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.