Training tracking learning management system Configurations

The administration module is the base system. Additional modules enhance capabilities with audit trail/electronic signature, learner and supervisor modules, report designer and SCORM conformance.

1. Administrative Module with or without access to SCORM compliant training materials

This is used to track and manage training related data and information. Compliance Training Manager Web is very similar to Training Manager in regard to functionality, features, interface and data processing. Training Manager is one of the top-rated training tracking and training management applications used mainly but not exclusively by the pharmaceutical and medical device industry. Many of the world's leading companies like Pfizer, Schering, Bristol Myers & Squibb, Organon Akzonobel, Wyeth, AstraZeneca, etc. (to name just a few) use it for many years. Compliance Training Manager Web not only provides all and any information you need but it also helps you to become and remain compliant if compliance is an important issue for you/ your company. Any documentation that might become important or required during an audit is only a mouse-click away. Data is stored in MS SQL 2000 database files while the application runs on a Windows 2000 or 2003 server in combination with Internet Information Services (IIS 6). The application and interface processing is done with the .Net Framework and therefore is not system dependent.

2. Employee / Learner Module with or without access to SCORM compliant training materials

This permits employees, learners, students, and etc. direct access to their own training data. It provides filtered but detailed information about Training History, Training Requirements and Training Schedules. Learners may enroll into scheduled classes or cancel previous enrollments. Automatic e-mail notifications and verifications are sent based on your settings. It functions as a content delivery system so employees / learners can read on-line documentation, can take tests, etc. and can sign off provided you accepted this option. This permits employees, learners, students, and etc. to read on-line documentation, can take tests, etc. and store results, elapsed time, questions, answers right or wrong, latency, weight.

3. Manager / Supervisor Module

Manager and Supervisors can review the training status, requirements status and scheduled sessions for employees / learners managed or supervised. In addition, managers and supervisors can enroll their employees / learners into already scheduled training classes or cancel previous enrollments. Any action taken here will trigger an automated e-mail, if this option was set-up by you, to make sure that persons affected by the decision will be notified. Furthermore, it allows managers and supervisors to make immediate and/ or very important decisions if i.e. a production employee has to be replaced outside regular office hours after calling-in sick.

4. End-User or Custom Report Designer

This module will be licensed to you and permits the creation of custom reports with point-and-click or drag-and-drop functionality. Any inexperienced computer users can, if needed, create an ad-hoc report, in minutes. In addition, you will also be able to modify any of the approximately 50 reports that are already built-into Compliance Training Manager Web. Web based: Can be run from any computer that has Internet Browser installed and does not need additional installation of system components. Integrated help system and can include and Audit Trail functionality with Electronic Signature. Data needed for documentation can be run as report to just review, print and/ or export as: MS Word Document (RTF - DOC), MS Excel Spreadsheet (XLS), Adobe Acrobat Reader (PDF) or Web Page (HTML) to be opened by any Internet Browser.

Compliance Types

Tracking of FDA 21 CFR Part 11 (electronic signature), ISO 9000, QS 9000, ISO 14000 QS, QA, GMP, OSHA, 508 Compliance, HIPAA.

Businesses served:

U.S. Navy, manufacturers, pharmaceutical, bio-tech, and medical device firms, distributors... any company can benefit from the ability to launch online learning and compliance documentation, assess and track training or other job-related activities!

Features

To gain access to specific features of Compliance Training Manager Web, three types of users are established:

Employee (read only), manager (read only: direct reports and their organization), and dept. and system admins. (read and write access) The Learner accessallows employees to enroll into scheduled classes or to cancel previous enrollments.



The Manager/ Supervisor access allows supervisors or managers to review their "managed" employees and to add or remove them from scheduled training sessions. Again, e-mail notification can be sent automatically.

The Application User accessallows administrative users with customized profiles to enroll persons into scheduled classes, maintain data for departments, job positions, employees (transfers and terminations), courses, revisions, instructors, job requirements (curricula), training schedules, training attendance, audit trail,and reports.

Compliance Training Manager Web uses a MS SQL 2000 database. Keeping your record information synchronized with other software systems that you now use is easily possible including updates as they relate to HR, Document Control System, etc.

