Quality Commitment & Reputation

• Makromed adheres to the quality standards of ISO 9001 & ISO 13485.
• InfoMed has been in use at hundreds of medical companies since 1990.
• InfoMed is in use at reputable companies like St. Jude, Chattem, Zoll, and Genzyme.

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.

Up-to-date with Underlying Regulations

• InfoMed complies with all additional requirements of MedWatch listed in FDA’s memo dated July 25, 1996
• When the FDA updates the MedWatch form, we update it in InfoMed
• InfoMed is the only system that allows separate tracking and filing of MedWatch reports for multiple manufacturing sites within the same system
• InfoMed includes Baseline Reporting module
• InfoMed has optional modules for CIOMS (pharmacovigilance), VAERS (vaccine-related reporting), MedDRA Library integration, Tissue Reporting, and Veterinary Drugs Reporting.
• InfoMed is the only system that maintains a dedicated electronic history file of all MDR deliberations, as required by the MDR regulation.
• InfoMed is the only system that provides decision trees for FDA’s MDRs/AERs and for the European Vigilance System, as well as for the corresponding regulations in Canada, Australia, and Japan.
• InfoMed is the only system that provides user maintainable Regulatory decision trees.
• InfoMed has enhanced security and audit trail features that comply with the electronic signature and records requirements of the 21 CFR Part 11 regulation.

Complaint Tracking from Beginning to End

Click here to see the Workflow diagram of InfoMed

• InfoMed organizes complaint handling process in a series of phases:
  • Customer service or complaint coordinators initiate new incident record
  • They can then be categorized as Complaints, and further classified as MDRs/AERs
  • Regulatory filings such as MedWatch or Vigilance can be generated
  • Investigation group then takes over and documents its findings
  • Complaint and investigation findings can be classified in user-defined categories
  • An acknowledgment, product return or closing letter to customers is auto generated
  • A corrective action may be initiated and monitored
  • Complaint can be officially closed

Complaint File Management

• InfoMed presents the history of complaints from a customer, product, lot number or any other parameter of interest instantly on demand

Reports and Trends

• InfoMed is the only system that includes 200+ built-in management reports, tables & graphs

System Configuration

• Infomed’s configuration module provides the following exclusive features:
  • User control of incident numbering format and protocol
  • User control of multiple manufacturing site setup for MedWatch submission
  • User control of business rules to enforce in the complaint handling process

Access Security

• InfoMed provides an elaborate security system to control user access of security data
  • Administrators with full acces
  • Users with full edit rights
  • Users with partial rights (ex: initiators can not edit investigation data, and vice versa)
  • Regulatory users
  • Read Only users
  • Password rules, encrypted passwords
  • Log of system access attempts -- successful and unsuccessful

Audit Trail

• InfoMed maintains a full audit trail of all data editing activities.

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

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
• Upgrades mandated by regulatory changes are provided at no additional cost

Training Seminars

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

System Requirements

• Windows 2000 or higher application server; Pentium IV or higher CPU; 1GB RAM plus 32MB RAM per user; 1GB disk space
• Pentium IV or higher or UNIX-based database server; 1GB RAM plus 32MB RAM per user; 20MB + 20MB per 1000 records disk space

Configurations

• Web application and database on same server, or on separate servers

Database

• InfoMed currently supports MS SQL backend database. Other backend databases, such as Oracle, are planned

Internet/Intranet

• InfoMed is now a web application, and only requires the client PC to have an internet browser to access the system
• Reports and trends are either in PDF format or a JSP page that can be saved and viewed using an internet browser. This allows easy e-mailing of reports and trends.