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eTraininfo

Automates life sciences training management, ensuring compliance with 21 CFR Part 11 standards, featuring paperless tracking, role-based reporting, and training records management.

Solution by CIMCON Software
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Overview

The eTraininfo Training Management System is tailored for the life sciences sector and provides a comprehensive solution to automate training processes, enhancing both compliance and productivity. This sophisticated system complies fully with 21 CFR Part 11 regulations, enabling organizations to manage training records without paper usage, ensuring consistent adherence to regulatory standards.

A notable feature of eTraininfo is its detailed validation package, which accelerates system validation and implementation. This package is prepared by experts, ensuring a streamlined deployment process for users. The software’s design accommodates usage by individuals, departments, or as part of a company-wide initiative to maintain compliance.

Benefits

  • Facilitates documented self-training.
  • Establishes training needs based on job titles.
  • Generates role-based reports and dashboards for efficient tracking.

Features

Training Records Management
  • Determines training needs automatically.
  • Schedules and registers training based on assessed requirements.
  • Keeps comprehensive training records.
  • Reviews training needs after document updates.
  • Handles refresher training requirements.
  • Offers scheduled, ad-hoc, and self-training options.
  • Includes online training assessments.
  • Provides training material management and email notifications.
  • Collects feedback from trainers and trainees.
Wide Range of Built-In Reports
  • Reports on training needs by employee or department.
  • Tracks training records by employee, document, or department.
  • Monitors overdue training sessions.
  • Analyzes refresher training requirements.
  • Details training schedules and registrations.
  • Executes training analysis by department or company.
  • Compiles trainee feedback.
  • Displays role-based dashboards.
21 CFR Part 11 Compliance
  • Maintains an audit trail noting date, time, user ID, changes made, and actions for all training activities.
  • Incorporates detailed security rights and role assignments.
  • Supports electronic signatures complete with user ID, printed name, date, time, and signature meaning.
  • Implements password aging and account lockout after retries.
  • Enforces automatic session timeouts to ensure security.

Meta

Category
Regulatory & Quality Compliance
Field(s)
Quality & Compliance
Target user(s)
QA / Regulatory AffairsLab Manager / Core Facility Manager
Tag(s)
Quality & Compliance Management