SOLUTIONS

Overview

Audit Management

Batch Records System (EBR)

Change Control

Complaints Handling

Corrective/Preventive Actions (CAPA)

Device History Records (DHR)

Deviations

Document Control

Engineering Change Orders (ECO)

Equipment Calibration

Investigations

Nonconformance Management

Out of Specification (OSS)

SOP and Document Management

Training Management and Certification

Training Management and Certification

Quality Manager’s Training Module helps manage and control role-based training requirements and employee certifications. The automated processes and task manager reduce training costs and shorten time-to-compliance, as well as keep management up to date on the progress of their employees’ training status. Training managers can easily set-up courses and schedules tied to specific requirements.

The software's flexibility allows you to create and deploy a variety of simple or extensive training courses requiring users to learn their duties and demonstrate proficiency, matching qualified personnel to job requirements. Automatic reports inform trainers who signed up for a class, as well as employees that will lose certification without completion of courses. Trainees benefit from online registration, automatic notifications, requirements tracking and task management capabilities. Finally, automatic grading of online exams gives instant feedback to employees as well as managers to trainee’s progress.

Moving to an electronic system provides a secure, centralized repository for all training-related documents. The Training Module allows for development of a progressive training program through sequencing of training courses and/or tasks. As soon as a trainee completes a prerequisite, the next course/task is automatically launched. A full escalation model is available for overdue tasks or training events.

Courses can be created for online participation or in a classroom setting. With the group sign-off feature, the course instructor or verifier can sign off once for large groups of trainees. Trainees have access to their training history as well as upcoming courses they need to complete by deadline.

When training is integrated with the Document Control Module, employees are automatically notified when required SOPs or other documents change, and new tasks are automatically assigned. In addition, when the Quality Management Module is integrated, a “closed loop” Quality Management System is created vastly reducing costs and increasing quality and compliance.

The compliance history capability verifies that a worker maintained qualifications throughout their employment. Training coordinators can monitor the compliance of all employees with the help of the automatic reports and trend analysis tools. A variety of reports are loaded into the system, but companies can customize reports based on their needs.

Training Capabilities:

• Allows users to view training tasks and training records in their dashboard

• Allows users to sign electronically after completing training tasks

• Synchronizes changes between documents (e.g. SOPs) and their associated courses

• Automatically triggers any required training based on linked document changes

• Provides reporting of real-time data based on current status of all training tasks

Some of the reports available include:

Training Summary: Gives a top level view of all the training courses in the system, with employees that have signed up or completed the course.

Training Detail by Employee: Summary of courses completed by employee within a specific date range.

Certification Status: Lists status of certification by employee by department with upcoming courses needed to maintain certification and deadlines.

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