eTraininfo

eTraininfo Training Management System

Designed specifically for the life sciences industry, the eTraininfo Training Management System automates your training processes for improved compliance and productivity. eTraininfo is fully compliant with 21 CFR Part 11 requirements and hence can be used for paperless tracking and management of training records. An available validation package accelerates system validation and deployment.

eTraininfo Validation Package:  A comprehensive and detailed validation package written by validation experts is available for quick and easy implementation.

21 CFR Part 11 Compliance:  Allows paperless training processes and operations.

The software is designed to be used by single users, departments or as part of a corporate initiative for 21 CFR Part 11 compliance.

  • Paperless management of training records for improved compliance and productivity
  • Wide Range of Reports instantly highlight training requirements and change impact
  • Easy to configure, use and maintain
  • Reduced validation effort using available validation package
  • Zero Client Web Based solution – no installation required on desktop

Training Records Management

  • Automatic determination of training requirements
  • Schedule training based on needs assessment
  • Register persons that need training
  • Maintain training records
  • Assess training requirements following a document version change
  • Assess refresher training requirements
  • Schedule, Ad-Hoc and Self Training option
  • OnlineTraining Assessment
  • Training Material Management
  • Configure email notifications
  • Trainer and Trainee Feedback

Wide Range of Built-In Reports

  • Training Requirements by Employee or Department
  • Training Records by Employee, Document or Department
  • Overdue Training
  • Refresher Training Requirements
  • Training Schedule
  • Training Registrations
  • Training Analysis by Department or Company
  • Trainee Feedback
  • Wide range of role based dashboards

21 CFR Part 11 Compliance

  • Audit trail records the date, time, user ID, old value, new value and action for all training activity
  • Comprehensive and detailed assignment of security rights, privileges and system roles
  • Configure actions that require electronic signatures that include the userid and printed name of the signer, date and time, and the meaning associated with the signature
  • Password Aging forces a new password after a configurable period
  • Account lockouts after a configurable number of retries
  • Automatic Session time-outs

Installation

  • CSI offers installation services to install the software. Installation services can ensure proper system installation and operation in your computing environment during initial system start-up and implementation.

Data Migration

  • CSI offers data migration services to migrate data from your legacy systems and applications to eInfotree.
  • Recognizing that data migration is a critical component in the validation of any computer system, CSI offers services for preparation and execution of Data Migration Protocols to accompany the data migration effort.

Product Configuration

  • CSI offers Product Configuration services to configure eInfotree to your specific requirements and applications.
  • CSI’s product experts can help you optimize your implementation of eInfotree and derive a maximum return on investment based on a keen understanding of business processes, industry best practices and product knowledge.

System Integration

  • System integration services include an analysis of existing business systems and applications, an understanding of customer’s business needs, and designing and executing a system integration plan to integrate eInfotree with existing applications to optimize the eInfotree implementation and maximize return on investment.
  • These services also include technical analysis to identify validation issues and preparing validation plans, procedures and protocols to validate the integration effort.

Validation

  • CSI offers a validation package that includes Functional Specifications and Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols. CSI products are rigorously tested and validated internally following an ISO 9001 certified and FDA-recommended practices and procedures based on using a Software Development Life Cycle (SDLC) approach.

Training

  • CSI offers training services geared towards eInfotree users, administrators, and “train-the-trainer” services.
  • Training can be scheduled onsite or offsite.

Product Maintenance and Support

  • CSI product support and technical services are just a phone call away. CSI standard support services include technical support via phone, email or online support tools, as well as product upgrades and new versions. Premium 24 x 7 support services are also available.

Electronic Records and Audit Trail

Audit Trail:

  • Stores all user actions in an audit trail with timestamp, user ID, action performed, old value, new value, Meaning, device id, Description and reason fields as applicable.

Administrator Audit Trail:

  • Stores all administrator actions such as e-signature configurations, reason field assignments, user management, and user privileges.

Configurable Reason Fields:

  • Set to optional or required based on object/action combination.

Electronic Signatures

E-signature Templates:

  • Create e-signature templates defining the operations that require e-signatures

Configurable E-Signature Assignment:

  • Different templates can be applied to different actions for unlimited flexibility and control.

E-Signature Roles:

  • Define meanings (roles) for e-signatures and restrict user authority for e-signatures to specific roles.

Security

Protection of Data:

  • Data is stored securely in the system database.

Role based Assignment:

  • Assign roles like Training Manager, Trainee, Trainer, Department Manager etc. to each users.

Role Based Access:

  • Different security templates can be applied to different roles for unprecedented flexibility and control.

Password Management

Password Aging:

  • Force a new password after a configurable amount of time.

Password Lockouts:

  • Lockout the account after a configurable number of retries.

Session Timeouts:

  • Logout from the application after a configurable session time-out period.