this is asides the fact that it ensures compliance to regulatory standards and ensures effective Learning Management