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.