• Creates documentation needed for regulatory compliance
  
• Existing data always displayed in spreadsheet-style layout
  
• Spreadsheets support Sort and Find functionality
  
• Help instructions available through mouse or help button
  
• Automatically check for pending revisions
  
• Automatically check for pending employee transfers
  
  
* Training history for each employee by type of training (GMP, Safety, IT, HR, etc.), course title, description, dates, etc.
• Employees can have multiple job codes/positions
  
• Same Job Code can be linked to more than one department
  
• Training courses with: Date Effective, End Date and Interval (repeat frequency)
  
• Requirements updated when saving course revision
  
  
* Version Control (SOP changes in LiveLink, learner is notified of the change and their need to address training on the new version)
• View terminated employees stored in external database
  
• Import terminated employee(s) and their training history for reporting
  
• Roll-back any pervious import
  
• Re-instate previously terminated employee including training history
  
  
* Reports
• Report section with almost 50 different reports
  
• Limit data based on any value in any data field of underlying database
  
• Filters (data queries) can have: AND or OR conditions
  
• Filter data based on: Exact match, greater than, smaller than, contains or "from – to" range
  
• Build multiple selection list based on user criteria
  
• Sort data using up to 5 database table fields
  
• Each field can be set to: Ascending or Descending independently
  
• Test filter condition
  
• Report title can be modified as needed
  
• Set page breaks if data is grouped
  
• Can reset page number upon page break
  
• Fill-in related dates automatically when reporting: Point-In-Time Compliance Audit
  
  
* Report Preview
• Preview with table of contents (tree view) enabling Locate and Find
  
• Can be saved as RTF file to be used in word processing programs
  
• Can be saved as PDF file for Acrobat Reader (e-mail attachment)
  
• Can be saved as delimited file for spreadsheet programs
  
• Can be saved as authentic MS Excel spreadsheet (.xls)
  
• Print any number of pages
  
  
* Audit Trail
• Refresh or rebuilt and archive Audit Trail database if permission is granted
  
• Review data contained in any database table of the Audit Trail if permission is granted
  
• Export data based on user specifications for review or printing if permission is granted
  
• Audit Trail data is encrypted and stored in a password-protected database
  
• Compliance with FDA 21CFR Part 11 regulatory guidlines for electronic signature and closed system.
  

The optional integrated Audit Trail and structural design makes it fully 21 CFR Part 11 compliant. This very essential Compliance Training Manager add-on is integrated into the application and conforms to: "Final Rule for 21 Code of Federal Regulations, Part 11. " The Audit Trail can be configured from within Compliance Training Manager.

Server Requirements (Intranet Server)

• Application Server (Windows 2000, 2003, etc.)
  
• IIS (Internet Information Server) 5.0 and higher
  
• MS SQL Database Server (SQL 2000 or better)
  
• Net Framework – any version

Client Requirements

Any computer connected to the Intranet Server with Internet Explorer 5 or better.

This software will work with almost all other Internet Browsers currently offered, too, but the interface functionality and appearance might differ slightly and some features might be missing. We found IE to be the best browser available for application development and execution because of its close interaction with the required .Net Framework. When running this system, the Internet Browser is used as application environment and not as browsing or Web surfing tool.

ASP hosting on Outsourced Server

This system can also be run on a server maintained by our Internet Service Provider while the Web application is maintained and updated by our software developers. When outsourcing, data contained in database files remains property of the end-user and is password-protected to guarantee that nobody else can access, read or alter records in any way.

Client Requirements remain the same as described above but, in addition, data can be accessed worldwide through any computer connected to the Internet.

ASP / Hosting delivery specifications:

Application server: Windows server like i.e.: Win 2000 or 2003 or comparable  
Database server: MS SQL 2000 or better  
Internet Information server: IIS 5 or better  
System environment: Framework 1.0 or later  
Internet browser: IE 5 or later  
Disk space application:
   Server space for application (min 250MB included in 5GB)
   Server space for SQL database (min 100MB included in 5GB)  
   Disk space for storing training content will increase depending on
      number of courses, documents, and test assessments.
   Expandable space for application and database
      (payable when needed)
   5Gb provided – can purchase added 100MB blocks.
 
Server Specification:
   CPU processor 2.5GHz or better if possible: Xeon Dual
   Secure (trusted) connection possibilities for data transfers
   Additional server for daily (nightly) Back-up of data
   Capability to restore from previous back-up
   Minimum 50GB of monthly bandwidth
      with the possibility to increase as needed
   Email capabilities with e-mail server
   Secure FTP site creation capabilities ( for direct data transfer)
   A "Web Control Center" to define and configure E-mail and FTP
   SQL database managing software

Costs

Compliance Training Manager Web is sold on a one-time cost (Perpetual License) starting at under $7,000.00 or Hosted (ASP) pricing starts at under $5,000.00 per year depending on features and number of learners. Annual cost for support, maintenance and upgrades is either $500 or $1000.
To investigate leasing of server equipment, our software and related services, visit our lease webpage.
To obtain specific pricing that suits your needs, contact us.

Click here to request a link to the Trial site. We are available to answer any questions in your evaluation.

Contact us now 866-776-8876 to schedule a walkthrough demonstration.