Element

How Makromed/InfoTrain Addresses It

A. Vendor Qualification

Quality Commitment & Reputation

• Makromed adheres to the quality standards of ISO 9001 & ISO 13485.
• Makromed has been providing software solutions for quality and regulatory compliance to the healthcare industry since 1990.

Quality Performance

• Makromed welcomes its customers to audit our operations.
• We maintain a formal Software Development Life Cycle (SDLC) system.
• All software documents, including software validation plan and report, are open for audits.

B. Basic Features

Up-to-date with Underlying Regulations

• InfoTrain lets you maintain a sound employee training program that meets the requirements of various quality and regulatory standards such as FDA’s GMP, QSR, and GTP regulations; ISO 9000 and ISO 13485 standards; and EU’s MDD regulation.
• InfoTrain allows you to define, track, and ensure the delivery of training requirements for employees.
• InfoTrain lets you maintain training records for employees.
• InfoTrain tracks and alerts for missing training.
• InfoTrain has enhanced security and audit trail features to address the electronic signature and records requirements of the 21 CFR Part 11 regulation.

Employee Training from Beginning to End

Click here to see the Workflow diagram of InfoTrain

• InfoTrain organizes employee training process in a series of phases:

• Set-up training modules and position/employee files.
• Define job descriptions, qualifications and training needs.
• Plan, schedule and scope a specific training.
• Track the training needs and invite the corresponding trainees to a specific training session.
• Conduct the training.
• Record the attendance and training results.
• Issue training certificates.
• Document trainees’ feedback.
• Close out the training record.

Training Management

• InfoTrain allows you to define training needs at various stages – initial, revision-based, and sustainment.  
• InfoTrain tracks both internal and external training.
• InfoTrain tracks the training history of employees and alerts to missing training.

Reports and Trends

• InfoTrain has built-in training forms for both internal and external training records.
• InfoTrain has built-in reports for tracking upcoming and overdue training.
• InfoTrain has training history reports for both the trainer and trainees.

Training Courses

Click here to see the details of training courses.

• Optional modules provide ready-to-use training courses on popular quality and regulatory topics.

C. Support Features

System Configuration

• InfoTrain’s configuration module provides the following features:

• User control of training numbering format and protocol.
• Attachment of related documents such as the organization chart, resume, and training handouts.

Access Security

• InfoTrain provides an elaborate security system to control user access of security data

• Administrators with full access
• Users with full edit rights
• Users with partial rights (ex: trainees can not edit training plan)
• ReadOnly users
• Password rules

Audit Trail

• InfoTrain maintains an audit trail of critical data editing activities, using the user name and date/time stamp and listing the modules and records edited.

Data Archiving

• InfoTrain provides a full built-in data archiving and retrieval system.

D. System Validation

Validation by Makromed

Click here to see the SDLC flowchart

• Validation performed in accordance with Makromed’s SDLC (Software Development Life Cycle).
• Certificate of Validation is included with the system.
• All validation documents are maintained at Makromed and are open for audits.

On-site Validation

• Work templates for Installation Qualification (IQ) and Operation Qualification (OQ) are included with the system.
• Makromed performs on-site IQ as part of the installation service, and offers on-site OQ.

E. Customer Support & Training

System Customization

• InfoTrain is the only system that includes free customization to your specification.
• All customized features are validated using the same process as on standard system.
• Customized features are carried forward to future upgrades at no additional cost.

Technical Support

• On-site installation on any computing environment is provided.
• Data migration from any existing source is provided.
• 12-months of technical support and warranty is included in the base system.
• Annual maintenance contract for extended support is available.

Training Seminars

• 2-day on-site training seminar for end users and administrators.
• Certificate of Training provided to all attendees.

F. Technical Issues

System Requirements

• Windows 95/98/NT4.0 or higher or 2000 or XP Professional; Pentium 200MHz or higher CPU; 64MB or higher RAM for Win95/98, 128MB or higher RAM for WinNT/2000, 256MB or higher RAM for WinXP; 150MB disk space.

Configurations

• Single-user, network, client/server, and web-enabled (Terminal Services)

Compatible Network Systems

• Novell, Microsoft NT, Microsoft 2000/2003

Database

• InfoTrain supports many popular backend databases such as Oracle, Microsoft SQL Server, Informix, and Paradox

Internet/Intranet

• Data and reports can be easily shared by remote sites via e-mail or publishing in PDF formats on internet/intranet.
• InfoTrain supports all MAPI compliant e-mail systems.