What is Guardian Trainer ?

Why do we need it ?

Quick Introduction

Guardian Trainer is a web product that will give businesses like pharmaceutical, biotechnology, medical device and other manufacturers the ability to:

• Establish "individual training programs" (ITP) for all manufacturing, staff and laboratory personnel.
• Provide training programs based on job function training requirements.
• Allow the employee to review all required training and reference materials, acknowledge the review and take associated tests online.
• Provide documents and reference materials in any media format that is currently support on the web.
• Provide requirements and status reports of what training has been completed and what job functions employees may perform.

Trainer is comprised of three major sections, "User Portal", "Authoring Tool" and "Administrator".

User Portal

This mode allows the employee to view all of their training requirements, what training has already been completed, and what training will lapse in the near future. It also gives them the ability to schedule themselves for classes, read and acknowledge online materials, take required tests, and review documents.

The employee is "in charge of their own destiny". Our main message is Self-Compliance = Self-Reliance. This program seamlessly handles time consuming and tedious activities associated with training. Guardian will allow training departments to focus on content development and effective training techniques instead of manual status checks and individual training notifications. Trainers can train without being bogged down by paperwork.

Authoring

Authoring has been built in to allow Training Administrators and key employees to facilitate the development of SOP, Job Function Training and other document types. Programs can be revised within authoring to allow for revisions and program expirations. All steps within the authoring module are audited for 21 CFR Part 11 capabilities.

Training Administrator

The training administrator is the heart and soul of the Guardian Trainer product. Using the administrator your entire facility or site can be modeled. By adding logical units such as Departments, Buildings or Work Areas, your training requirements are defined around the configuration of the plant. By using object-oriented principles, relationships can be established between logical units and training requirements.

Training relationships are setup in Parent-Child form. Where the parent may be a "Work Site" or "Manufacturing Line" and the Child could be a "Department" or "Logical Unit of Work". Just like a family tree, as you drill down through the branches you find the current applicable stuff to be in the leaf nodes. Leaf nodes contain the actual programs themselves (or training requirements).

Configuration of your site training requirements is done through the Guardian Explorer. Guardian Explorer uses a organization technique which we like to call "baskets". The "basket" is a unique data structure that allows for grouping of training requirements or other "baskets". Most training systems are flat and very 2 dimensional. Our training system has built in many real world concepts that training administrators can understand and leverage to ensure a smooth operation.

Reporting

Who needs training now ? Who is in full compliance to do task A? These are questions that the extremely user friendly GAP report can answer. The GAP report will show any "holes" or lapses in training requirements. Managers, supervisors, and employees can ensure that only adequately trained individuals are allowed to work on the process. Guardian Explorer can then be utilized to close the "gaps" and allow personnel to work within compliance standards while maintaining a 21 CFR, part 11 compliant audit trail that can be readily viewed by any user with administrator privileges.

To find out more, please contact a Guardian Representative now at 315.475.9182