GMP and SOP Learning Management and Tracking Software

AmpleLogic GMP software like Learning Management Software (LMS) has been built to manage pharma-specific employee training and it’s life-cycle starting from induction till employee’s total tenure in the organization as per 21 CFR Part 11, EU ANNEX, GMP and other regulatory requirements. AmpleLogic Biochemical Learning Management system provides the web-based training session, exams and instant evaluation which gives an edge to end-user that enables organizations to create interest and improve overall control on day to day training process. It also connects with a biometric device to ensure 100% training to an employee with high security.

AmpleLogic Pharmaceutical Learning Management Software (LMS) enables you to take control of the entire training process. Systematic training plan, schedule assignment with continuous tracking and follow-up, thus allowing pharma companies seamlessly to meet global regulatory and company-specific requirements across the organizations.

Training, Tracking and Reporting are performed within the LMS interface as other risk and regulatory compliance functions such as corrective action, change management, audit management, incident management, SOP management etc.

Challenges with the current manual system:

Today’s pharmaceutical industry is governed by a variety of laws and regulations to ensure the safety and efficiency of its products. Compliance training is critical in the healthcare and pharma industry. In addition to SOP training, cGMP training, Safety and Environment training is mandatory to make sure that employees are equipped to work within the industry guidelines. Subsequently, the training process is continuous and has become necessary to record and document all conducted training for detailed US FDA and MHRA audits. Not only does non-compliance have serious legal repercussions but it also affects production quality and cause losses due to inefficiencies.

Due to these reasons, Pharmaceutical companies are opting for professional services like Training Management System (TMS). Due to the stringent policies for compliance, training and tracking has become essential for companies to stay in business and avoid government scrutiny. Information storage as well as training personnel for such elaborative and complex tasks requires excellent skill-sets and periodical trainings and this is where the role of a Training Management System comes in the forefront.

Learning Management and Tracking Software Features:

AmpleLogic cGMP Learning Management and tracking Module is designed to provide smooth Training across the department. AmpleLogic Pharmaceutical LMS improve the transparency across department throughout the training process where the user would know the list of training that he needs to attend, training Calendar, upcoming training and individual training records etc. Our systematic approach has been liked by admins & trusted by leading companies. Below is the list of some key offerings for our LMS.

  • Training Calendar, Training schedule and option to organize online and offline sessions.
  • Training on the course level and material levels.
  • Different certification type e.g. questionnaire, practical and verbal discussions.
  • Retraining, training & trainer feedback and training history of each person.
  • Supports multi-languages and integration with biometric & HR modules.
  • User-friendliness with dynamic reports and matrices.
  • Email notification, Timely training schedule alerts escalations to defaulters on pending schedule
  • Integration with QMS and DMS.
  • Creation of GMP, COP and External Training Programs.
  • Timely reports and metrics on training schedules and completeness.
  • Tracking of training progress.
  • Automatically record training histories.
  • Email notification / Alerts of schedules, Upcoming progress.
  • Dashboard interface.
  • Discover audit trails and e-signature for updating training records.
  • Easy to monitor and update the competency needs of employees.
  • Managers can easily identify the team members that are in danger of falling out of compliance with training requirements using online dashboards and easy-to-use search tools.
  • Incomplete training of the employee can be notified to the quality assurance team and management, based on a pre-defined and fully configurable escalation path.
  • Consolidation of all training information into one system streamlines the administrative effort, making it easy to ensure each staff member receives the appropriate training.
  • Automatically creates new training records and assigns them to employees based on their job function and competency and updates when the change control has been approved.
  • Effectively communicates training activities and efficiently coordinates managers and employees.
  • Immediately prepare reports for management, client, regulatory and auditor requests.

Benefits of AmpleLogic Learning Management software:

  • Enterprise-wide 24 x 7 accessibility to Learning Management Software to manage trainings requests and requirements.
  • Consolidation of all training information into one system streamlines the administrative effort, making it easy to ensure each staff member receives the appropriate training.
  • The continuous training process for all industry personnel.
  • Records & documents all training conducted for the purpose of detailed audits.
  • Eliminates non-compliance.
  • AmpleLogic defined 4 stage approach that fits into Training Automation Objectives. Business/ Functional Requirements can be defined based on the first stage of implementation, results in no cost of change.
  • Supports Indian languages, no need to change infrastructure. Works with Bio-metric fingerprint technology.
  • With strong domain knowledge in QMS and GMP Area, AmpleLogic provides the best solution (functional and Technical) that will address the training automation need as per 21 CFR Part 11 and EU ANNEX 11 Compliance.
  • Easy interface and integration with QMS modules like change Control, CAPA and minimal cost of integration, results in 100% training completeness.
  • Ensures higher efficiency and compliance rate.
  • Escalation via auto-alert.
  • Provides a centralized location for all training activities.
  • Metrics reports or trends that are exclusively analytical and visually eye catching.
  • User friendly solution that improves effectiveness and efficiency across organization.
  • Eliminates the need for manual processes, greatly reducing the risk of human error.
  • Ensures compliance with industry cGMP practices, government regulations and ISO standards.
  • Increases training transparency by giving an analysis catering to organization training needs.
  • Ensures training process automation at zero cost of process change.
  • Reduces risks of repeat quality events by triggering ad-hoc training.

Apart from being an industry standard and effective Training Management solution, AmpleLogic Learning Management Software has several modules that enables organizations to manage trainings effectively.

Individual Employee Training Records


Training Need Vs Departments


Employee Training Profile
Yearly Training Matrix Department-wise VS Employee-wise