Learning / Quality Management System MODULE

The Learning / Quality Management System Module is developed to manage:

  • Quality Management System
  • Trainings
  • Audit program and CAPA
  • Vendors

QMS management

The module is designed to store and manage Quality Management documents (SOPs, policies, guidelines, instructions, JDs, etc.). All of the documents are therefore digitally stored in the Quality Management System section, which enables the use of automated workflows. Keeping QMS documents electronically has many advantages:

  • Access to all documents at any time, from any place
  • Access to all documents and their last version or status
  • All documents are easily accessible via internet
  • No possibility for unauthorized access to QMS
  • No possibility to lose documents
  • Decreased margin of errors
  • Documents expiration control and alerts
  • High level of security
  • Remote audit readiness

Learning management

Learning / Quality Management System Module goes with inbuilt learning Management System to efficiently manage organization’s training processes.

The module is used to create, assign, assess, track, monitor and report, trainings seamlessly:

  • To develop assignment matrix and acknowledgement status
  • To upload trainings in different format including ppt and video trainings
  • To assign trainings to employees
  • To perform a self-training proven by an electronic signature
  • To get access to training documents at any time, from any place
  • To remind employees about trainings via e-mails and color alerts in the system
  • To perform knowledge testing via test. Trainer can assign the questions (evaluation) and answers and the passing score for the training
  • To perform retraining
  • To provide training log
  • To inform line managers about non completion of the training
  • To track all training activities
  • To get access to trainings logs
  • To oversight trainings

The benefits of eLMS are training logistics costs elimination, compliance risks reduction and quality management improvement.

Audit program and CAPA management

The module allows to perform audit and CAPA management as a part of QMS activities – management of internal, external, vendor and study audits, non-conformances, document management, change control. The module allows to capture quality events like non-conformances, complains and deviations. The system allows to track progress from creation, investigation, and root cause analysis, to CAPA, validation of successful outcomes and CAPA closure. The module can assign CAPA-related tasks to the team, remind about pending actions and track progress through to completion.

Vendor management

The module allows to manage, qualify and rank vendors which are/are not allowed to be used in clinical trials.