InfoMed Exclusive Features

Regulatory

  • Auto generation of attachment pages for MedWatch submission, as needed.
  • Auto management of MedWatch submissions for multiple manufacturing sites from a single reporting site.
  • Regulatory modules for US FDA, EU Vigilance, Canada, Japan, and Australia.
  • Regulatory modules for devices, drugs, tissues, vaccines, and veterinary products.
  • Integration of adverse events submissions with MedDRA library.
  • User maintainable Regulatory decision trees.
  • Documented history of all Regulatory deliberations, including the answers to individual questions.

Complaint Files

  • Instant access to history of all complaints from a specific customer, on a product, lot number or any other field of interest.
  • Advanced search tools to locate specific complaints

Data Analysis

  • 200+ built-in reports, tables and graphs.
  • Efficiency report that highlights the bottlenecks in your complaint handling process.

Administration

  • User selectable auto generation of incident numbers and their format.
  • Elaborate security system that allows control of who can initiate new complaints, who makes Regulatory decisions, who edits investigation data, who has read-only rights, etc.
  • User selection of business rules to enforce in the complaint handling process.

Validation

  • Designed, developed, and validated in accordance with ISO 9000/ISO 13485-based SDLC process.
  • Certificate of Part 11 compliance and validation included in user documents.
  • On-site validation work templates included in user documents.

Customer Support

  • 12 months of free technical support included.
  • On-site installation service includes installation qualification (IQ) performed by our trained staff.
  • On-site installation service includes migration of data from other software, performed by our trained staff following a documented data migration script.
  • On-site 2-day training seminar for end users, supervisors, and administrators.